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Taking Charge of Systemic Sclerosis (TOSS)

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ClinicalTrials.gov Identifier: NCT02494401
Recruitment Status : Completed
First Posted : July 10, 2015
Results First Posted : August 15, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborators:
University of New Mexico
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Dinesh Khanna, MD, MS, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Scleroderma
Interventions Other: Internet-based self-management program
Other: Scleroderma book
Enrollment 267
Recruitment Details Study recruitment occurred at two sites, The University of Michigan and the Medical University of South Carolina. Recruitment also took place utilizing social media, with the help of our patient partners and the Sclerderma Foundation and Scleroderma Research Foundation.
Pre-assignment Details Participants completed baseline questionnaires. Participants were randomized to the intervention or control condition using a 1:1 ratio and computer-generated block randomization, and were stratified based on scores on the Patient Health Questionnaire-8 (<10, >10) in the baseline questionnaire.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Period Title: Overall Study
Started 134 133
Week 16 123 124
6 Month Follow up 109 106
Completed 109 106
Not Completed 25 27
Reason Not Completed
Lost to Follow-up             22             25
Withdrawal by Subject             3             2
Arm/Group Title Internet-based Self-management Program Education Book Group Total
Hide Arm/Group Description

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Total of all reporting groups
Overall Number of Baseline Participants 134 133 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 133 participants 267 participants
54.3  (10.1) 52.9  (13.1) 53.7  (11.7)
[1]
Measure Description: age at time of enrollment
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 133 participants 267 participants
Female
123
  91.8%
120
  90.2%
243
  91.0%
Male
11
   8.2%
13
   9.8%
24
   9.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 133 participants 267 participants
Hispanic or Latino
7
   5.2%
4
   3.0%
11
   4.1%
Not Hispanic or Latino
105
  78.4%
102
  76.7%
207
  77.5%
Unknown or Not Reported
22
  16.4%
27
  20.3%
49
  18.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 133 participants 267 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.7%
3
   2.3%
4
   1.5%
Native Hawaiian or Other Pacific Islander
2
   1.5%
0
   0.0%
2
   0.7%
Black or African American
7
   5.2%
13
   9.8%
20
   7.5%
White
112
  83.6%
109
  82.0%
221
  82.8%
More than one race
11
   8.2%
5
   3.8%
16
   6.0%
Unknown or Not Reported
1
   0.7%
3
   2.3%
4
   1.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 134 participants 133 participants 267 participants
134
 100.0%
133
 100.0%
267
 100.0%
Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 134 participants 133 participants 267 participants
47.41  (9.15) 47.58  (7.81) 47.50  (8.49)
[1]
Measure Description: Managing Symptoms score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident). The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 133 participants 267 participants
Mobility 1.53  (0.52) 1.61  (0.49) 1.57  (0.50)
Self-Care 1.28  (0.48) 1.79  (0.49) 1.31  (0.49)
Usual Activities 1.78  (0.50) 1.79  (0.43) 1.79  (0.46)
Pain Discomfort 1.93  (0.48) 2.02  (0.43) 1.98  (0.46)
Anxiety 1.56  (0.61) 1.63  (0.62) 1.60  (0.61)
Visual Analogue Scale 67.47  (18.01) 63.72  (17.33) 65.6  (17.74)
EQ-5D Index 0.71  (0.18) 0.69  (0.16) 0.70  (0.17)
[1]
Measure Description:

The (EQ-5D) provides a generic health-related quality of life assessment. The 5 domains listed in each row are scored into 3 levels, level 1 (no problem), level 2 (some problems), level 3 (extreme problems).

Visual analogue scale is a vertical scale with end points of 0 and 100, 0 corresponds to " the worst health you can imagine", and 100 corresponds to "the best health you can imagine".

Using a conversion algorithm, the EQ-5D index patient responses are converted into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health).

Confidence in Self Management on the Patient Activation Measure Scale   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 133 participants 267 participants
Patient Activation Level 1
14
  10.4%
14
  10.5%
28
  10.5%
Patient Activation Level 2
15
  11.2%
15
  11.3%
30
  11.2%
Patient Activation Level 3
23
  17.2%
27
  20.3%
50
  18.7%
Patient Activation Level 4
82
  61.2%
77
  57.9%
159
  59.6%
[1]
Measure Description: The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management.PAM scores were categorized into 4 levels: level 1, the individual is disengaged/overwhelmed; level 2, the individual is aware but struggling; level 3, the individual is taking action;and level 4, the individual is maintaining behavior.The summed score is finally transformed into a 0-100 point scale with higher scores indicating more confidence and knowledge in patients managing their condition
Appearance Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 133 participants 267 participants
17.1  (9.53) 16.81  (8.13) 16.96  (8.85)
[1]
Measure Description: The Brief Satisfaction with Appearance Scale (SWAP) is a 6-item scale measuring body image concerns and social discomfort with body parts. It is scored from 0 to 36, with higher scores associated with greater dissatisfaction.
Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8   [1] 
Mean (Standard Deviation)
Unit of measure:  T-score
Number Analyzed 134 participants 133 participants 267 participants
44.83  (7.60) 44.71  (6.77) 44.77  (7.19)
[1]
Measure Description: Managing Daily Activities score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage daily actvities.
Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 [   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 134 participants 133 participants 267 participants
46.78  (9.29) 46.34  (8.75) 46.56  (9.01)
[1]
Measure Description: Managing Emotions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident) this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage emotions.
Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 134 participants 133 participants 267 participants
49.15  (9.06) 50.3  (8.29) 49.72  (8.69)
[1]
Measure Description: Managing Medication and Treatment score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident) this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage medications and treatments.
Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8   [1] 
Mean (Standard Deviation)
Unit of measure:  T Score
Number Analyzed 134 participants 133 participants 267 participants
46.57  (9.74) 46.66  (8.96) 46.62  (9.34)
[1]
Measure Description: Managing Social Interactions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident) this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage social interactions.
Physical Function scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T Score
Number Analyzed 134 participants 133 participants 267 participants
40.63  (6.95) 40.17  (6.15) 40.4  (6.95)
[1]
Measure Description: Physical Function domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10.A higher score represents better physical function, a lower score represents poorer physical function.
Social Role scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T Score
Number Analyzed 134 participants 133 participants 267 participants
43.74  (8.63) 44.39  (7.68) 44.06  (8.17)
[1]
Measure Description: Social role domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Anxiety scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T Score
Number Analyzed 134 participants 133 participants 267 participants
53.85  (9.72) 54.11  (10.31) 53.98  (10.0)
[1]
Measure Description: Anxiety domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Depression scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 134 participants 133 participants 267 participants
51.04  (10.03) 51.59  (9.69) 51.31  (9.85)
[1]
Measure Description: Depression domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Fatigue scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 134 participants 133 participants 267 participants
58.47  (10.52) 58.91  (10.31) 58.69  (10.40)
[1]
Measure Description: Fatigue domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Pain Interference scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 134 participants 133 participants 267 participants
57.99  (9.37) 57.92  (9.22) 57.95  (9.28)
[1]
Measure Description: Pain interference domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much). A raw score is created from each short form that makes up the Profile. To find the total raw score for a short form with all questions answered, sum the values of the response to each question within each domain. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Visual Analogue Scale Pain Intensity scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T Score
Number Analyzed 134 participants 133 participants 267 participants
4.08  (2.21) 4.25  (2.26) 4.16  (2.24)
[1]
Measure Description: the visual analogue scale pain intensity in the PROMIS-29 Profile v2.0® are scored as 0 being no pain and 10 being the worst imaginable pain.
Sleep Disturbance scale on the PROMIS® 29 Profile v 2.0 outcome measure   [1] 
Mean (Standard Deviation)
Unit of measure:  T-score
Number Analyzed 134 participants 133 participants 267 participants
55.22  (6.96) 56.18  (7.84) 55.7  (7.41)
[1]
Measure Description: Sleep disturbance domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
PHQ-8   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 133 participants 267 participants
8.61  (5.39) 8.72  (4.98) 8.67  (5.18)
[1]
Measure Description: The Patient Health Questionnaire-8 (PHQ-8) is an 8-item questionnaire that is commonly used to measure depressive symptoms. The minimum score is 0 with a maximum score of 24. A score of ≥10 is consistent with depressed mood, a score of ≥20 is consistent with severely depressed mood.
1.Primary Outcome
Title Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
Hide Description Managing Symptoms score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time Frame Baseline compared with 16 weeks, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.35  (6.12) 0.94  (6.79)
6 months Number Analyzed 109 participants 106 participants
0.50  (7.13) 1.49  (6.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments p value of baseline comparison.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments p value for 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments p value for 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale
Hide Description EQ-5D index scale uses a conversion algorithm to convert the raw scores into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health).
Time Frame Baseline compared with 16 weeks, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.002  (0.14) 0.02  (0.14)
6 months Number Analyzed 109 participants 106 participants
0.002  (0.12) 0.04  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments p value 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments p value 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Change in Confidence in Self Management on the Patient Activation Measure Scale
Hide Description The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. Each item is scored from 1 (strongly disagree) to 4 (strongly agree). PAM scores were categorized into 4 levels: level 1, the individual is disengaged/overwhelmed; level 2, the individual is aware but struggling; level 3, the individual is taking action;and level 4, the individual is maintaining behavior. The analysis will look at any change in these levels where level 4 denotes someone as full "activated".
Time Frame Baseline compared with 16 weeks, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: PAM level
16 weeks Number Analyzed 123 participants 124 participants
0.83  (4.98) 0.98  (5.55)
6 months Number Analyzed 109 participants 106 participants
0.90  (5.22) 1.70  (4.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments p value baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale
Hide Description The Brief Satisfaction with Appearance Scale (SWAP) is a 6-item scale measuring body image concerns and social discomfort with body parts. It is scored from 0 to 36, with higher scores associated with greater dissatisfaction.
Time Frame Baseline compared with 16 weeks, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.82  (10.58) 0.31  (9.56)
6 months Number Analyzed 109 participants 106 participants
0.18  (10.19) 0.91  (9.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8
Hide Description Managing Daily Activities score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.17  (5.11) 0.79  (4.52)
6 months Number Analyzed 109 participants 106 participants
0.04  (4.56) 0.48  (6.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments p value baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments p value for 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8
Hide Description Managing Emotions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.09  (6.28) 0.73  (5.34)
6 months Number Analyzed 109 participants 106 participants
0.71  (7.61) 1.22  (7.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments p value for baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments p value for 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments p value for 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8
Hide Description Managing Medication and Treatment score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.54  (7.59) 0.70  (6.29)
6 months Number Analyzed 109 participants 106 participants
0.89  (8.31) 0.49  (8.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments p value for baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments p value for 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments p value for 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8
Hide Description Managing Social Interactions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.43  (6.94) 0.99  (7.42)
6 months Number Analyzed 109 participants 106 participants
0.40  (8.12) 1.47  (7.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description Physical Function domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents better physical function, a lower score represents poorer physical function.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.05  (5.71) 0.75  (4.83)
6 months Number Analyzed 109 participants 106 participants
0.09  (4.93) 1.08  (5.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description Social role domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents better social role functioning and a lower score represents poorer social role functioning.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
2.05  (17.19) 2.24  (15.58)
6 months Number Analyzed 109 participants 106 participants
1.19  (17.15) 1.65  (15.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description Anxiety domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.16  (6.93) 0.86  (7.64)
6 months Number Analyzed 109 participants 106 participants
0.40  (8.55) -1.14  (8.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description Depression domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.08  (6.40) 0.13  (6.76)
6 months Number Analyzed 109 participants 106 participants
0.61  (7.75) -1.23  (7.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description Fatigue domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.005  (6.90) 0.20  (7.19)
6 months Number Analyzed 109 participants 106 participants
0.78  (6.90) -1.36  (8.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description Pain interference domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
-0.65  (6.96) -0.80  (6.95)
6 months Number Analyzed 109 participants 106 participants
-0.58  (7.29) -1.03  (8.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Secondary Outcome
Title Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description The visual analogue scale pain intensity in the PROMIS-29 Profile v2.0® is scored as 0 being no pain and 10 being the worst imaginable pain.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
0.11  (1.78) 0.19  (1.78)
6 months Number Analyzed 109 participants 107 participants
0.02  (1.91) -0.09  (2.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Hide Description Sleep disturbance domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
-2.95  (6.22) -3.40  (6.62)
6 months Number Analyzed 109 participants 106 participants
-1.30  (6.74) -1.92  (6.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Other Pre-specified Outcome
Title Change in PHQ-8
Hide Description The Patient Health Questionnaire-8 (PHQ-8) is an 8-item questionnaire that is commonly used to measure depressive symptoms. A score of ≥10 is consistent with depressed mood with a score ranging from 0 to 24.
Time Frame Baseline compared to 16 weeks and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed at 6 months differs due to drop outs shown in participant flow table.
Arm/Group Title Internet-based Self-management Program Education Book Group
Hide Arm/Group Description:

Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

Overall Number of Participants Analyzed 123 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
16 weeks Number Analyzed 123 participants 124 participants
-1.19  (5.02) -1.27  (4.99)
6 months Number Analyzed 109 participants 106 participants
-1.79  (5.06) 1.63  (5.12)
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Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments p value of baseline comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments p value of 16 week comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Internet-based Self-management Program, Education Book Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments p value of 6 month comparison
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Internet-based Self-management Program Education Book Group
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Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.

Internet-based self-management program

Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.

Scleroderma book

All-Cause Mortality
Internet-based Self-management Program Education Book Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/134 (0.75%)   0/133 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Internet-based Self-management Program Education Book Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/134 (0.00%)   0/133 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Internet-based Self-management Program Education Book Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/134 (0.00%)   0/133 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janet Poole
Organization: University of New Mexico
Phone: (505) 272-1753
EMail: JPoole@salud.unm.edu
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Responsible Party: Dinesh Khanna, MD, MS, University of Michigan
ClinicalTrials.gov Identifier: NCT02494401     History of Changes
Other Study ID Numbers: CER-1310-08323.
First Submitted: May 22, 2015
First Posted: July 10, 2015
Results First Submitted: October 9, 2018
Results First Posted: August 15, 2019
Last Update Posted: August 27, 2019