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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

Brief Summary:
This Study is a collaborative project with partners (people with scleroderma and stakeholders) designed to refine an internet program for patients with scleroderma and to compare the internet program to an authoritative educational book (Taking Charge of Systemic Sclerosis [TOSS]). During a 16-week comparative effectiveness 16-week randomized controlled trial, the investigators will recruit up to 250 patients who will be randomized to either TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and Families.

Condition or disease Intervention/treatment Phase
Scleroderma Other: Internet-based self-management program Other: Scleroderma book Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
Actual Study Start Date : March 6, 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Active Comparator: Internet-based self-management program
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.
Other: Internet-based self-management program
Education book group
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.
Other: Scleroderma book



Primary Outcome Measures :
  1. Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: Baseline compared with 16 weeks, 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale [ Time Frame: Baseline compared with 16 weeks, 6 months ]
    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).

  2. Change in Confidence in Self Management on the Patient Activation Measure Scale [ Time Frame: Baseline compared with 16 weeks, 6 months ]
    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".

  3. Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale [ Time Frame: Baseline compared with 16 weeks, 6 months ]
    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.

  4. Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  5. Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  6. Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  7. Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  8. Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  9. Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  10. Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  11. Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  12. Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  13. Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  14. Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.

  15. Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.


Other Outcome Measures:
  1. Change in PHQ-8 [ Time Frame: Baseline compared to 16 weeks and 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants will be residents of the United States
  • Diagnosed with systemic scleroderma,
  • 18 years of age
  • Possess basic computer literacy and have access to a computer with Internet and email capabilities
  • Have the ability to communicate in English

Exclusion Criteria:

  • No computer access
  • Inability to communicate in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494401


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
University of New Mexico
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Janet Poole University of New Mexico
Principal Investigator: Dinesh Khanna University of Michigan
Principal Investigator: Richard Silver Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Dinesh Khanna, MD, MS, University of Michigan:

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Responsible Party: Dinesh Khanna, MD, MS, Dinesh Khanna, MD,MS, PI, University of Michigan
ClinicalTrials.gov Identifier: NCT02494401     History of Changes
Other Study ID Numbers: CER-1310-08323.
First Posted: July 10, 2015    Key Record Dates
Results First Posted: August 15, 2019
Last Update Posted: August 27, 2019
Last Verified: August 2019
Keywords provided by Dinesh Khanna, MD, MS, University of Michigan:
systemic sclerosis
ssc
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases