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Trial record 1 of 1 for:    23170757 [PUBMED-IDS]
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Self-Management of Osteoarthritis (SeMOA)

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ClinicalTrials.gov Identifier: NCT00288912
Recruitment Status : Completed
First Posted : February 8, 2006
Results First Posted : September 12, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Osteoarthritis
Interventions Behavioral: Health Education
Behavioral: Osteoarthritis Self-Management
Enrollment 523
Recruitment Details Recruitment began on Oct 3, 2006 and ended on June 30, 2008. We used VA medical records to identify patients with hip and knee OA and no exclusionary diagnoses. We mailed introductory letters to these individuals and followed up with a screening phone call. Eligible patients were asked to come to the Durham VA for a baseline visit.
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Usual Medical Care

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

Period Title: Overall Study
Started 175 174 174
Completed 158 157 146
Not Completed 17 17 28
Reason Not Completed
Developed exclusion criterion             4             6             7
Lost to Follow-up             9             6             9
Withdrawal by Subject             4             5             12
Arm/Group Title Arm 1 Arm 2 Arm 3 Total
Hide Arm/Group Description

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Usual Medical Care

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

Total of all reporting groups
Overall Number of Baseline Participants 172 171 172 515
Hide Baseline Analysis Population Description
Among n=523 who consented and were randomized 8 were excluded from analyses because subsequent review of VA medical records revealed there was no documentation of radiographic evidence of knee or hip OA and therefore these participants did not meet initial eligibility requirements.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants 171 participants 172 participants 515 participants
60.3  (10.8) 59.7  (10.1) 60.3  (10.3) 60.1  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 171 participants 172 participants 515 participants
Female
12
   7.0%
10
   5.8%
15
   8.7%
37
   7.2%
Male
160
  93.0%
161
  94.2%
157
  91.3%
478
  92.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 172 participants 171 participants 172 participants 515 participants
White 91 92 95 278
Non-White 81 79 77 237
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 172 participants 171 participants 172 participants 515 participants
172 171 172 515
1.Primary Outcome
Title Pain
Hide Description Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale (“all days” to “no days”). The possible range of scores is 0-10, with higher scores indicating more severe pain.
Time Frame Baseline and 12-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Usual Medical Care

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

Overall Number of Participants Analyzed 172 171 172
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.01  (2.28) 5.77  (2.14) 5.92  (2.27)
12-Month Follow-Up 5.84  (2.32) 5.46  (2.03) 5.22  (2.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 3
Comments Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.0 to 0.2
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2, Arm 3
Comments Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.8 to 0.1
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
2.Secondary Outcome
Title AIMS 2 Physical Function
Hide Description The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse function.
Time Frame Baseline and 12-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Usual Medical Care

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

Overall Number of Participants Analyzed 172 171 172
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.70  (1.78) 2.27  (1.34) 2.60  (1.68)
12-Month Follow-Up 2.87  (1.94) 2.34  (1.55) 2.57  (1.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 3
Comments Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.0
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2, Arm 3
Comments Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.2
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
3.Secondary Outcome
Title AIMS 2 Affect
Hide Description The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse affect.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Usual Medical Care

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

Overall Number of Participants Analyzed 172 171 172
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.64  (2.26) 3.23  (2.04) 3.74  (2.29)
12-Month Follow-Up 3.44  (2.20) 3.08  (2.09) 3.58  (3.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 3
Comments Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.4
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2, Arm 3
Comments Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.3 to 0.4
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
4.Secondary Outcome
Title Arthritis Self Efficacy
Hide Description The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Usual Medical Care

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

Overall Number of Participants Analyzed 172 171 172
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.78  (2.01) 5.92  (1.92) 5.68  (2.07)
12-Month Follow-Up 5.80  (2.06) 5.96  (1.96) 6.09  (2.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 3
Comments Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.0 to 0.8
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2, Arm 3
Comments Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.0 to 0.7
Estimation Comments The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.
Time Frame [Not Specified]
Adverse Event Reporting Description We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
 
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Usual Medical Care

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

All-Cause Mortality
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/175 (5.71%)   7/174 (4.02%)   14/174 (8.05%) 
Cardiac disorders       
Hospital Admission [1]  2/175 (1.14%)  3/174 (1.72%)  7/174 (4.02%) 
Endocrine disorders       
Hospital Admission [1]  1/175 (0.57%)  0/174 (0.00%)  0/174 (0.00%) 
General disorders       
Death [1]  0/175 (0.00%)  0/174 (0.00%)  1/174 (0.57%) 
Hospital Admission [1]  0/175 (0.00%)  0/174 (0.00%)  1/174 (0.57%) 
Hepatobiliary disorders       
Hospital Admission [1]  0/175 (0.00%)  1/174 (0.57%)  0/174 (0.00%) 
Infections and infestations       
Hospital Admission [1]  0/175 (0.00%)  0/174 (0.00%)  1/174 (0.57%) 
Musculoskeletal and connective tissue disorders       
Hospital Admission [1]  1/175 (0.57%)  0/174 (0.00%)  0/174 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hospital Admission [1]  1/175 (0.57%)  0/174 (0.00%)  1/174 (0.57%) 
Significant Disability [1]  1/175 (0.57%)  0/174 (0.00%)  1/174 (0.57%) 
Nervous system disorders       
Significant Disability [1]  1/175 (0.57%)  0/174 (0.00%)  0/174 (0.00%) 
Renal and urinary disorders       
Hospital Admission [1]  1/175 (0.57%)  1/174 (0.57%)  0/174 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Hospital Admission [1]  1/175 (0.57%)  0/174 (0.00%)  0/174 (0.00%) 
Surgical and medical procedures       
Inpatient Surgery [1]  4/175 (2.29%)  6/174 (3.45%)  7/174 (4.02%) 
[1]
Not Study Related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/175 (18.86%)   25/174 (14.37%)   36/174 (20.69%) 
Cardiac disorders       
Emergency Room Visit [1]  0/175 (0.00%)  0/174 (0.00%)  2/174 (1.15%) 
Ear and labyrinth disorders       
Emergency Room Visit [1]  0/175 (0.00%)  0/174 (0.00%)  1/174 (0.57%) 
Eye disorders       
Emergency Room Visit [1]  1/175 (0.57%)  1/174 (0.57%)  0/174 (0.00%) 
Gastrointestinal disorders       
Emergency Room Visit [2]  2/175 (1.14%)  0/174 (0.00%)  6/174 (3.45%) 
General disorders       
Emergency Room Visit  11/175 (6.29%)  11/174 (6.32%)  13/174 (7.47%) 
Infections and infestations       
Emergency Room Visit [1]  1/175 (0.57%)  0/174 (0.00%)  0/174 (0.00%) 
Musculoskeletal and connective tissue disorders       
Emergency Room Visit [1]  20/175 (11.43%)  7/174 (4.02%)  19/174 (10.92%) 
Psychiatric disorders       
Emergency Room Visit [1]  2/175 (1.14%)  1/174 (0.57%)  0/174 (0.00%) 
Renal and urinary disorders       
Emergency Room Visit [1]  1/175 (0.57%)  1/174 (0.57%)  1/174 (0.57%) 
Respiratory, thoracic and mediastinal disorders       
Emergency Room Visit [1]  1/175 (0.57%)  5/174 (2.87%)  7/174 (4.02%) 
Skin and subcutaneous tissue disorders       
Emergency Room Visit [1]  2/175 (1.14%)  1/174 (0.57%)  0/174 (0.00%) 
Surgical and medical procedures       
Outpatient Surgery [1]  10/175 (5.71%)  10/174 (5.75%)  14/174 (8.05%) 
Vascular disorders       
Emergency Room Visit [1]  1/175 (0.57%)  0/174 (0.00%)  0/174 (0.00%) 
[1]
Not Study Related
[2]
Not study-related
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kelli Allen
Organization: Durham VA HSR&D
Phone: 919-286-0411 ext 7090
Publications of Results:
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00288912     History of Changes
Other Study ID Numbers: IIR 04-016
First Submitted: February 6, 2006
First Posted: February 8, 2006
Results First Submitted: August 1, 2014
Results First Posted: September 12, 2014
Last Update Posted: April 24, 2015