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| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Collaborators: |
Stanford University Centers for Disease Control and Prevention |
| Information provided by: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00467064 |
Purpose
We will develop brief versions of the classic 6-week Arthritis Self-Management Program and evaluate their effectiveness.
| Condition | Intervention |
|---|---|
|
Arthritis |
Behavioral: Arthritis Quick Start Other: Delayed treatment intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Arthritis Self-Management Education -- Dose Response |
| Enrollment: | 690 |
| Study Start Date: | October 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arthritis self-management workshop
Comparison of two-week, lay led, scripted self-management workshop emphasizing action planning, problem-solving, and content specific to arthritis.
|
Behavioral: Arthritis Quick Start
Two week, lay led, workshop focusing on goal setting, problem solving, and content specific to disease management.
Other: Delayed treatment intervention
After four months delay, participants in Control Group receive Experimental workshop.
|
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Delayed treatment control
After 4 month delay, participants in Control Group receive Experimental intervention.
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Other: Delayed treatment intervention
After four months delay, participants in Control Group receive Experimental workshop.
|
Many national statements have been made recently about the importance of evidence-based arthritis self-management to improvements in the public's health. The prevalence of arthritis is increasing as the US population ages; the prevalence of arthritis-related disability is higher among Blacks than Whites. Effective arthritis self-management education programs with varying formats have been developed and found effective. Despite this, many Arthritis Foundation chapters and arthritis units of state health departments have found dissemination difficult, and cite the time demands (6 weekly sessions, 2 hours/session) of the classic arthritis self-management education program (ASMP) as a major barrier. Researchers at the University of North Carolina at Chapel Hill and Stanford University will develop and evaluate two "low dose" arthritis self-management programs. The study will be conducted in three phases. Phase One (Development): Researchers will conduct needs assessments with arthritis self-management program disseminators, rheumatologists and other arthritis health professionals, and potential program users to determine preferred content, length, and schedule. Using findings from these assessments, researchers will develop two "low dose" versions of the ASMP. Phase Two (Implementation and Evaluation): Researchers will evaluate the "response" (effectiveness) of both "low dose" interventions in a randomized controlled trial (4 months) and a longitudinal study (one year). We will measure four outcomes: (1) Self-Management Behaviors, (2) Arthritis Self-Efficacy, (3) Health-related Quality of Life (Self-reported Health, Pain, Disability, Fatigue, Activity Limitation, and Health Distress); and (4) Health Care Utilization. A sample of 700 adults with diagnosed arthritis or chronic joint pain, including 200 African Americans, will participate in the study. All data will be gathered via self-administered mailed questionnaires, with telephone follow-up as needed. We will use analysis of co-variance and structural equation modeling to evaluate effectiveness. Researchers will also compare the effectiveness of each new "low dose" program with the effectiveness of existing arthritis self-management education program options. Phase Three (Dissemination): We will consult with arthritis units of state health departments and state chapters of the Arthritis Foundation on program adoption and distribution.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University Patient Education Research Center | |
| Palo Alto, California, United States, 94304 | |
| United States, North Carolina | |
| University of North Carolina Center for Health Promotion & Disease Prevention | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Jean Goeppinger, PhD, BSN | University of North Carolina, Chapel Hill |
| Principal Investigator: | Kate Lorig, DrPH, BSN | Stanford University |
More Information
| Responsible Party: | Jean Goeppinger, UNC-Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00467064 History of Changes |
| Other Study ID Numbers: | 06-0398-1-3, S3521-24/24 |
| Study First Received: | April 25, 2007 |
| Last Updated: | January 27, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Disease self-management Community programs |
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Arthritis Joint Diseases Musculoskeletal Diseases |