- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467064
Arthritis Self-Management Education Program
January 27, 2010 updated by: University of North Carolina, Chapel Hill
Arthritis Self-Management Education -- Dose Response
We will develop brief versions of the classic 6-week Arthritis Self-Management Program and evaluate their effectiveness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
690
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Palo Alto, California, United States, 94304
- Stanford University Patient Education Research Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Center for Health Promotion & Disease Prevention
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults, 18 years or older
- Arthritis diagnosis
- No prior participation in arthritis self-management
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Two week, lay led, workshop focusing on goal setting, problem solving, and content specific to disease management.
After four months delay, participants in Control Group receive Experimental workshop.
|
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Other: Delayed treatment control
After 4 month delay, participants in Control Group receive Experimental intervention.
|
After four months delay, participants in Control Group receive Experimental workshop.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-Efficacy
Time Frame: 10-1-05-9-30-09
|
10-1-05-9-30-09
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-reported health
Time Frame: 10-1-05-9-30-09
|
10-1-05-9-30-09
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean Goeppinger, PhD, BSN, University of North Carolina, Chapel Hill
- Principal Investigator: Kate Lorig, DrPH, BSN, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
April 25, 2007
First Submitted That Met QC Criteria
April 26, 2007
First Posted (Estimate)
April 27, 2007
Study Record Updates
Last Update Posted (Estimate)
January 28, 2010
Last Update Submitted That Met QC Criteria
January 27, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0398-1-3
- S3521-24/24 (Other Grant/Funding Number: CDC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.