Arthritis Self-Management Education Program

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT00467064
Collaborator
Stanford University (Other), Centers for Disease Control and Prevention (U.S. Fed)
690
2
2
26
345
13.3

Study Details

Study Description

Brief Summary

We will develop brief versions of the classic 6-week Arthritis Self-Management Program and evaluate their effectiveness.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Arthritis Quick Start
  • Other: Delayed treatment intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
690 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Arthritis Self-Management Education -- Dose Response
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

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.

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.

Other: Delayed treatment control

After 4 month delay, participants in Control Group receive Experimental intervention.

Other: Delayed treatment intervention
After four months delay, participants in Control Group receive Experimental workshop.

Outcome Measures

Primary Outcome Measures

  1. Self-Efficacy [10-1-05-9-30-09]

Secondary Outcome Measures

  1. Self-reported health [10-1-05-9-30-09]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adults, 18 years or older

  • Arthritis diagnosis

  • No prior participation in arthritis self-management

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Patient Education Research Center Palo Alto California United States 94304
2 University of North Carolina Center for Health Promotion & Disease Prevention Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • Stanford University
  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Jean Goeppinger, PhD, BSN, University of North Carolina, Chapel Hill
  • Principal Investigator: Kate Lorig, DrPH, BSN, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00467064
Other Study ID Numbers:
  • 06-0398-1-3
  • S3521-24/24
First Posted:
Apr 27, 2007
Last Update Posted:
Jan 28, 2010
Last Verified:
Jan 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2010