Arthritis Self-Management Education Program

This study has been completed.
Sponsor:
Collaborators:
Stanford University
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00467064
First received: April 25, 2007
Last updated: January 27, 2010
Last verified: January 2010
  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

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Self-Efficacy [ Time Frame: 10-1-05-9-30-09 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported health [ Time Frame: 10-1-05-9-30-09 ] [ Designated as safety issue: No ]

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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults, 18 years or older
  • Arthritis diagnosis
  • No prior participation in arthritis self-management
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467064

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
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Stanford University
Investigators
Principal Investigator: Jean Goeppinger, PhD, BSN University of North Carolina, Chapel Hill
Principal Investigator: Kate Lorig, DrPH, BSN Stanford University
  More Information

No publications provided

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

Keywords provided by University of North Carolina, Chapel Hill:
Disease self-management
Community programs

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 21, 2014