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Arthritis Self-Management Education Program
This study is currently recruiting participants.
Verified by The University of North Carolina, Chapel Hill, April 2007
Sponsors and Collaborators: University of North Carolina
Stanford University
Centers for Disease Control and Prevention
Information provided by: The 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 Self-Management Education Workshop

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Arthritis Self-Management Education -- Dose Response

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

Primary Outcome Measures:
  • Self-Management Behaviors
  • Arthritis Self-Efficacy
  • Health-related Quality of Life (Self-reported Health, Pain, Disability, Fatigue, Activity Limitation, and Health Distress
  • Health Care Utilization

Estimated Enrollment: 700
Study Start Date: October 2006
Estimated Study Completion Date: July 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467064

Contacts
Contact: Jean Goeppinger, PhD, BSN 919-832-2213 jgoeppin@email.unc.edu

Locations
United States, California
Stanford University Patient Education Research Center Recruiting
Palo Alto, California, United States, 94304
Principal Investigator: Kate Lorig, DrPH, BSN            
United States, North Carolina
University of North Carolina Center for Health Promotion & Disease Prevention Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Jean Goeppinger, PhD, BSN            
Sponsors and Collaborators
University of North Carolina
Stanford University
Investigators
Principal Investigator: Jean Goeppinger, PhD, BSN The University of North Carolina, Chapel Hill
Principal Investigator: Kate Lorig, DrPH, BSN Stanford University
  More Information

Study ID Numbers: 06-0398-1-3
Study First Received: April 25, 2007
Last Updated: April 26, 2007
ClinicalTrials.gov Identifier: NCT00467064  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on January 15, 2009