Arthritis Self-Management Education Program

NCT ID: NCT00467064

Last Updated: 2010-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 690 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-12-31

Brief Summary

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

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.

Conditions

Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Arthritis self-management workshop

Comparison of two-week, lay led, scripted self-management workshop emphasizing action planning, problem-solving, and content specific to arthritis.

Group Type: EXPERIMENTAL

Arthritis Quick Start

Intervention Type: BEHAVIORAL

Two week, lay led, workshop focusing on goal setting, problem solving, and content specific to disease management.

Delayed treatment intervention

Intervention Type: OTHER

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.

Group Type: OTHER

Delayed treatment intervention

Intervention Type: OTHER

After four months delay, participants in Control Group receive Experimental workshop.

Interventions

Arthritis Quick Start

Two week, lay led, workshop focusing on goal setting, problem solving, and content specific to disease management.

Intervention Type: BEHAVIORAL

Delayed treatment intervention

After four months delay, participants in Control Group receive Experimental workshop.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults, 18 years or older
• Arthritis diagnosis
• No prior participation in arthritis self-management

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

UNC-Chapel Hill

Principal Investigators

Jean Goeppinger, PhD, BSN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Kate Lorig, DrPH, BSN

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Patient Education Research Center

Palo Alto, California, United States

University of North Carolina Center for Health Promotion & Disease Prevention

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

S3521-24/24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

06-0398-1-3

Identifier Type: -

Identifier Source: org_study_id