Clinical trial NCT00467064: Arthritis Self-Management Education Program
Official title: Arthritis Self-Management Education -- Dose Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: Disease self-management
Community programs
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Centers for Disease Control and Prevention
First posted: 2007-04-27
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Self-Efficacy
timeFrame: 10-1-05-9-30-09
Secondary outcomes:
measure: Self-reported health
timeFrame: 10-1-05-9-30-09
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Patient Education Research Center
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina Center for Health Promotion & Disease Prevention
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jean Goeppinger, PhD, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Kate Lorig, DrPH, BSN
role: PRINCIPAL_INVESTIGATOR
References: