Patient Education in Rheumatoid Arthritis and Osteoarthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Patient Education Strategies for Better Outcomes in Rheumatoid Arthritis (RA) and Osteoarthritis (OA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000414
• Other study ID #: P01 AR43584 Substudy 004
• Secondary ID: P01AR043584
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: June 19, 2013
• Start date: July 1996
• Est. completion date: April 2001

Study information

• Verified date: November 2004
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This project will evaluate the effectiveness and general usefulness of two arthritis patient education programs. The first, the Arthritis Self-Management Program, is a 6-week, community-based program taught in small groups by peer leaders. The second, the Self-Managed Arthritis Relief Therapy (SMART) Program, is a computer-driven program delivered through the mail. Participants in this project are people with rheumatoid arthritis or osteoarthritis who are taking part in the larger long-term studies being conducted by ARAMIS (the Arthritis, Rheumatism and Aging Medical Information System).

Description:

In a changing health care environment, the role of patients in managing their arthritis is increasingly important. Patient education is the primary means for teaching patients how to fulfill this role successfully. The goal of self-management health education is not merely to provide information but also to change patient attitudes and behavior so that patient outcomes are improved. These programs represent a new treatment for arthritis.

This project will evaluate the relative effect on health status and cost-effectiveness of two arthritis patient education programs that use different delivery systems. The Arthritis Self-Management Program (ASMP) uses a small group, multi-class format. It is taught by trained lay leaders and has been evaluated for effectiveness and widely disseminated. The Self-Managed Arthritis Relief Therapy (SMART) Program is a computer-driven, individualized, mail-delivered intervention. Results of a pilot study suggest that it is effective in improving health status and reducing health care use.

The project will also evaluate how generalizable the SMART program is and its effectiveness for patients with different diagnoses (OA and RA). It will also determine the attributes of patients who choose and do not choose to participate in patient education programs as well as the attributes of those who complete and do not complete the ASMP and SMART programs.

Through use of the ARAMIS data collection system, the project allows us to describe the differences between people who volunteer to receive patient education and those who refuse patient education. This project is directed at improving patient outcomes in both RA and OA through wide availability of a low-cost, mail-delivered arthritis self-management program that is the next generation in arthritis health education.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: April 2001
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Physician diagnosis of OA or RA

• Participation in the ARAMIS longitudinal study

Exclusion Criteria:

• Age under 18

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Behavioral:
• Arthritis Self-Management Program

• SMART Program

Locations

Country	Name	City	State
Canada	University of Saskatoon	Edmonton	Alberta
United States	Vanderbilt University	Nashville	Tennessee
United States	Stanford University	Palo Alto	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Wichita Arthritis Center	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Lorig KR, Ritter PL, Laurent DD, Fries JF. Long-term randomized controlled trials of tailored-print and small-group arthritis self-management interventions. Med Care. 2004 Apr;42(4):346-54. — View Citation