Patient Education in Rheumatoid Arthritis and Osteoarthritis

NCT ID: NCT00000414

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2001-04-30

Brief 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).

Detailed 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.

Conditions

Rheumatoid Arthritis; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arthritis Self-Management Program

small group self-management program

Group Type: EXPERIMENTAL

Arthritis Self-Management Program

Intervention Type: BEHAVIORAL

SMART Program

Self-Managed Arthritis Relief Therapy: mailed self management material

Group Type: EXPERIMENTAL

SMART Program

Intervention Type: BEHAVIORAL

Interventions

Arthritis Self-Management Program

Intervention Type: BEHAVIORAL

SMART Program

Intervention Type: BEHAVIORAL

Other Intervention Names

Self-Managed Arthritis Relief Therapy (SMART)

Eligibility Criteria

Inclusion Criteria

• Physician diagnosis of OA or RA
• Participation in the ARAMIS longitudinal study

Exclusion Criteria

• Age under 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kate Lorig

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kate R. Lorig, DrPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Wichita Arthritis Center

Wichita, Kansas, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Saskatoon

Edmonton, Alberta, Canada

Countries

United States; Canada

References

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. doi: 10.1097/01.mlr.0000118709.74348.65.

Reference Type: BACKGROUND

PMID: 15076811 (View on PubMed)

Other Identifiers

P01AR043584

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01 AR43584 Substudy 004

Identifier Type: -

Identifier Source: org_study_id