Patient Education in Rheumatoid Arthritis and Osteoarthritis

June 19, 2013 updated by: Kate Lorig, Stanford University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Saskatoon
  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Kansas
      • Wichita, Kansas, United States
        • Wichita Arthritis Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arthritis Self-Management Program
small group self-management program
Behavioral: Arthritis Self-Management Program
Experimental: SMART Program
Self-Managed Arthritis Relief Therapy: mailed self management material
Behavioral: SMART Program
Other Names:
  • Self-Managed Arthritis Relief Therapy (SMART)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

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

Investigators

  • Principal Investigator: Kate R. Lorig, DrPH, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1996

Primary Completion (Actual)

April 1, 2001

Study Completion (Actual)

April 1, 2001

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

November 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01 AR43584 Substudy 004
  • P01AR043584 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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