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Patient Education in Rheumatoid Arthritis and Osteoarthritis

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arthritis Self-Management Program
SMART Program
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis (RA), Osteoarthritis (OA), Arthritis education, Health care service evaluation, Outcomes research, Arthritis Self-Management Program (ASMP), Self-Managed Arthritis Relief Therapy (SMART) Program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Physician diagnosis of OA or RA Participation in the ARAMIS longitudinal study Exclusion Criteria: Age under 18

Sites / Locations

  • Stanford University
  • Wichita Arthritis Center
  • University of Pittsburgh
  • Vanderbilt University
  • University of Saskatoon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arthritis Self-Management Program

SMART Program

Arm Description

small group self-management program

Self-Managed Arthritis Relief Therapy: mailed self management material

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 19, 2013
Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000414
Brief Title
Patient Education in Rheumatoid Arthritis and Osteoarthritis
Official Title
Patient Education Strategies for Better Outcomes in Rheumatoid Arthritis (RA) and Osteoarthritis (OA)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
April 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis
Keywords
Rheumatoid arthritis (RA), Osteoarthritis (OA), Arthritis education, Health care service evaluation, Outcomes research, Arthritis Self-Management Program (ASMP), Self-Managed Arthritis Relief Therapy (SMART) Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthritis Self-Management Program
Arm Type
Experimental
Arm Description
small group self-management program
Arm Title
SMART Program
Arm Type
Experimental
Arm Description
Self-Managed Arthritis Relief Therapy: mailed self management material
Intervention Type
Behavioral
Intervention Name(s)
Arthritis Self-Management Program
Intervention Type
Behavioral
Intervention Name(s)
SMART Program
Other Intervention Name(s)
Self-Managed Arthritis Relief Therapy (SMART)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physician diagnosis of OA or RA Participation in the ARAMIS longitudinal study Exclusion Criteria: Age under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate R. Lorig, DrPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Wichita Arthritis Center
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
University of Saskatoon
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15076811
Citation
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.
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Patient Education in Rheumatoid Arthritis and Osteoarthritis

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