NCT00000414

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 1996

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
Last Updated

June 21, 2013

Status Verified

November 1, 2004

Enrollment Period

4.8 years

First QC Date

November 3, 1999

Last Update Submit

June 19, 2013

Conditions

Rheumatoid ArthritisOsteoarthritis

Keywords

Rheumatoid arthritis (RA)Osteoarthritis (OA)Arthritis educationHealth care service evaluationOutcomes researchArthritis Self-Management Program (ASMP)Self-Managed Arthritis Relief Therapy (SMART) Program

Study Arms (2)

Arthritis Self-Management Program

EXPERIMENTAL

small group self-management program

Behavioral: Arthritis Self-Management Program

SMART Program

EXPERIMENTAL

Self-Managed Arthritis Relief Therapy: mailed self management material

Behavioral: SMART Program

Interventions

Arthritis Self-Management ProgramBEHAVIORAL
Arthritis Self-Management Program
SMART ProgramBEHAVIORAL
Also known as: Self-Managed Arthritis Relief Therapy (SMART)
SMART Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford University

Palo Alto, California, 94305, United States

Location

Wichita Arthritis Center

Wichita, Kansas, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Vanderbilt University

Nashville, Tennessee, United States

Location

University of Saskatoon

Edmonton, Alberta, Canada

Location

Related 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. doi: 10.1097/01.mlr.0000118709.74348.65.

    PMID: 15076811BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kate R. Lorig, DrPH

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1996

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

June 21, 2013

Record last verified: 2004-11

Locations

US(4)CA(1)