Coping Skills Training for Early Rheumatoid Arthritis
3 other identifiers
interventional
105
1 country
2
Brief Summary
Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health problem. Medical treatments are now being used much earlier in the course of RA, but these treatments do not address the challenges of coping with the early stages of this disease. This study will determine whether a comprehensive coping skills training program can decrease pain, psychological disability, and physical disability in patients with early RA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Feb 2003
Longer than P75 for not_applicable rheumatoid-arthritis
2 active sites
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
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 11, 2003
CompletedFirst Posted
Study publicly available on registry
March 12, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedOctober 25, 2018
November 1, 2013
6.2 years
March 11, 2003
October 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain
Measured at Week 10
Psychological disability
Measured at Week 10
Physical disability
Measured at Week 10
Secondary Outcomes (5)
Erythrocyte sedimentation rate
Measured at Week 10
Joint tenderness count
Measured at Week 10
Grip strength
Measured at Week 10
Physician assessment of disease activity
Measured at Week 10
C reactive protein
Measured at Week 10
Study Arms (3)
1
EXPERIMENTALParticipants will receive comprehensive pain coping skills.
2
ACTIVE COMPARATORParticipants will receive arthritis education.
3
ACTIVE COMPARATORParticipants will receive standard care.
Interventions
10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.
10 weekly, 80-minute treatment sessions, followed by a series of six biweekly follow-up telephone calls. Participants will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection.
Eligibility Criteria
You may qualify if:
- Meet at least 4 of the 7 criteria for RA classification based on the 1987 American College of Rheumatology criteria
- Onset of RA symptoms within 2 years of study entry
You may not qualify if:
- Known organic disease that significantly affects function
- Rheumatic disorders in addition to RA that significantly affect function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Duke University
Durham, North Carolina, 27705, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis J. Keefe, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2003
First Posted
March 12, 2003
Study Start
February 1, 2003
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
October 25, 2018
Record last verified: 2013-11