Effects of Comprehensive Care for Knee OA
Completed · Phase 2
Conditions studied: Osteoarthritis
In brief
We will study 300 people with knee osteoarthritis (OA) who receive their medical care from a large health maintenance organization (HMO) in Indianapolis. Our study will evaluate a comprehensive plan for treatment of knee OA by primary care physicians. Primary care physicians will provide standard care for knee OA to half of the study participants (150 people), and will use the comprehensive treatment plan guidelines to treat the other half. The comprehensive plan includes careful use of medications along with non-drug approaches such as patient education, exercise, and social support. People who participate in the study will receive care for knee OA for 1 year. We will measure the results (outcomes) of treatment at the start of the study and at 3 months, 6 months, and 12 months after patients join the study. The results we will measure include joint pain, physical function, drug side effects, quality of life, satisfaction with OA care, and the cost of medical care.
Key facts
- Study ID
- NCT00000404
- Run by
- Indiana University
- People needed
- 300
- Starts
- 1997-04-01
- Expected to finish
- 2001-03-01
- Last updated by the study team
- 2013-04-30
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Study participants must be treated for chronic knee pain by a primary care physician at a participating HMO and satisfy American College of Rheumatology Clinical Criteria for the diagnosis of knee OA.
- All subjects will be able to read and write English, have a telephone, and give informed consent.
You may not qualify if…
- Significant hematologic, renal, hepatic, or cardiovascular disease (but not including mild/moderate hypertension) or any other serious medical condition that might preclude the subject's ability to participate fully in the project, keep clinic appointments, etc.
- Conditions other than knee OA which limit lower extremity function and mobility and/or would confound the evaluation of knee pain and function (e.g., clinically significant spinal or hip arthritis, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, stroke, etc.).
- A known "secondary" cause of OA, including acute or chronic infectious arthritis; crystal-induced arthritis; systemic inflammatory connective tissue disease (e.g., rheumatoid arthritis, systemic lupus erythematosus); osteonecrosis; Paget's disease; or metabolic diseases, such as hemochromatosis, Wilson's disease, or ochronosis.
Where it is running
- Long Hospital, Room 545 — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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