Completed

Effects of Comprehensive Care for Knee Osteoarthritis (OA)

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What is being tested

Patient education in self-care of knee OA

Behavioral
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

Over 40 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1997
See protocol details

Summary

Principal SponsorIndiana University
Last updated: April 30, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1997

Actual date on which the first participant was enrolled.

Anticipating trends toward generalism in medicine, the rheumatology community has begun to set forth guidelines for managing osteoarthritis (OA). These guidelines emphasize a comprehensive approach toward nondrug treatment (e.g., patient education, exercise, social support) and a conservative approach to drug management to minimize the side effects of nonsteroidal anti-inflammatory drugs (NSAIDs). Unfortunately, few primary care physicians provide conservative, comprehensive care for OA as promoted in the recent rheumatology literature. Also, although researchers have studied individual elements of a comprehensive approach to OA care and largely validated them in isolation, no research support exists to suggest that uniformly adopting OA care guidelines will result in better patient outcomes and/or reduced costs of care. In this project, we will implement, in a controlled fashion, and evaluate a comprehensive plan for treating patients with knee OA by primary care physicians in a managed care environment. Comprehensive care for knee OA will be guided by a procedure designed to introduce and reinforce (a) an array of nondrug, self-care procedures intended to combat joint pain and preserve function and (b) a stepped protocol for drug management of knee pain that minimizes the risk of adverse side effects of NSAIDs. Participants will be 300 patients with a confirmed clinical diagnosis of knee OA who receive their medical care in a large health maintenance organization (HMO) in Indianapolis, Indiana. We will randomly allocate geographically discrete offices of the HMOs to experimental (OA care by algorithm) or control (routine OA care) conditions (150 subjects/group). Patients who enroll in the study at each location will receive care for knee OA for 1 year under the guidelines specified by random assignment. We will measure outcomes at baseline and 3 months, 6 months, and 12 months after enrollment, and outcomes will include joint pain, physical function, drug side effects, quality of life (i.e., general health status), satisfaction with OA care, and direct costs of medical care. We think that comprehensive care, as guided by our algorithms, will result in significant improvement in knee pain, physical function, and patient satisfaction, and lower direct costs compared to care delivered under routine circumstances.

NCT00000404
Principal SponsorIndiana University
Last updated: April 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteoarthritis

Criteria

2 inclusion criteria required to participate
All subjects will be able to read and write English, have a telephone, and give informed consent

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

3 exclusion criteria prevent from participating
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

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.)

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Long Hospital, Room 545

Indianapolis, United StatesOpen Long Hospital, Room 545 in Google Maps
CompletedOne Study Center