Completed

Effects of Comprehensive Care for Knee OA

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What is being tested

Patient education in self-care of knee OA

Behavioral
Who is being recruted

Osteoarthritis

Over 40 Years
+5 Eligibility Criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1997

Summary

Principal SponsorIndiana University
Last updated: April 30, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 1997Actual date on which the first participant was enrolled.

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. 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.

Official TitleEffects of Comprehensive Care for Knee Osteoarthritis (OA) 
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different combinations of treatments to see how they work together. This approach helps researchers determine whether a combination of treatments is more effective than a single treatment alone.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Osteoarthritis
Criteria
2 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
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
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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
Suspended
Long Hospital, Room 545Indianapolis, United StatesSee the location

CompletedOne Study Center
Effects of Comprehensive Care for Knee OA | PatLynk