NCT00000404

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 1997

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 1997

Completed
2.6 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
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

First QC Date

November 3, 1999

Last Update Submit

April 29, 2013

Conditions

Osteoarthritis

Keywords

Osteoarthritis (OA)KneeHMOComprehensive care

Interventions

Patient education in self-care of knee OABEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Hospital, Room 545

Indianapolis, Indiana, 46202-5103, United States

Location

Related Publications (3)

  • Mazzuca SA, Brandt KD, Katz BP, Dittus RS, Freund DA, Lubitz R, Hawker G, Eckert G. Comparison of general internists, family physicians, and rheumatologists managing patients with symptoms of osteoarthritis of the knee. Arthritis Care Res. 1997 Oct;10(5):289-99. doi: 10.1002/art.1790100503.

    PMID: 9362595BACKGROUND

  • Mazzuca SA, Brandt KD, Katz BP, Chambers M, Byrd D, Hanna M. Effects of self-care education on the health status of inner-city patients with osteoarthritis of the knee. Arthritis Rheum. 1997 Aug;40(8):1466-74. doi: 10.1002/art.1780400815.

    PMID: 9259427BACKGROUND

  • Mazzuca SA, Brandt KD, Katz BP, Hanna MP, Melfi CA. Reduced utilization and cost of primary care clinic visits resulting from self-care education for patients with osteoarthritis of the knee. Arthritis Rheum. 1999 Jun;42(6):1267-73. doi: 10.1002/1529-0131(199906)42:63.0.CO;2-E.

    PMID: 10366121BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Steven A. Mazzuca, Ph.D.

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

April 1, 1997

Study Completion

March 1, 2001

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

US(1)