Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (PRIMO)

June 6, 2016 updated by: Duke University
Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain and disability among adults. Many adults with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help adults improve OA-related outcomes. This study will examine three different approaches for helping adults manage their OA-related symptoms. The study will compare a patient-based intervention (involving exercise, weight management, and cognitive behavioral pain management), a provider-based intervention (involving provision of patient-specific recommendations for care, based on evidence-based guidelines), and a combination of the two interventions, relative to usual care among patients with hip and/or knee osteoarthritis. The interventions are relatively low cost and easy to disseminate, with the patient component being telephone based. This study will provide novel, valuable information of the effectiveness (and cost-effectiveness) of these three interventions in the context of real-world clinical settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evidence-based guidelines emphasize that adequate management of osteoarthritis (OA) requires a combination of both medical and behavioral modalities. However, many of the recommended guidelines are not regularly incorporated into clinical practice, and the recommended behavioral strategies (e.g. exercise and weight management) are not practiced by most patients. Prior studies have examined strategies for improving patient behaviors to manage OA-related symptoms, but few studies have examined provider-based interventions specifically for patients with OA, or combinations of patient- and provider-based interventions. The objective of this study is to compare a patient-based intervention (involving exercise, weight management, and cognitive behavioral pain management), a provider-based intervention (involving provision of patient-specific recommendations for care, based on evidence-based guidelines), and a combination of the two interventions, relative to usual care. This study will provide novel, valuable information of the effectiveness (and cost-effectiveness) of these three interventions in the context of real-world clinical settings.

This will be a randomized controlled trial involving the following four study arms: 1) Patient Behavioral Intervention for OA Only, 2) Provider Intervention for OA Only, 3) Patient Behavioral Intervention + Provider Intervention for OA, and 4) Usual Care Control (no intervention). Approximately 10 primary care practices in the Duke Primary Care Research Consortium (PCRC) will be randomized to either the Provider Intervention or Provider Control group. Within each clinic, patients with symptomatic knee and/or hip OA (n=560 total) will be randomly assigned to either the Patient Intervention or Patient Control group. Participants will be equally allocated between the four study groups, with randomization stratified according to gender and race (white/non-white).

The patient behavioral intervention will be a twelve-month program that includes the following elements: written educational materials (focused on exercise, weight management, and cognitive behavioral pain management), an exercise video tailored for patients with lower extremity OA, and telephone calls by a counselor to support behavior change. All participants in the study will continue with any other usual medical care they receive for OA. The provider intervention will involve giving information on patients' OA symptoms and treatment, as well as patient-specific evidence-based recommendations for care. Providers will have access to this information, as well as facilitated referrals for patient-specific treatment recommendations (e.g. physical therapy, orthopedics), at the point of clinical care.

The primary time point for outcome assessment will be at 12-months. The investigators will also assess a limited set of outcomes via telephone at 6-months, 18-months, and 24-months. Following completion of study follow-up assessments, participants who were not assigned to one of the two Participant arms will be given the materials for that intervention, and health care providers who were not part of one of the two Provider arms will be given the information involved in that intervention. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Secondary outcomes will include objective physical function (Short Physical Performance Test) and depressive symptoms (PHQ-8). The main study analyses will compare outcomes between the four study groups. The investigators will also assess the cost-effectiveness of the interventions.

Study Type

Interventional

Enrollment (Actual)

537

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Radiographic evidence of hip OA and/or radiographic evidence of or meets clinical criteria for knee OA
  • Current joint (hip and/or knee) symptoms
  • BMI >= 25
  • Physically inactive

Exclusion Criteria:

  • Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
  • Diagnosis of a motor neuron disease, Parkinson's disease, multiple sclerosis, or Paget's disease
  • Diagnosis of metastatic cancer
  • Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months
  • On waiting list for or planning arthroplasty
  • Total joint replacement (hip or knee) surgery, other hip or knee surgery, meniscus tear (verified by MRI), or ACL tear in the past 6 months
  • History of gout in hip or knee
  • Quadriplegia or paraplegia
  • Active diagnosis of psychosis or serious personality disorder
  • Diagnosis of dementia or other memory loss condition
  • Current, uncontrolled substance abuse disorder
  • Severly impaired speech or hearing (patients must be able to respond to phone calls)
  • No access to a telephone
  • Inability to understand and speak English
  • Blindness
  • Resident in nursing home
  • Serious / terminal illness as indicated by referral to hospice or palliative care
  • For females: currently pregnant or planning to become pregnant
  • No visit to their Duke primary health care provider in the last 18 months
  • Participating in another OA intervention of other lifestyle change study
  • Other self-reported medical problem that would prohibit participation in the study
  • Other health condition or personal issue judged by a study team member or primary care physician to make the patient inappropriate for study participation

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Patient Behavioral Intervention
Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Behavioral: Patient Behavioral Intervention for OA
Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Experimental: Provider Intervention
Primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.
Behavioral: Provider Intervention for OA
Primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.
Experimental: Patient and Provider Interventions
Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.
Behavioral: Combined Patient and Provider Interventions for OA
Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) from Baseline to 12-months.
Time Frame: Baseline and 12-months
Baseline and 12-months
Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 18-months post Baseline.
Time Frame: post Baseline,18-months
post Baseline,18-months
Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 24-months post Baseline.
Time Frame: post Baseline, 24-months
post Baseline, 24-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Short Physical Performance Test Protocol from Baseline to 12-months.
Time Frame: Baseline and 12-months
Baseline and 12-months
Change in the Patient Health Questionnaire (PHQ-8) from Baseline to 12-months.
Time Frame: Baseline and 12-months
Baseline and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Kelli D Allen, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (Estimate)

September 15, 2011

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00022836
  • R01AR059673 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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