Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults.

Study Overview
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Brief Summary
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Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement independent of health care access, and are less likely to receive knee replacement. The study is conducted to develop and test a telephone delivered intervention for the management of OA in Hispanic adults. This study is conducted as a minority supplement to the Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (PRIMO) NCT01435109 and Pro00022836.

Detailed Description
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Arthritis affects approximately 50 million adults in the United States (US), making it one of the most common causes of disability in this county. In addition, is associated with significant physical activity limitations, increased prevalence of obesity, decreased health related quality of life, and increased health care costs. Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement independent of health care access, and are less likely to receive knee replacement. In addition, there have been very few interventions to improve either medical or behavioral aspects of OA treatment recommendations among the Hispanic population. The study will developed and test a culturally appropriate Spanish educational materials and telephone scripts for the patient- and provider-based interventions and will test the patient and provider intervention in a group of Adult Hispanics with OA.

Official Title
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Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Behavioral: patient and provider intervention


Participation Criteria
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Eligibility Criteria
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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 Spanish speakers 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 (anterior cruciate ligament) 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 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient and provider intervention<br>participants will receive a patient and provider intervention | Behavioral: patient and provider intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-reported pain, stiffness and function. | Measured by the validated Spanish version of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). | baseline, 6 months and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical function | Short Physical Performance Test Protocol | Baseline and 12 months | 
| Change in Depressive symptoms | Measured with the Spanish version of the Patient Health Questionnaire (PHQ-8). | Baseline and 12 months | 
| Change in weight | measured on a standard scale | Baseline and 12 months | 
| Participants perception of the intervention | Semi structured interviews | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, Hispanic, behavior, intervention, Spanish