Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults. (PRIMO-Latino)

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Behavioral: patient and provider intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient and provider intervention; participants will receive a patient and provider intervention	Behavioral: patient and provider intervention; 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	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kelli Allen, PhD, Duke University

Publications and helpful links

General Publications

• Corsino L, Coffman CJ, Stanwyck C, Oddone EZ, Bosworth HB, Chatterjee R, Jeffreys AS, Dolor RJ, Allen KD. A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino). Pilot Feasibility Stud. 2018 Jul 4;4:89. doi: 10.1186/s40814-018-0280-x. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 11, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: osteoarthritis; behavior; intervention; Spanish; Hispanic
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Pro00022836_1