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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01782417
First received: January 31, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Behavioral: patient and provider intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Self-reported pain, stiffness and function. [ Time Frame: baseline, 6 months and 12 months. ] [ Designated as safety issue: No ]
    Measured by the validated Spanish version of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC).


Secondary Outcome Measures:
  • Change in Physical function [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Short Physical Performance Test Protocol

  • Change in Depressive symptoms [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Measured with the Spanish version of the Patient Health Questionnaire (PHQ-8).

  • Change in weight [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    measured on a standard scale

  • Participants perception of the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Semi structured interviews


Estimated Enrollment: 25
Study Start Date: February 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782417

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Kelli Allen, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01782417     History of Changes
Other Study ID Numbers: Pro00022836_1
Study First Received: January 31, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
osteoarthritis
Hispanic
behavior
intervention
Spanish

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014