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OpenTrials
Completed

NCT Number: NCT01782417

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patient and provider intervention

Behavioral

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.

Primary outcomes

  1. Change in Self-reported pain, stiffness and function.

    Time frame: baseline, 6 months and 12 months.

    Measured by the validated Spanish version of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC).

Secondary outcomes

  1. Change in Physical function

    Time frame: Baseline and 12 months

    Short Physical Performance Test Protocol

  2. Change in Depressive symptoms

    Time frame: Baseline and 12 months

    Measured with the Spanish version of the Patient Health Questionnaire (PHQ-8).

  3. Change in weight

    Time frame: Baseline and 12 months

    measured on a standard scale

  4. Participants perception of the intervention

    Time frame: 12 months

    Semi structured interviews

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: PRIMO-Latino

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2013
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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