NCT01782417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

January 31, 2013

Last Update Submit

October 11, 2015

Conditions

Osteoarthritis

Keywords

osteoarthritisHispanicbehaviorinterventionSpanish

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Physical function

    Baseline and 12 months

  • Change in Depressive symptoms

    Baseline and 12 months

  • Change in weight

    Baseline and 12 months

  • Participants perception of the intervention

    12 months

Study Arms (1)

Patient and provider intervention

OTHER

participants will receive a patient and provider intervention

Behavioral: patient and provider intervention

Interventions

patient and provider interventionBEHAVIORAL

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.

Patient and provider intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 29997898DERIVED

MeSH Terms

Conditions

OsteoarthritisBehavior

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kelli Allen, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 1, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-06

Locations

US(1)