Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults. (PRIMO-Latino)
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|ClinicalTrials.gov Identifier: NCT01782417|
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : October 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Behavioral: patient and provider intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults.|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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.
- 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).
- Change in Physical function [ Time Frame: Baseline and 12 months ]Short Physical Performance Test Protocol
- Change in Depressive symptoms [ Time Frame: Baseline and 12 months ]Measured with the Spanish version of the Patient Health Questionnaire (PHQ-8).
- Change in weight [ Time Frame: Baseline and 12 months ]measured on a standard scale
- Participants perception of the intervention [ Time Frame: 12 months ]Semi structured interviews
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782417
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Kelli Allen, PhD||Duke University|