Status:
RECRUITING
The PROACTIVE Study for Black Elders
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Musculoskeletal Pain
Chronic Pain
Eligibility:
All Genders
50-92 years
Phase:
NA
Brief Summary
Chronic musculoskeletal pain (CMP), while a leading cause of physical disablement, is a neglected national health disparity issue in Black communities. The purpose of this study is to test a novel cul...
Detailed Description
Chronic musculoskeletal conditions and their primary source of pain, movement-evoked pain (MEP), causes significant pain interference, long-term mobility impairment, healthcare costs, and psychosocial...
Eligibility Criteria
Inclusion
- Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean)
- Age 50-92 years
- Self-report chronic musculoskeletal pain (CMP) as defined as persistent or recurrent pain lasting 6 months or longer that arises as part of a disease or injurious process directly affecting bone(s), joint(s), muscle(s), or related soft tissue(s)
- Self-report a chronic musculoskeletal condition (e.g., osteoarthritis, chronic low back pain) in at least one lower extremity joint (hip, knee, low back, or ankle pain)
- Report chronic musculoskeletal symptoms: aching, stiffness, or swelling in a major lower extremity joint or low back on most days (4-5/7) of the week
- Have (or be eligible for) a healthcare insurance plan in the state of Florida (Medicare, Medicaid, Medicare Advantage plans, Blue Cross/Blue Shield, Humana, Aetna, etc.)
- Able to read, write, and understand English at sixth-grade level
Exclusion
- Unwilling to be randomized to either study arm
- Self-reported diagnosis of sickle cell disease or related thalassemias
- History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
- Major cardiovascular problem in the past 6 months that would cause shortness of breath and/or chest pain (e.g. myocardial infarction, coronary artery bypass graft, or valve replacement, pulmonary embolism or deep venous thrombosis) or uncontrolled Hypertension (Systolic Blood Pressure (SBP) \> 170 mmHg, Diastolic Blood Pressure (DBP) \> 90 mmHg) OR Hypotension (SBP \<90 mmHg, DBP \<60 mmHg)
- Currently undergoing curative or palliative chemotherapy or radiation for active cancer
- Severe physical impairment (e.g., a major activity of daily living disability requiring use of wheelchair as primary method of mobility, or unable to dress, bath, use the toilet, or transfer independently)
- Serious mental health disorder requiring hospitalization within past 12 months
- Severe sensory deficit (severe hearing loss or blindness)
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06512727
Start Date
May 7 2025
End Date
October 1 2027
Last Update
May 9 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610