The PROACTIVE Study for Black Elders (NCT06512727) | Clinical Trial Compass
RecruitingNot Applicable
The PROACTIVE Study for Black Elders
United States120 participantsStarted 2025-05-07
Plain-language 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 culturally congruent pain self-management intervention. A total of 120 persons aged 50-92, self-identifying as Black or African American having CMP will be invited to participate in this study. The primary outcome measured throughout this 3-year study is movement-evoked pain (MEP).
Who can participate
Age range
50 Years – 92 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in movement-evoked pain from baseline to 4 weeks (post-intervention)
. Able to read, write, and understand English at sixth-grade level
Exclusion criteria
. 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)