NCT06512727 · University of Florida
The PROACTIVE Study for Black Elders
(PROACTIVE)
What this study is about
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.
View original scientific description
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).
Interventions
BEHAVIORAL
PROACTIVE Intervention
Duration: Once-weekly face-to-face sessions Session Time: 1.5-2 hours Intervention: (1) culturally congruent self-management (SM) education and + SM resource toolkit, (3) active prayer support, and (3) financial counseling/insurance navigation Reinforcement: daily ecological momentary intervention support using Apple smartwatches
Primary outcome measures
Change in movement-evoked pain from baseline to 4 weeks (post-intervention)
Time frame: Baseline, Week 4, 1-month, 3-months
Defense and Veterans Pain Rating Scale (DVPRS) is a validated, self-reported and preferred pain scale for assessing pain intensity and its impact on activities. Possible scores range from 0 (no pain) to 10 (as bad as it could be). Movement-evoked pain (MEP) intensity during the Short Physical Performance Battery (SPPB), a physical performance test that evaluates lower extremity functioning by assessing: standing balancing, gait speed, and repeated chair stand ability. Change: 1. Week 4 score - Baseline score 2. 1 month score - Baseline score 3. 3-months score - Baseline score
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.)
- 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)
Where
- Gainesville, Florida
Collaborators
National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations