The PROACTIVE Study for Black Elders

NCT06512727 | Recruiting

• 2 other identifiers: IRB2023020851R01NR021183-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Pain, Chronic; Movement Evoked Pain; Musculoskeletal Pain; Chronic Pain; Osteoarthritis

Keywords

chronic musculoskeletal pain; chronic pain; Black; African Americans; pain self-management; prayer; social determinants of health

Outcome Measures

Primary Outcomes (1)

• Change in movement-evoked pain from baseline to 4 weeks (post-intervention)

  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

  Baseline, Week 4, 1-month, 3-months

Secondary Outcomes (4)

• Pain interference

  Baseline, Week 4, 1-month, 3-months

• Pain coping

  Baseline, Week 4, 1-month, 3-months

• Physical function- Short Physical Performance Battery

  Baseline, Week 4, 1-month, 3-months

• Physical function- 3-Minute Walk

  Baseline, Week 4, 1-month, 3-months

Study Arms (2)

Usual Care (Control Group)

NO INTERVENTION

The control group will continue their usual pain treatment and self-management (SM) routines. Participations will not receive in-depth culturally congruent education, prayer skills, or financial counseling. Usual care is expected to vary between participants.

PROACTIVE

EXPERIMENTAL

This is a four-session pain self-management (SM) intervention designed to reduce movement-evoked pain by providing participants with behavioral support that addresses social determinants of health: (1) culturally congruent SM education + SM resource toolkit, (3) active prayer support, and (3) financial counseling.

Behavioral: PROACTIVE Intervention

Interventions

PROACTIVE Intervention BEHAVIORAL

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

Also known as: FAITH (Finding Arthritis Interventions That Help)

PROACTIVE

Eligibility Criteria

• Age: 50 Years - 92 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Staja Q Booker, PhD, RN

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Staja Q Booker, PhD, RN

CONTACT

352-273-6351; bookers@ufl.edu

Fern Webb, PhD

CONTACT

904-244-9859; fern.webb@jax.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: May 7, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After the study is complete, the study team will submit all remaining scientific data to the data repository and will update the randomized controlled trial status to "complete" in clinicaltrials.gov. Scientific data will be made available to other users approximately 12 months following the final data collection point or within the award period (or NCE) if requested, and remain available for an indefinite time or for as long as it is scientifically useful for the research community, institutions, and/or the broader public.
• Access Criteria: Researchers requesting data directly from the PI will need to complete a "Data Sharing and Use Agreement" prior to release of data. The requesting institution's Institutional Review Board or equivalent body must approve the requested use or provide documentation of exemption before data will be shared.

Locations

US (1)