The PROACTIVE Study for Black Elders

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06512727
Status
Recruiting
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Conditions

  • Chronic Pain
  • Movement Evoked Pain
  • Musculoskeletal Pain
  • Osteoarthritis
  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
50 Years - 92 Years
Healthy Volunteers
Not accepted

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

Study Details

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).

Key Dates

Start date
May 7, 2025
Status verified
Jun 2026
Primary completion
Aug 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care (Control Group)
    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.
  • Experimental: PROACTIVE
    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.

Primary Outcome Measure

Change in movement-evoked pain from baseline to 4 weeks (post-intervention) [ Time Frame: Baseline, Week 4, 1-month, 3-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Staja Booker, PhD, RN
Staja Booker, PhD, RN (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
University of Florida· Gainesville, FL

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