The PROACTIVE Study for Black Elders
NCT Number: NCT06512727
Acronym: PROACTIVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Musculoskeletal Pain|Chronic Pain|Osteoarthritis|Pain, Chronic|Movement Evoked Pain
Interventions: BEHAVIORAL: PROACTIVE Intervention
Sponsor: University of Florida
Collaborators: National Institute of Nursing Research (NINR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2027-10

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.

Primary Outcome Measures: 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 Outcome Measures: Pain interference, PROMIS Adult Short Form v1.0- Pain interference 6b, a is a validated, 6-item self-report instrument with strong reliability and validity. Pain interference measures the degree of interference with usual social, work, physical, and emotional functioning. Questions ask people to recall how much pain has interfered social, cognitive, emotional, physical, and recreational activities in the last seven day (1=not at all to 5=very much)., Baseline, Week 4, 1-month, 3-months|Pain coping, Coping Strategies Questionnaire is a valid and reliable survey with six cognitive (diverting attention, reinterpreting pain sensations, coping self-statements, ignoring pain sensations, praying or hoping, and catastrophizing) and one behavioral (increasing activity level) pain coping subscales where 0 (never do) to 6 (always do that when in pain). A score from 0-36 points is calculated for each subscale., Baseline, Week 4, 1-month, 3-months|Physical function- Short Physical Performance Battery, Performance-based activities, such as the Short Physical Performance Battery (SPPB) will evaluate physical function. The SPPB measures standing balance, 4-meter gait speed, and ability to rise from chair. Each task is score 0-4 and total scores range from 0-12, with lower scores indicating greater impairment., Baseline, Week 4, 1-month, 3-months|Physical function- 3-Minute Walk, The 3-minute walk test requires participants to walk continuously for 3 minutes, and it measures endurance and aerobic capacity. Time walked, number of meters walked, and pain intensity (i.e., MEP) will be recorded., Baseline, Week 4, 1-month, 3-months