PROACTIVE
Testing the Pain Relief of musculOskeletal Conditions and Arthritis Using Carefully Tailored InterVEntions (PROACTIVE) Intervention: A Randomized Controlled Trial
Sponsor study identifier
Secondary identifiers
interventional
120
1 country
1
Study Start
May 7, 2025
Actual (reported)Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 8, 2024
Actual (reported)July 22, 2024
Actual (reported)May 7, 2025
Actual (reported)August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Pain interference
Baseline, Week 4, 1-month, 3-months
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.
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Florida
Gainesville, Florida, 32610, United States
Staja Q Booker, PhD, RN
University of Florida
First Submitted
July 8, 2024
First Posted
July 22, 2024
Study Start
May 7, 2025
Actual (reported)Primary Completion
August 1, 2027
EstimatedImproving Health for Older Adults With Pain Through Engagement
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
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 4, 2026
Record last verified: 2026-06
Public Use Data: All deidentified study data that are not designated as restricted use will be made available as public use data to the research community. Users of public data must agree to terms of use from Mendeley Data repository and the PI, which are designed to protect study participants. Data users also agree not to share or redistribute any data downloads. The dataset can only be used for studying health or biomedical conditions. Restricted Access Data: Data that are determined to be potentially identifiable through indirect or deductive disclosure are provided under restricted data contract to users who demonstrate a valid research need and meet conditions of use. These restricted data will include separate files with geospatial indicators below the level of state, such as county, census tract, block-group, and block for all years; and linkages to contextual social determinants of health data.
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Source: ClinicalTrials.gov.
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