PROACTIVE Intervention for Chronic Pain

(PROACTIVE Trial)

Overseen By Staja Q Booker, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Sickle cell, Neurological, Cardiovascular, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Staja Q Booker, PhD, RN

Principal Investigator

University of Florida

Eligibility Criteria

The PROACTIVE Study is for Black or African American elders aged 50-92 with chronic musculoskeletal pain, particularly in lower extremity joints. Participants must have health insurance in Florida and be able to understand English at a sixth-grade level.

Inclusion Criteria

I identify as part of the Black American diaspora.

I can read and understand English like a sixth grader.

I am between 50 and 92 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a culturally congruent pain self-management intervention over four weeks, including education, active prayer, and financial counseling

4 weeks

4 weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-month and 3-months post-intervention

3 months

2 follow-up assessments (in-person or virtual)

Treatment Details

Interventions

• PROACTIVE Intervention

Trial Overview This study tests a culturally tailored pain self-management intervention called the PROACTIVE Intervention, designed to address chronic musculoskeletal pain among Black elders. The main focus is on reducing movement-evoked pain over three years.

Participant Groups

Group I: PROACTIVE Experimental Treatment 1 Intervention

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.

Group II: Usual Care (Control Group) Active Control 1 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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+