The PROACTIVE Study for Black Elders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-92
SponsorUniversity of Florida
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
PROACTIVE Intervention
BehavioralDuration: 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Usual Care (Control Group)No intervention 0 interventions
Group B: PROACTIVEExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Baseline, Week 4, 1-month, 3-monthsSecondary outcomes
1
Pain interference
PROMIS (Patient-Reported Outcomes Measurement Information System) 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).
Time frame
Baseline, Week 4, 1-month, 3-months2
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.
Time frame
Baseline, Week 4, 1-month, 3-months3
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.
Time frame
Baseline, Week 4, 1-month, 3-months4
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.
Time frame
Baseline, Week 4, 1-month, 3-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov