Clinical trial NCT06512727: The PROACTIVE Study for Black Elders
Official title: Testing the Pain Relief of musculOskeletal Conditions and Arthritis Using Culturally Tailored InterVentions for Black Elders (PROACTIVE) Intervention: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Chronic Pain
Osteoarthritis
Pain, Chronic
Movement Evoked Pain
Keywords: chronic musculoskeletal pain
chronic pain
Black
African Americans
pain self-management
prayer
social determinants of health
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 (MEP).

Detailed description: Chronic musculoskeletal conditions and their primary source of pain, movement-evoked pain (MEP), causes significant pain interference, long-term mobility impairment, healthcare costs, and psychosocial inequalities. MEP affects more Black/African Americans (B/AAs) and is reported as more severe than in White participants. Compounded by race, age, and more disadvantageous social determinants of health (SDoH), this unequal burden of pain becomes even greater in health disparity populations like older B/AAs. Many B/AA older adults rely on non-pharmacological pain self-management (SM) strategies. Yet, current chronic musculoskeletal pain (CMP) SM interventions do not measure MEP as a primary endpoint nor address faith/spirituality, Black culture, and other underlying potentially modifiable SDoH (e.g., health literacy, financial hardship). The investigator team propose to enhance older B/AAs' capacity to manage MEP by investigating the effects of a socioculturally congruent pain SM intervention (Pain Relief for musculOskeletal conditions and Arthritis using Culturally-Tailored InterVentions for Black Elders \[PROACTIVE\]). This intervention will provide culturally congruent pain SM education with a SM resource toolkit, active prayer skills, and financial counseling to explain participants' healthcare/insurance benefits for pain care. This study will enroll 120 B/AAs (50 years and older) with CMP into a parallel group, single-blind, randomized controlled trial to test whether PROACTIVE decreases MEP in the immediate post-intervention period (n= 60) (Aim 1) and over time (Sub-Aim 1a) compared to a usual care control group (n= 60). To determine efficacy, this study will use state-of-the-art and real-time technologies to measure primary outcome as well as pain interference, pain coping, and physical function (secondary outcomes) (Sub-Aim 1b). The PROACTIVE group will work with a faith-community nurse and financial counselor over four weeks to enhance knowledge of CMP SM, utilization of active prayer and faith, and financial literacy of health insurance benefits and resources available to cover treatments for pain. Each weekly session will last up to 2 hours and will be followed by six days of ecological momentary assessments of pain and SM outcomes and ecological momentary interventions guiding participants through weekly SM practice skills. A fourth booster session will reinforce content and training and help sustain SM. Another goal is to examine the differential effects of PROACTIVE on MEP according to demographic (sex as a biological variable, gender, age), psychosocial, and SDoH factors (Aim 2). The proposed intervention is expected to produce meaningful reductions in MEP in B/AA older adults experiencing disabling chronic musculoskeletal conditions. Ideally, this study will identify precision behavior targets and responders to inform intervention refinement. This study is innovative because it: (1) addresses three key social determinants of health central to B/AAs' pain experience- health literacy, faith, and finances, (2) embeds community-engaged research methodologies, (3) tests active prayer as a novel faith-based, culturally relevant intervention, (4) uses real-time ecological momentary assessment (EMA) to measure pain and related outcomes and use just-in-time ecological momentary interventions (EMI) to deliver pain SM decision support and active prayers, and (5) measures MEP as a primary endpoint in a clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean)
2. Age 50-92 years
3. 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)
4. 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)
5. Report chronic musculoskeletal symptoms: aching, stiffness, or swelling in a major lower extremity joint or low back on most days (4-5/7) of the week
6. Have (or be eligible for) a healthcare insurance plan in the state of Florida (Medicare, Medicaid, Medicare Advantage plans, Blue Cross/Blue Shield, Humana, Aetna, etc.)
7. Able to read, write, and understand English at sixth-grade level

Exclusion Criteria:

1. Unwilling to be randomized to either study arm
2. Self-reported diagnosis of sickle cell disease or related thalassemias
3. History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
4. 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)
5. Currently undergoing curative or palliative chemotherapy or radiation for active cancer
6. Severe physical impairment (e.g., a major activity of daily living disability requiring use of wheelchair as primary method of mobility, or unable to dress, bath, use the toilet, or transfer independently)
7. Serious mental health disorder requiring hospitalization within past 12 months
8. Severe sensory deficit (severe hearing loss or blindness)

Primary outcomes:
measure: Change in movement-evoked pain from baseline to 4 weeks (post-intervention)
timeFrame: Baseline, Week 4, 1-month, 3-months
Secondary outcomes:
measure: Pain interference
timeFrame: Baseline, Week 4, 1-month, 3-months
measure: Pain coping
timeFrame: Baseline, Week 4, 1-month, 3-months
measure: Physical function- Short Physical Performance Battery
timeFrame: Baseline, Week 4, 1-month, 3-months
measure: Physical function- 3-Minute Walk
timeFrame: Baseline, Week 4, 1-month, 3-months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Staja Q Booker, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: