Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512727
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
The PROACTIVE Study for Black Elders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testing the Pain Relief of musculOskeletal Conditions and Arthritis Using Culturally Tailored InterVentions for Black Elders PROACTIVE Intervention A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROACTIVE
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
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 BlackAfrican Americans BAAs 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 BAAs Many BAA 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 faithspirituality Black culture and other underlying potentially modifiable SDoH eg health literacy financial hardship The investigator team propose to enhance older BAAs 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 healthcareinsurance benefits for pain care This study will enroll 120 BAAs 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 BAA 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 BAAs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None