RCT of a Remote Self-management Program (TEAM-Red) for Young Depressed African American Women at Risk for Hypertension
Description: We are proposing an innovative approach to reduce hypertension (HTN) risk among individuals who have been underserved in healthcare, African American (AA) women with depression. By targeting both cardiovascular risk and depression, this self-management intervention aims to empower women and help reduce health disparities. Self-management enables individuals to problem-solve, practice healthy behaviors, and gain emotional stability. This approach may be particularly helpful for young depressed AA women at risk for HTN if presented in an accessible (remote delivery) and supportive manner. There are currently no widely-used and practical approaches specific to AA women that can help prevent cardiovascular risk and AA women with depression critically need such a program. The proposed project is a pilot randomized Phase 2 clinical trial comparing Nurse and Peer Educator Led Self-Management (the “TEAM Red” intervention) with an Enhanced Waitlist (eWL) control in depressed young AA women at risk for hypertension. The self-management curriculum has been tested in multiple populations and shown to reduce both depression and blood pressure (BP). Relevant elements from the original curriculum will be adapted for use with young depressed AA women based on input from our consultants with expertise in women’s health, behavioral medicine, and racial inequities in healthcare delivery and our Peer Educators with lived experience. Those randomized to eWL will crossover and receive the TEAM Red intervention following the 12-week assessment. All potential participants will register in the Research Goes Red Registry at screening. The primary health outcome comparison between TEAM-Red vs eWL will be change in depression as measured by change in PHQ-9 scores from baseline to 12-weeks. Secondary measures indicative of cardiovascular risk will include BP. Mechanistic constructs of the self-management process will be assessed with measures of HTN knowledge, self-efficacy for health behaviors and perceived social support. Proximal behavioral outcomes include health behaviors known to be important to HTN risk reduction including diet, exercise, reduction of substances, and perceived stress and will be measured using validated measures for each of these constructs. Study data will be analyzed using the Precision Medicine platform. If TEAM-Red is shown to improve health outcomes, it has potential to be a practical and effective way to reduce health disparities among AA women.
Funder: American Heart Association
Amount: $444,500
Funding type: research
Funder scheme: Institute - Health Related Social Needs
Start date: 2022-07-01
End date: 2024-06-30
Investigators: Jennifer Levin, Jennifer Levin
Institution: University Hospitals Cleveland Medical Center
Funded outputs count: 2
Funder award ID: 978891
OpenAlex ID: G5701620719