Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353256
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-28
Brief Title:
A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Alabama Womb 2 Heart Solution AW2H A Community Health Worker Intervention to Improve Short- and Long-term Outcomes in Black Patients With Adverse Pregnancy Outcomes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AW2H
Brief Summary:
United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial regional and socioeconomic disparities in access to care and overall health The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia PE and other adverse pregnancy outcomes APOs Investigators will partner with a community-based organization that trains and deploys community health workers Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1 enhance blood pressure control postpartum and 2 promote long-term cardiovascular disease prevention for this underserved population This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants
Detailed Description:
The investigators will adapt a current perinatal community health worker intervention lead by a leading community health worker organization Connection Health to the unique needs of Black postpartum patients with preeclampsia and other adverse pregnancy outcomes The investigators will conduct a pilot trial to assess the feasibility and acceptability of the intervention The hypothesis is that it is possible to randomize eligible patients to the feasibility trial and the intervention will be acceptable to participants The investigators will randomize Black postpartum patients with preeclampsia or other adverse pregnancy outcomes to either 1 usual care - cardiovascular disease-prevention education before discharge or 2 intervention - cardiovascular disease prevention education before discharge plus an adapted Connection Health community health worker intervention Following the completion of this project the investigators intend to conduct a larger postpartum community health worker intervention trial in patients with preeclampsia or other adverse pregnancy outcomes powered to detect a difference in clinically meaningful outcomes as informed by our existing community advisory board
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR003096 | NIH | None | None |
| 24POST1198805 | OTHER_GRANT | American Heart Association | httpsreporternihgovquickSearchUL1TR003096 |