Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800145
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2023-03-22
Brief Title:
Trial to Address Food Insecurity in Patients With Hypertension SMART-FI
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Pilot Study to Evaluate the Feasibility of Using a Sequential Multiple Assignment Randomized Trial to Address Food Insecurity in Patients With Hypertension Pilot SMART-FI
Status:
COMPLETED
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:
SMART-FI
Brief Summary:
In the US 47 of adults have hypertension HTN and HTN accounts for more cardiovascular disease CVD deaths than any other CVD risk factor Thus the lack of an adaptive stepped-care intervention to address FI in patients with HTN is a critical problem affecting a large vulnerable population
Detailed Description:
Despite advances in prevention and treatment barriers to adherence are common and HTN disparities remain pervasive Populations that have been socially and economically disadvantaged have a greater prevalence of HTN worse blood pressure control and are at higher risk of developing CVD from HTN Food insecurity FI the lack of consistent access to nutritionally adequate foods is an important social need that affects 30 million people in the US impacts adherence to treatment and contributes to HTN disparities Increasingly health systems are investing in interventions to address FI as part of routine care including lower-cost low intensity eg providing information about community resources and higher-cost high intensity eg using community health workers CHWs delivery of medical tailored meals MTM interventions
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 |
|---|---|---|---|
| 5K23HL146902-04 | NIH | None | httpsreporternihgovquickSearch5K23HL146902-04 |