Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444308
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Community Health Worker-led Hypertension Management
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Assessing the Efficacy and Safety of Community Health Worker-led Hypertension Management Enabled by a Mobile Clinical Decision Support Application Compared to Physician Care a Randomized Controlled Noninferiority Trial
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:
None
Brief Summary:
This study is to determine if hypertension management by community health workers CHW supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure The target population is patients with hypertension in rural Guatemala Study duration will be 12-24 months
Detailed Description:
The investigators have developed an innovative system of care utilizing CHWs equipped with a mobile application and supported and supervised remotely by physicians This model of care is adapted from a CHW-led diabetes program enabled by a similar CDS application which the investigators implemented in the same communities in rural Guatemala where we will carry out this proposed study This program safely led to significant improvements in glycemic control The mobile application is built on the widely-used CommCare platform and provides clinical decision support CDS to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration lifestyle counseling and identification of patients requiring a higher level of care
The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician
The Secondary Objective is to evaluate the safety acceptability to patients and cost of CHW-led care compared to care provided directly by a physician
The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician
The Secondary Objective is to evaluate the safety acceptability to patients and cost of CHW-led care compared to care provided directly by a physician
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 |
|---|---|---|---|
| 4R33TW011891-03 | NIH | UW Madison | httpsreporternihgovquickSearch4R33TW011891-03 |
| A532050 | OTHER | None | None |
| Protocol Version 32924 | OTHER | None | None |