Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485700
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Peers and Technology for Adherence Access Accountability and Analytics PT4A
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Peers and Technology for Adherence Access Accountability and Analytics PT4A
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PT4A
Brief Summary:
Peer-based medication delivery decreases the cost of transportation and the opportunity cost of travel while HIT can support peer activities by facilitating targeted adherence counseling teleconsultation synchronization of clinical care and pharmacy activities The investigators have implemented a pilot program of door-to-door peer-based medication delivery and HIT in western Kenya and preliminary data indicate improved adherence and blood pressure However the effectiveness of this implementation strategy is not fully established Therefore the objective of the study is to use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research to test the hypothesis that integrating peer delivery of medications with HIT PT4A improves medication adherence and reduces blood pressure among patients with uncontrolled hypertension in western Kenya
Detailed Description:
Aim 1 will evaluate the effectiveness of PT4A by conducting a two-arm cluster randomized controlled implementation research hybrid type 2 trial comparing PT4A to control The primary biological outcome is one-year change in systolic blood pressure The primary adherence outcome is the pill count adherence ratio The primary implementation outcome is fidelity Secondary outcomes are blood pressure control self-reported adherence and RE-AIM metrics Aim 2 will evaluate potential mechanistic relationships between implementation measures and outcomes Sub Aim 21 will evaluate if trust in the health system and patient activation mediate the relationship between PT4A and the outcomes Aim 3 will consist of cost-effectiveness budget impact and qualitative analyses to help inform adaptation of PT4A to other settings The research will be conducted by a transdisciplinary team with diverse and complementary expertise The investigators intend to add to existing knowledge of innovative and scalable strategies to improve medication adherence for global hypertension control
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