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PT4A: Peers and Technology for Adherence, Access, Accountability, and Analytics

Sponsor
NYU Langone Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05051124
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
30
Enrollment
1
Location
1
Arm
4.4
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall objective of this project is to utilize the PRECEDE-PROCEED framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. The central hypothesis is that peer delivery of medications integrated with HIT (PT4A) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western Kenya. This application will focus on the critical formative components of the overall implementation research objective. This study record will focus on Sub-Aim 2.2: a pilot of the intervention and focus group discussions with patients, peers, and clinical staff will be conducted to evaluate feasibility. The study team will also evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Delivery of Medications
  • Behavioral: Health Information Technology (HIT) Platform
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - A Qualitative Study
Actual Study Start Date :
Apr 19, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sub-Aim 2.2 Participants

Behavioral: Peer Delivery of Medications
The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities

Behavioral: Health Information Technology (HIT) Platform
To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.

Outcome Measures

Primary Outcome Measures

  1. Absolute Mean Change in Systolic Blood Pressure (SBP) [Baseline, Month 3]

  2. Change in pill count adherence ratio [Baseline, Month 3]

    Proportion of prescribed doses taken over a 1-month time period

  3. Number of confirmed medication deliveries [Month 3]

    Confirmed medication delivery will be documented by patient e-signature

  4. Number of peer completions of the HIT form [Month 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult patients ≥ 18 years old

  • Enrolled in the AMPATH CDM PRogram

  • Have uncontrolled hypertension (defined as systolic blood pressures ≥ 140 or diastolic blood pressure ≥ 90)

Exclusion Criteria:

  • Acute illness requiring immediate medical attention

  • Terminal illness

  • Inability to provide informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Rajesh Vedanthan, MD, MPH, NYU Langone Health

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05051124
Other Study ID Numbers:
  • 20-01579
  • 1R56HL150036
First Posted:
Sep 21, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Aug 18, 2022