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Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)

Primary Purpose

Hypertension, Medication Adherence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Delivery of Medications
Health Information Technology (HIT) Platform
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients Enrolled in the AMPATH CDM Program

Arm Description

Outcomes

Primary Outcome Measures

Absolute Mean Change in Systolic Blood Pressure (SBP)
Pill Count Adherence Ratio
Proportion of prescribed doses taken over a 1-month time period.
Number of Confirmed Medication Deliveries
Confirmed medication delivery will be documented by patient e-signature.
Number of Peer Completions of HIT Form

Secondary Outcome Measures

Full Information

First Posted
September 10, 2021
Last Updated
January 18, 2023
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05051124
Brief Title
Peers and Technology for Adherence, Access, Accountability, and Analytics
Acronym
PT4A
Official Title
PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - A Qualitative Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 study record will focus on Sub-Aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. The investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. The investigators will also create a retrospective comparator (control) group of CDM patients, through querying AMRS, matched by sex, age, location and initial blood pressure level. The investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the PT4A program to help understand the magnitude and variance of the intervention effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Medication Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients Enrolled in the AMPATH CDM Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Peer Delivery of Medications
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Health Information Technology (HIT) Platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Absolute Mean Change in Systolic Blood Pressure (SBP)
Time Frame
Baseline, Month 12
Title
Pill Count Adherence Ratio
Description
Proportion of prescribed doses taken over a 1-month time period.
Time Frame
Month 12
Title
Number of Confirmed Medication Deliveries
Description
Confirmed medication delivery will be documented by patient e-signature.
Time Frame
Month 12
Title
Number of Peer Completions of HIT Form
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajesh Vedanthan, MD, MPH
Phone
646-501-3890
Email
rajesh.vedanthan@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Gjonaj
Phone
646-501-3663
Email
Jessica.gjonaj@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Vedanthan, MD, MPH
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajesh Vedanthan, MD, MPH
Phone
646-501-3890
Email
rajesh.vedanthan@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose will have access to the data upon reasonable request. Requests should be directed to rajesh.vedanthan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

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

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