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

Hypertension Clinical Trial

— PT4A  

Official title:

PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - A Qualitative Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05051124
• Other study ID #: 20-01579
• Secondary ID: 1R56HL150036
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Mean Change in Systolic Blood Pressure (SBP)		Baseline, Month 12
Primary	Pill Count Adherence Ratio	Proportion of prescribed doses taken over a 1-month time period.	Month 12
Primary	Number of Confirmed Medication Deliveries	Confirmed medication delivery will be documented by patient e-signature.	Month 12
Primary	Number of Peer Completions of HIT Form		Month 12