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Clinical Trials/NCT05051124
NCT05051124CompletedNot Applicable

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

NYU Langone Health1 site in 1 country101 target enrollmentStarted: April 19, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
101
Locations
1
Primary Endpoint
Absolute Mean Change in Systolic Blood Pressure (SBP)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Patients Enrolled in the AMPATH CDM Program

Experimental

Intervention: Peer Delivery of Medications (Behavioral)

Patients Enrolled in the AMPATH CDM Program

Experimental

Intervention: Health Information Technology (HIT) Platform (Behavioral)

Outcomes

Primary Outcomes

Absolute Mean Change in Systolic Blood Pressure (SBP)

Time Frame: Baseline, Month 12

Pill Count Adherence Ratio

Time Frame: Month 12

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

Number of Peer Completions of HIT Form

Time Frame: Month 12

Number of Confirmed Medication Deliveries

Time Frame: Month 12

Confirmed medication delivery will be documented by patient e-signature.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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