Cardiovascular Disease, Hypertension
Conditions
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 2.1 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.
Interventions
Door-to-door peer delivery of medications within patients' communities will be implemented.
The HIT platform provides: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) medication refill tracking to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90)
Exclusion criteria
* hypertensive emergency requiring immediate medical attention, * terminal illness, and * inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in SBP from Baseline to Month 12 | Baseline, Month 12 | — |
| Pill Count Adherence Ratio (PCAR) at Month 12 | Month 12 | PCAR is calculated as the percentage of pills taken over the previous month and is measured over a 30-day time period. |
| Number of Patient E-Signatures | Up to Month 12 | Measure of fidelity. |
| Number of Completed HIT Forms | Up to Month 12 | Measure of fidelity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in SBP from Baseline to Month 6 | Baseline, Month 6 | — |
| Percentage of Participants with Controlled Blood Pressure (BP) at Month 6 | Month 6 | BP measured using automatic BP monitor. |
| Percentage of Participants with Controlled BP at Month 12 | Month 12 | BP measured using automatic BP monitor. |
Countries
Kenya
Contacts
CONTACTRajesh Vedanthan
CONTACTJessica Gjonaj
PRINCIPAL_INVESTIGATORRajesh Vedanthan
NYU Langone Health
Outcome results
None listed