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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Peer Delivery of Medications
  Door-to-door peer delivery of medications within patients' communities will be implemented.
• Другое Health Information Technology (HIT) Platform
  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.

Первичные конечные точки

• Mean Change in SBP from Baseline to Month 12 [Срок оценки: Baseline, Month 12]
• Pill Count Adherence Ratio (PCAR) at Month 12 [Срок оценки: Month 12]
• Number of Patient E-Signatures [Срок оценки: Up to Month 12]
• Number of Completed HIT Forms [Срок оценки: Up to Month 12]

Вторичные конечные точки (3)

• Mean Change in SBP from Baseline to Month 6 [Срок оценки: Baseline, Month 6]
• Percentage of Participants with Controlled Blood Pressure (BP) at Month 6 [Срок оценки: Month 6]
• Percentage of Participants with Controlled BP at Month 12 [Срок оценки: Month 12]

Критерии участия

Критерии включения

• Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90)

Критерии исключения

• hypertensive emergency requiring immediate medical attention,
• terminal illness, and
• inability to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Kenya · 3 центра

• Study Site — Webuye
• Study Site — Kitale
• Study Site — Eldoret

Идентификаторы

NCT: NCT06485700 · 24-00277

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗