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临床试验/NCT05051124
NCT05051124已完成不适用

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

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Absolute Mean Change in Systolic Blood Pressure (SBP)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •Acute illness requiring immediate medical attention
  • •Terminal illness
  • •Inability to provide informed consent

研究组 & 干预措施

Patients Enrolled in the AMPATH CDM Program

Experimental

干预措施: Peer Delivery of Medications (Behavioral)

Patients Enrolled in the AMPATH CDM Program

Experimental

干预措施: Health Information Technology (HIT) Platform (Behavioral)

结局指标

主要结局

Absolute Mean Change in Systolic Blood Pressure (SBP)

时间窗: Baseline, Month 12

Pill Count Adherence Ratio

时间窗: Month 12

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

Number of Peer Completions of HIT Form

时间窗: Month 12

Number of Confirmed Medication Deliveries

时间窗: Month 12

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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