跳至主要内容
临床试验/NCT05955937
NCT05955937进行中(未招募)不适用

ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda

Yale University14 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2025年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
576
试验地点
14
主要终点
Clinical Effectiveness

研究概览

简要总结

This is a stepped wedge, cluster-randomized study, that will implement a digital-first, multi-component strategy for Heart Failure (HF) to improve HF self-care at 6 Regional Referral Hospital (RRH) outpatient departments in Uganda. The investigators will evaluate both implementation and clinical outcomes using mixed methods. . First, investigators will assess the implementation and clinical effectiveness of an enhanced standard-of-care clinical bundle, and a digital health intervention to improve HF self-care in Uganda (Aim 1). To do this, the investigators will conduct a stepped-wedge, cluster randomized trial that includes a brief control period followed by a clinical care service bundle for HF (Core HF), followed by the introduction of the digital health application (Medly Uganda). The co-primary outcomes will be the Self-Care of HF Index (implementation) and the composite of mortality and HF hospitalization (clinical effectiveness).

To ensure standardized basic HF care which will augment self-care, investigators will train providers in an evidence-based HF clinical care service bundle (Core HF) including a care protocol (treatment algorithm for HF), self-care training for patients and providers, and medication stock management prior to the introduction of the digital health intervention (Medly Uganda). Medly Uganda will utilize a patient-facing mobile health application designed to improve self-care among patients with HF. Its principal components are: 1) a patient-facing mobile application that processes patient-reported symptoms and generates algorithm-driven messages to guide self-care and symptom management and 2) a clinician-facing internet dashboard that monitors symptom reports and facilitates nurse-guided management recommendations and physician backup support. The project supports an integrated, digital interface at participating hospitals to monitor and intervene with patients using the mobile health application.

详细描述

In parallel to the above, the investigators will conduct a mixed methods process evaluation to inform iterative adjustments to the implementation processes, i.e., a Learn- As-You-Go design by reviewing qualitative feedback and quantitative intervention data (Aim 2). Then, cost effectiveness, and sustainability factors for Medly Uganda, including an examination of cost, cost-effectiveness, and equity of Medly Uganda from a financial and societal perspective will be explored (Aim 3).

The focus of this registration will be Aim 1 and Aim 2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Clinical diagnosis of New York Heart Association (NYHA) Class II-III HF
  • Access to a mobile phone
  • Basic reading skills in 1 of the offered languages, as determined by their clinical care provider. Languages will include: Lugbara in Arua, Lugiso in Mbale, Runyankole in Mbarara, Luganda in Masaka, Rutooro in Fort Portal, and Langi in Lira in addition to English.

排除标准

  • Any individual not meeting the above inclusion criteria
  • Inability to provide informed consent, as determined by the nurse manager
  • Active medical condition requiring hospitalization, such as cardiac ischemia (acute electrocardiographic changes and/or positive biomarkers, if available), syncope, or significant fluid overload
  • Echocardiography findings that do not support a diagnosis of HF as determined during a study visit. This exclusion might occur following enrollment and new patients may be consented and enrolled to compensate for these exclusions.

研究组 & 干预措施

Step 2. Core-HF plus Medly Uganda digital health intervention

Experimental

Medly Uganda will utilize a patient-facing mobile health application designed to improve self-care among patients with HF. Its principal components are: 1) a patient-facing mobile application that processes patient-reported symptoms and generates algorithm-driven messages to guide self-care and symptom management and 2) a clinician- facing internet dashboard that monitors symptom reports and facilitates nurse-guided management recommendations and physician backup support. The project will support an integrated, digital interface at participating hospitals to monitor and intervene with patients who are using the mobile health application.

干预措施: Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF) (Other)

Step 1. Core HF intervention period

Experimental

All sites will be trained in an evidence-based clinical care bundle for HF, to ensure standardized basic HF care across the participating RRHs in the study. For this service bundle which will augment self-care (Core-HF), the investigators will train providers in an evidence-based HF clinical care service bundle including a care protocol (treatment algorithm for HF), self-care training for patients and providers, and medication stock management prior to introducing the digital health intervention (Medly Uganda, described in Arm 2).

干预措施: Enhanced HF Clinical Care (Core-HF) (Other)

结局指标

主要结局

Clinical Effectiveness

时间窗: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

A composite of the number of participants with mortality and HF hospitalization will be used to assess clinical effectiveness. This outcome is the most widely used composite clinical endpoint in HF trials globally.

Change in Self-Care of Heart Failure Index (SCHFI)

时间窗: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

The SCHFI v7.23 is a validated 39-item instrument hat assesses maintenance, management, and self-confidence of heart failure self-care. Scores range from 0-100 with higher scores indicating improved self care.

次要结局

  • Participant fidelity to self-care assessed by medication adherence using Medication Adherence Report Scale (MARS-5) and 7-day recall(up to 36 months)
  • Change in NYHF Classification(up to 36 months)
  • Change in 6-minute walk test(baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
  • Change in Pro-NT Brain Natriuretic Peptide (Pro-NT BNP)(baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)(baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
  • Change in EuroQol -5D (EQ-5D)(baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
  • Facility fidelity to implementation strategy assessed by vital sign checks and other intervention components(up to 36 months)
  • Facility fidelity to implementation strategy assessed by the availability of medications(up to 36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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