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Principal Investigator: Joseph Antony Cafazzo
Organization: YALE UNIVERSITY
Fiscal Year: 2024
Award: $542,296
Funding agency: National Heart Lung and Blood Institute
PROJECT SUMMARY/ABSTRACT
In sub-Saharan Africa, heart failure (HF), a clinical syndrome that causes multiple debilitating symptoms and
results in poor health-related quality of life, has a 34% 1-year mortality rate, the highest of any region globally.
Major care gaps and sociodemographic disparities exist throughout the continuum of HF care. Self-care is an
evidence-based intervention that can improve clinical and patient-reported outcomes in HF and is widely
endorsed by international bodies. Self-care holds particular promise in low- and middle-income countries (LMIC)
because it shifts fundamental care tasks from providers and facilities to patients while empowering patients to
better care for themselves. However, self-care is underutilized in LMIC where providers lack knowledge, tools,
and time to support patients in self-care and where inequities in self-care implementation among patients and
providers are not well known. The overarching goal of our work is to improve HF care in LMIC. In this Type 2
hybrid study, we will implement a digital-first strategy (Medly Uganda) to improve self-care in HF at 6 Ugandan
Regional Referral Hospital outpatient departments and evaluate both implementation and clinical outcomes. All
study aims are guided by the RE-AIM framework and PRISM extension, involve mixed methods, and are
designed to prioritize health equity. First, we will assess the implementation and clinical effectiveness of Medly
Uganda to improve HF self-care in Uganda (Aim 1). To do this, we will conduct a stepped-wedge, cluster
randomized trial that includes a control period followed by a basic evidence-based package to support HF care,
followed by 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). In parallel to this, we will conduct a mixed
methods process evaluation to inform iterative adjustments to the implementation processes (Sub-Aim 1.1) using
a community-engaged approach to systematically collect qualitative and quantitative process data at pre-
determined time points based on the Learn-As-You-Go design and make contextually appropriate
implementation adaptations. Next, we will evaluate the implementation fidelity and context of Medly Uganda with
a focus on reach, adoption, and maintenance (Aim 2) using a deviance approach based on Medly Uganda meta
data from patients and providers, focusing on how social determinants might shape equity in implementation.
We will also explore patient and provider impacts beyond HF, such as mental health and healthcare autonomy.
Then, we will explore cost, cost effectiveness, and sustainability factors for Medly Uganda (Aim 3), including an
examination of cost, cost-effectiveness, and equity of Medly Uganda from a financial and societal perspective
(Sub-Aim 3.1) and an exploration of patient and provider perspectives on the sustainability of Medly Uganda
(Sub-Aim 3.2). This study will generate important insights to support implementation of innovative, locally
relevant strategies to improve HF care in LMIC and aligns with NHLBI's Center for Translation Research and
Implementation Science priorities.
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