Key result
Baseline MEDLY Uganda cohort reveals medication nonadherence in ~54% of outpatient heart failure patients.
Why the study?
Prior prospective African HF cohorts largely focused on hospitalized populations and relied on clinical diagnostic criteria, with few employing biomarker- and echo-confirmed HF definitions, longitudinal follow-up across decentralized sites, or implementation science frameworks.
Does sequential implementation of a clinical care improvement bundle (Core-HF) and a digital health bundle (Medly Uganda) reduce the composite of heart failure hospitalization and all-cause mortality and improve the Self-Care in Heart Failure Index in adults with NYHA Class II or III heart failure in Uganda?
RCT (n=547)
Stepped-wedge cluster randomized
Yes
Does sequential implementation of a clinical care improvement bundle (Core-HF) and a digital health bundle (Medly Uganda) reduce the composite of heart failure hospitalization and all-cause mortality and improve the Self-Care in Heart Failure Index in adults with NYHA Class II or III heart failure in Uganda?
Baseline findings from the MEDLY Uganda trial characterize a biomarker-confirmed, predominantly female and rural outpatient heart failure cohort in regional Uganda with high rates of medication non-adherence, highlighting substantial opportunities to improve guideline-directed care.
Background Heart failure (HF) in sub-Saharan Africa is associated with poor outcomes. Prior prospective African HF cohorts have largely focused on hospitalized populations and relied primarily on clinical diagnostic criteria. Few studies have employed biomarker- and echo-confirmed HF definitions, longitudinal follow-up across decentralized sites, or implementation science frameworks to improve care delivery. ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda) is a stepped-wedge cluster randomized type 2 hybrid effectiveness-implementation trial conducted at six regional referral hospitals (RRHs) in Uganda. Following baseline, sequential implementation strategies include a clinical care improvement bundle (“Core-HF”) and Core-HF plus a patient- and clinician-facing digital health bundle (“Medly Uganda”). Primary outcomes are composite of HF hospitalization and all-cause mortality (clinical) and Self-Care in Heart Failure Index (implementation). Purpose To describe the baseline demographic, clinical, biomarker, and treatment characteristics of participants enrolled in MEDLY Uganda. Methods We recruited adults (≥18 years) with suspected New York Heart Association (NYHA) Class II or III HF based on clinical (Framingham) criteria at six RRH outpatient departments. Participants with NT-proBNP <125 pg/mL were excluded unless ejection fraction (EF) was <50%. Baseline assessments included sociodemographics, comorbidities, NYHA class, medication use, echocardiography, NT-proBNP, healthcare expenditures, and self-care and quality-of-life measures. Descriptive statistics were used to characterize the cohort. Results 547 (92%) of a target sample size of 596 participants have been enrolled. 351 (64%) are female and the mean age is 57 (+/-18) years. 321 (59%) are rural-dwelling, 331 (61%) are married, 365 (67%) are unemployed, and the highest education level for 278 (51%) was primary school. 360 (66%), 44 (8%), and 65 (12%) had been diagnosed with hypertension, diabetes, or hyperlipidemia, respectively. Mean body mass index was 26 kg/m2 and waist-to-hip ratio is 0.93 (+/-0.2). Mean systolic and diastolic blood pressure were 121 (+/-26) and 81 (+/-16) mmHg, respectively. 370 (67%) and 176 (32%) were NYHA Class II and III, respectively. Mean NT-proBNP was 5267pg/mL (range 125-35,000). 293 (54%) reported taking medication less frequently than prescribed. Conclusion Participants enrolled in MEDLY Uganda represent a rigorously-phenotyped, biomarker-confirmed, geographically disparate outpatient HF population in Uganda. This study uniquely combines objective diagnostic criteria with a longitudinal stepped-wedge cluster randomized hybrid implementation design evaluating sequential health system interventions. Baseline findings highlight the clinical profile of HF in regional Uganda and substantial opportunities to improve guideline-directed therapy, self-care, and health system performance.
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Schwartz et al. (2026) conducted an RCT in Heart failure (n=547). Core-HF clinical care improvement bundle plus Medly Uganda digital health bundle vs. Baseline standard care and Core-HF bundle alone was evaluated on Composite of heart failure hospitalization and all-cause mortality (clinical) and Self-Care in Heart Failure Index (implementation). Baseline enrollment in the MEDLY Uganda trial includes 547 outpatient heart failure patients (mean age 57 years, 64% female, mean NT-proBNP 5,267 pg/mL), with 54% reporting medication nonadherence.
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