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ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda)

Award Number: R01HL166585
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2023
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda) - 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 differences 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, multi-component strategy for HF (Medly Uganda) to improve selfcare 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 geographic and socioeconomic diversity. 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 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 predetermined 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 impact 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 and cost-effectiveness 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	3	11/28/2025	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $798,023 )
2025	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	3	9/13/2025	NON-COMPETING CONTINUATION	$207,722
2025	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	3	9/22/2025	SUPPLEMENT FOR EXPANSION	$235,673
2025	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	004	3	9/22/2025	SUPPLEMENT FOR EXPANSION	$35,478
2025	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	003	3	9/22/2025	SUPPLEMENT FOR EXPANSION	$319,150
2025	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	2	10/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $798,023

Issue Date FY: 2024 ( Subtotal = $847,310 )
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	2	8/30/2024	SUPPLEMENT FOR EXPANSION	$69,434
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	003	2	9/17/2024	SUPPLEMENT FOR EXPANSION	$235,580
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	2	8/9/2024	NON-COMPETING CONTINUATION	$542,296
2024	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	1	8/7/2024	NEW	$0
														Subtotal = $847,310

Issue Date FY: 2023 ( Subtotal = $591,259 )
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	1	8/1/2023	NEW	$591,259
														Subtotal = $591,259

Grand Total All Awards = $2,236,592

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ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda)

Award Number: R01HL166585

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2023

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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