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

Yale University

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Enhanced HF Clinical Care (Core-HF); Other: Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05955937

2000035428

R01HL166585 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 576 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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576 participants in 2 patient groups

Step 1. Core HF intervention period

Experimental group

Description:

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).

Treatment:

Other: Enhanced HF Clinical Care (Core-HF)

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

Experimental group

Description:

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.

Treatment:

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