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

Summary

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.

Conditions

• Heart Failure

Interventions

OTHER

Enhanced HF Clinical Care (Core-HF)

All clinical care providers involved in HF care at participating RRHs will be trained in a HF service bundle including a care protocol (treatment algorithm based on global guidelines), self-care training for patients and providers, and medication stock management to ensure supply of HF medications to patients in need.

OTHER

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

A patient-facing mobile health application designed to improve self-care will be provided to the study participant, which will operate on all mobile devices. This will be introduced after the Core-HF intervention has been delivered.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Jeremy Schwartz, MD · Yale University

• Isaac Ssinabulya, MD · Uganda Initiative for Integrated Management of Non-Communicable Diseases (UINCD)

• Joseph Cafazzo, PhD · University Health Network of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-06

Primary Completion

2027-10-31

Completion

2027-10-31

Countries

• Uganda

Study Locations