NCT05955937

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-06
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-07-21
• Last updated: 2025-08-08

Locations

7 sites across 1 country: Uganda