RecruitingNot ApplicableNCT05955937

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


Sponsor

Yale University

Enrollment

576 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study in Uganda is testing a digital-first heart failure care model — using a mobile phone app to help patients manage their heart failure from home. The goal is to make heart failure care more accessible in resource-limited settings. **You may be eligible if...** - You have been diagnosed with moderate heart failure (NYHA Class II or III) - You own or have access to a mobile phone - You can read in one of the supported local languages or English **You may NOT be eligible if...** - You are currently too sick to safely participate (e.g., active chest pain, fainting, or severe fluid overload requiring hospitalization) - You are unable to give informed consent - Your heart scans do not confirm a heart failure diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREnhanced 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.

OTHERDigital 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.


Locations(7)

Arua Regional Referral Hospital

Arua, Uganda

Fort Portal Regional Referral Hospital

Fort Portal, Uganda

Uganda Heart Institute

Kampala, Uganda

Lira Regional Referral Hospital

Lira, Uganda

Masaka Regional Referral Hospital

Masaka, Uganda

Mbale Regional Referral Hospital

Mbale, Uganda

Mbarara Regional Referral Hospital

Mbarara, Uganda

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NCT05955937


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