ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda (NCT05955937) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
Uganda576 participantsStarted 2025-03-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a 'digital-first' care model for heart failure in Uganda — what does that actually mean in practice for how I would receive my care and communicate with my medical team?
2Since this study is measuring how well patients manage their own heart failure using something called the Self-Care of Heart Failure Index, can you explain what self-care skills I'd be expected to learn and track, and whether that's realistic given my current situation?
3The trial is listed as 'active but not recruiting' — does that mean there's any chance of joining, or would you recommend I look at other options given that enrollment is already closed?
4Because this trial is listed as Phase NA, meaning it's more of a care delivery study than a drug or device trial, how confident can we be about the clinical effectiveness of this digital approach compared to my current standard of care?
5Given that this study is based in Uganda, is this care model something that would even be applicable or accessible to me, and are there similar digital heart failure management programs closer to home that might be worth exploring with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Self-Care of Heart Failure Index (SCHFI)