Digital-first care model for heart failure in Uganda
ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
This study is testing a new digital health program to help people in Uganda with heart failure take better care of themselves and see if it reduces hospital visits and improves their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 576 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 7 sites (Arua and 6 other locations) |
| Trial ID | NCT05955937 on ClinicalTrials.gov |
What this trial studies
This study implements a digital-first, multi-component strategy to enhance heart failure self-care in Uganda through a stepped wedge, cluster-randomized design. It evaluates the effectiveness of an enhanced standard-of-care clinical bundle and a digital health intervention called Medly Uganda across six regional referral hospitals. The study aims to assess both implementation and clinical outcomes, including self-care and rates of mortality and hospitalization due to heart failure. Additionally, a mixed methods process evaluation will inform adjustments to the implementation process and explore cost-effectiveness and sustainability factors.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with NYHA Class II-III heart failure who have access to a mobile phone and basic reading skills in one of the local languages.
Not a fit: Patients with active medical conditions requiring hospitalization or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart failure management and patient outcomes in Uganda.
How similar studies have performed: Other studies have shown promise with digital health interventions for chronic conditions, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Arua and 6 other locations
- Arua Regional Referral Hospital — Arua, Uganda (Recruiting)
- Fort Portal Regional Referral Hospital — Fort Portal, Uganda (Recruiting)
- Uganda Heart Institute — Kampala, Uganda (Not_yet_recruiting)
- Lira Regional Referral Hospital — Lira, Uganda (Not_yet_recruiting)
- Masaka Regional Referral Hospital — Masaka, Uganda (Recruiting)
- Mbale Regional Referral Hospital — Mbale, Uganda (Recruiting)
- Mbarara Regional Referral Hospital — Mbarara, Uganda (Recruiting)
Study contacts
- Principal investigator: Jeremy Schwartz, MD — Yale University
- Study coordinator: Jeremy Schwartz, MD
- Email: jeremy.schwartz@yale.edu
- Phone: 203-680-1598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.