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

Last updated: April 1, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Congestive Heart Failure

Chest Pain

Treatment

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

Enhanced HF Clinical Care (Core-HF)

Clinical Study ID

NCT05955937
2000035428
R01HL166585
1R01HL166585-01A1
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 clinicalcare provider. Languages will include: Lugbara in Arua, Lugiso in Mbale, Runyankolein Mbarara, Luganda in Masaka, Rutooro in Fort Portal, and Langi in Lira in additionto English.

Exclusion

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 (acuteelectrocardiographic changes and/or positive biomarkers, if available), syncope, orsignificant fluid overload

  • Echocardiography findings that do not support a diagnosis of HF as determined duringa study visit. This exclusion might occur following enrollment and new patients maybe consented and enrolled to compensate for these exclusions.

Study Design

Total Participants: 576
Treatment Group(s): 2
Primary Treatment: Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF)
Phase:
Study Start date:
March 06, 2025
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • Arua Regional Referral Hospital

    Arua,
    Uganda

    Site Not Available

  • Fort Portal Regional Referral Hospital

    Fort Portal,
    Uganda

    Site Not Available

  • Gulu Regional Referral Hospital

    Gulu,
    Uganda

    Site Not Available

  • Jinja Regional Referral Hospital

    Jinja,
    Uganda

    Site Not Available

  • Uganda Heart Institute

    Kampala,
    Uganda

    Site Not Available

  • Lira Regional Referral Hospital

    Lira,
    Uganda

    Site Not Available

  • Masaka Regional Referral Hospital

    Masaka,
    Uganda

    Active - Recruiting

  • Mbale Regional Referral Hospital

    Mbale,
    Uganda

    Site Not Available

  • Mbarara Regional Referral Hospital

    Mbarara,
    Uganda

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.