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

NCT ID: NCT05955937

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-06
• Study Completion Date: 2027-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Step 1. Core HF intervention period

All sites will be trained in an evidence-based clinical care bundle for HF, to ensure standardized basic HF care across the participating RRHs in the study. For this service bundle which will augment self-care (Core-HF), the investigators will train providers in an evidence-based HF clinical care service bundle including a care protocol (treatment algorithm for HF), self-care training for patients and providers, and medication stock management prior to introducing the digital health intervention (Medly Uganda, described in Arm 2).

Group Type: EXPERIMENTAL

Enhanced HF Clinical Care (Core-HF)

Intervention Type: OTHER

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.

Step 2. Core-HF plus Medly Uganda digital health intervention

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 will support an integrated, digital interface at participating hospitals to monitor and intervene with patients who are using the mobile health application.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Isaac Ssinabulya, MD

Role: PRINCIPAL_INVESTIGATOR

Uganda Initiative for Integrated Management of Non-Communicable Diseases (UINCD)

Joseph Cafazzo, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network of Toronto

Locations

Arua Regional Referral Hospital

Arua, , Uganda

Site Status: RECRUITING

Fort Portal Regional Referral Hospital

Fort Portal, , Uganda

Site Status: RECRUITING

Uganda Heart Institute

Kampala, , Uganda

Site Status: NOT_YET_RECRUITING

Lira Regional Referral Hospital

Lira, , Uganda

Site Status: NOT_YET_RECRUITING

Masaka Regional Referral Hospital

Masaka, , Uganda

Site Status: RECRUITING

Mbale Regional Referral Hospital

Mbale, , Uganda

Site Status: RECRUITING

Mbarara Regional Referral Hospital

Mbarara, , Uganda

Site Status: RECRUITING

Countries

Uganda

Central Contacts

Jeremy Schwartz, MD

Role: CONTACT

jeremy.schwartz@yale.edu

203-680-1598

Sarah Christie, MPH, PhD

Role: CONTACT

sarah.christie@yale.edu

475-439-4660

Facility Contacts

Isaac Ssinabulya

Role: primary

ssinabulyaisaac@gmail.com

256 782 083968

Isaac Ssinabulya, MBChB

Role: primary

ssinabulyaisaac@gmail.com

256 782 083968

Isaac Ssinabulya, MBChB

Role: primary

ssinabulyaisaac@gmail.com

+256 782 083968

Isaac Ssinabulya, MBChB

Role: primary

ssinabulyaisaac@gmail.com

256 782 083968

Isaac Ssinabulya, MBChB

Role: primary

ssinabulyaisaac@gmail.com

256 782 083968

Other Identifiers

R01HL166585

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000035428

Identifier Type: -

Identifier Source: org_study_id