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

NCT05955937 | Active Not Recruiting

• 2 other identifiers: 2000035428R01HL166585
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 7

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Change in Self-Care of Heart Failure Index (SCHFI)

  The SCHFI v7.23 is a validated 39-item instrument hat assesses maintenance, management, and self-confidence of heart failure self-care. Scores range from 0-100 with higher scores indicating improved self care.

  baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

• Clinical Effectiveness

  A composite of the number of participants with mortality and HF hospitalization will be used to assess clinical effectiveness. This outcome is the most widely used composite clinical endpoint in HF trials globally.

  baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

Secondary Outcomes (8)

• Participant fidelity to self-care assessed by medication adherence using Medication Adherence Report Scale (MARS-5) and 7-day recall

  up to 36 months

• Change in NYHF Classification

  up to 36 months

• Change in 6-minute walk test

  baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

• Change in Pro-NT Brain Natriuretic Peptide (Pro-NT BNP)

  baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)

  baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

Study Arms (2)

Step 1. Core HF intervention period

EXPERIMENTAL

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).

Other: Enhanced HF Clinical Care (Core-HF)

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

EXPERIMENTAL

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.

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

Interventions

Enhanced HF Clinical Care (Core-HF) 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 1. Core HF intervention period

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (7)

Arua Regional Referral Hospital

Arua, Uganda

Location

Fort Portal Regional Referral Hospital

Fort Portal, Uganda

Location

Uganda Heart Institute

Kampala, Uganda

Location

Lira Regional Referral Hospital

Lira, Uganda

Location

Masaka Regional Referral Hospital

Masaka, Uganda

Location

Mbale Regional Referral Hospital

Mbale, Uganda

Location

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jeremy Schwartz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Isaac Ssinabulya, MD

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

  PRINCIPAL INVESTIGATOR

• Joseph Cafazzo, PhD

  University Health Network of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After 1-2 month-long run-in periods to allow for integration and adoption of the interventions all sites will receive the multi-component implementation strategy, beginning with the Core HF and followed by Medly Uganda. Sites will be randomized using a randomization software to receive the interventions at different start points after the first six months, for varying durations throughout the 3-year study period.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: March 6, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (7)