Clinical trial NCT05955937: ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
Official title: ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-07-21
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Change in Self-Care of Heart Failure Index (SCHFI)
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical Effectiveness
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary outcomes:
measure: Participant fidelity to self-care assessed by medication adherence using Medication Adherence Report Scale (MARS-5) and 7-day recall
timeFrame: up to 36 months
measure: Change in NYHF Classification
timeFrame: up to 36 months
measure: Change in 6-minute walk test
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Change in Pro-NT Brain Natriuretic Peptide (Pro-NT BNP)
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Change in EuroQol -5D (EQ-5D)
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Facility fidelity to implementation strategy assessed by vital sign checks and other intervention components
timeFrame: up to 36 months
measure: Facility fidelity to implementation strategy assessed by the availability of medications
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Arua
country: Uganda
facility: Arua Regional Referral Hospital
city: Fort Portal
country: Uganda
facility: Fort Portal Regional Referral Hospital
city: Kampala
country: Uganda
facility: Uganda Heart Institute
city: Lira
country: Uganda
facility: Lira Regional Referral Hospital
city: Masaka
country: Uganda
facility: Masaka Regional Referral Hospital
city: Mbale
country: Uganda
facility: Mbale Regional Referral Hospital
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
affiliation: Yale University
name: Jeremy Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda Initiative for Integrated Management of Non-Communicable Diseases (UINCD)
name: Isaac Ssinabulya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network of Toronto
name: Joseph Cafazzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: