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

Heart Failure Clinical Trial

— MEDLY Uganda  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05955937
• Other study ID #: 2000035428
• Secondary ID: 1R01HL166585-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2027

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Jeremy Schwartz, MD
• Phone: 203-680-1598
• Email: jeremy.schwartz[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 575
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: Lusoga in Jinja, Runyankole in Mbarara, Luganda in Masaka, Rutooro in Fort Portal, Acholi in Gulu, and Alur 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 will be consented and enrolled to compensate for these exclusions.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Uganda	Fort Portal Regional Referral Hospital	Fort Portal
Uganda	Gulu Regional Referral Hospital	Gulu
Uganda	Jinja Regional Referral Hospital	Jinja
Uganda	Lira Regional Referral Hospital	Lira
Uganda	Masaka Regional Referral Hospital	Masaka
Uganda	Mbarara Regional Referral Hospital	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Primary	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, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Participant fidelity to self-care assessed by medication adherence	Participant fidelity will be assessed by self report administered by the Research Assistant.	up to 36 months
Secondary	Participant fidelity to self-care assessed by optimal HF medication dosing	Participant fidelity to self-care assessed by the percentage of participants that achieve optimal HF medication dosing assessed by self report	up to 36 months
Secondary	Participant fidelity to self-care assessed by self report	Participant fidelity to self-care assessed by self reported adherence to dietary sodium restriction and exercise recommendations	up to 36 months
Secondary	Facility fidelity to implementation strategy assessed by vital sign checks	Facility fidelity to implementation strategy will be assessed by the percentage of participants receiving vital sign checks	up to 36 months
Secondary	Change in blood pressure	Facility fidelity to implementation strategy will be assessed by change in blood pressure. Lower blood pressure indicates a positive outcome.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Change in weight	Facility fidelity to implementation strategy will be assessed by change in weight measured in pounds. Lower weight indicates a positive outcome.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Change in resting pulse	Facility fidelity to implementation strategy will be assessed by change in resting pulse measured in beats per minute. Slower pulse indicates a positive outcome.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Percentage of planned echo training sessions conducted with post-training participant feedback	Facility fidelity to implementation strategy will be assessed by the percentage of planned echo training sessions conducted with post-training participant feedback	up to 36 months
Secondary	Facility fidelity to implementation strategy assessed by the adherence to medications	Facility fidelity to implementation strategy will be assessed by the prescribing-to-dispensing ratio of HF medications at facility pharmacy by self report	up to 36 months
Secondary	Change in 6-minute walk test	The 6-minute walk test monitors physical conditioning. It measures the distance an individual can walk over a total of six minutes on a hard, flat surface. The individual can self-pace and rest as needed as they walk back and forth along a marked course. The participant can use an assistive walking device they normally use, such as a cane. The minimum clinically important difference in 6-minute walk distance is approximately 30 meters, a difference that is associated with mortality.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Change in Pro-NT Brain Natriuretic Peptide (Pro-NT BNP)	Levels of Pro-NT BNP, a widely used prognostic marker in HF, will be measured in blood samples in pg/mL. Lower values indicate a positive outcome.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Change in Left Ventricular Ejection Fraction	Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is <50%. High is >=50%. LVEF is measured by echocardiogram using Simpson biplane formula	6 months, 18 months and 36 months
Secondary	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)	The KCCQ is a 12-item questionnaire that measures symptoms, physical and social limitations, and quality of life in participants with heart failure. KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Change in EuroQol -5D (EQ-5D)	EQ-5D 5L is a standardized participant completed questionnaire that measures health-related quality of life. It is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Secondary	Change in Patient Health Questionnaire-9 (PHQ-9)	Health-related quality of life will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of =10 is considered positive with lower scores indicating no or mild anxiety.	baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months