Heart FailureMEDLY UgandaNCT05955937
ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
A study testing Enhanced HF Clinical Care (Core-HF) and Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF) in people with Heart Failure, run by Yale University at 7 sites in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Enhanced HF Clinical Care (Core-HF) and Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 7 sitesUganda
- Study dates
- 6 Mar 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Uganda7 sites
Arua Regional Referral Hospital
Arua
Fort Portal Regional Referral Hospital
Fort Portal
Uganda Heart Institute
Kampala
Lira Regional Referral Hospital
Lira
Masaka Regional Referral Hospital
Masaka
Mbale Regional Referral Hospital
Mbale
Mbarara Regional Referral Hospital
Mbarara
About this study
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.
Read the 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
- Being tested
- Enhanced HF Clinical Care (Core-HF), Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Participant fidelity will be assessed by self report administered by the Research Assistant. The MARS-5 is a 5-item questionnaire that asks the frequency of behaviors that indicate non-adherence (forgetting to take medications, for example). The range of score is 5-25. A higher score indicates higher adherence (positive outcome of self-care).
Measured: up to 36 months
Change in NYHF Classification
As assessed by clinical care provider, heart failure as measured by the New York Heart Failure Classification 1. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. 2. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest, and 4.Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. Lower classes indicate a positive outcome.
Measured: up to 36 months
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.
Measured: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
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.
Measured: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
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.
Measured: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
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.
Measured: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Facility fidelity to implementation strategy assessed by vital sign checks and other intervention components
Percentage of patients receiving Core HF components (i.e., vital sign checks; self-care guidance) based on the penultimate implementation strategy
Measured: up to 36 months
Facility fidelity to implementation strategy assessed by the availability of medications
Facility fidelity to implementation strategy will be assessed by the prescribing-to-dispensing ratio of HF medications at facility pharmacy
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start6 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jeremy Schwartz, MD, Principal investigator, Yale UniversityIsaac Ssinabulya, MD, Principal investigator, Uganda Initiative for Integrated Management of Non-Communicable Diseases (UINCD)Joseph Cafazzo, PhD, Principal investigator, University Health Network of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955937
- Sponsor's protocol ID
- 2000035428
- Other IDs
- R01HL166585
- Acronym
- MEDLY Uganda
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
- ClinicalTrials.gov ID
- NCT05955937
- Acronym / sponsor ID
- MEDLY Uganda / 2000035428
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Step 1. Core HF intervention period | Experimental | Other: Enhanced HF Clinical Care (Core-HF)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). |
| Step 2. Core-HF plus Medly Uganda digital health intervention | Experimental | Other: Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Step 1. Core HF intervention period |
| 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. | Other | Step 2. Core-HF plus Medly Uganda digital health intervention |
Primary outcome
Change in Self-Care of Heart Failure Index (SCHFI)
Time frame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
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.
Clinical Effectiveness
Time frame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
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.
8 secondary outcomes
Participant fidelity to self-care assessed by medication adherence using Medication Adherence Report Scale (MARS-5) and 7-day recall
Time frame: up to 36 months
Change in NYHF Classification
Time frame: up to 36 months
Change in 6-minute walk test
Time frame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Change in Pro-NT Brain Natriuretic Peptide (Pro-NT BNP)
Time frame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Change in EuroQol -5D (EQ-5D)
Time frame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Facility fidelity to implementation strategy assessed by vital sign checks and other intervention components
Time frame: up to 36 months
Facility fidelity to implementation strategy assessed by the availability of medications
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Schwartz, MD principal investigator
Yale University
Isaac Ssinabulya, MD principal investigator
Uganda Initiative for Integrated Management of Non-Communicable Diseases (UINCD)
Joseph Cafazzo, PhD principal investigator
University Health Network of Toronto
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced HF Clinical Care (Core-HF) and Digital health intervention (Medly Uganda) plus enhanced HF clinical care (Core-HF) in people with Heart Failure, run by Yale University at 7 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Care of Heart Failure Index (SCHFI) (time frame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.