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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Johns Hopkins University | OTHER |
| Boston University | OTHER |
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The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure.
In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life.
An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The ENGAGE-HF intervention is a combination of a patient-facing mobile application that is integrated with a remote blood pressure cuff and scale along with a clinician-facing dashboard. The mobile application helps complete standard ambulatory monitoring recommended by heart failure clinicians. Simultaneously, the application includes visualizations of that data and education for patients that is intended to promote patient engagement and patient understanding of heart failure care. The information is then made available to treating clinicians via a PDF summary to facilitate outpatient management of the patient by the clinician. There are also a select set of notifications triggered by the ENGAGE-HF platform that will be transmitted to the treating clinician. |
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| Control Group | No Intervention | Participants randomized to the control group will receive usual heart failure care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENGAGE-HF Mobile Application | Device | The mobile app aids ambulatory heart failure monitoring and patient engagement through several features: Physiologic Monitoring: Daily tracking of blood pressure, weight, and heart rate using Bluetooth devices. Data is shown in graphical and tabular formats. Health Status Assessment: Biweekly KCCQ-12 surveys and dizziness questions provide scores (0-100), helping visualize therapy benefits and medication adherence, and reducing clinician inertia. Medication Checklist: Lists current medications and target doses for common heart failure therapies, encouraging adherence and optimization, with alerts for potential improvements. Education: Animated videos from heart failure experts and societies explain medications, monitoring rationale, app features, and interpretation of data. The app enhances heart failure management via consistent monitoring, assessment, medication adherence, and educational content. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication optimization score at 90 days | The primary outcome will be the difference in the medication optimization score at 90 days between the intervention and control group. The MOS is a percent between 0 (least optimized) and 100 (most optimized), which represents the extent of medication optimization that needs to be performed. Inputs for the score include medications, vital signs, and laboratory values, and thus, the score accounts for contraindications to medical therapy titration. The score has been shown to correlate with clinical outcomes in two large randomized controlled trials. | From enrollment to the end of participation at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ-23) | The secondary outcome will be heart failure symptoms as assessed by the difference between the intervention and the control groups in the 23-item Kansas City Cardiomyopathy Questionnaires (KCCQ-23) clinical summary score at 90 days. The KCCQ-23 quantifies patients' health status over the prior 2 weeks and has extensive data supporting its validity, reliability, and sensitivity to clinical change. Scores will be transformed into a 0-100 point rating, with lower scores representing worse health status. |
| Measure | Description | Time Frame |
|---|---|---|
| Kansas City Medical Optimization (KCMO) score | Kansas City Medical Optimization (KCMO) is the average total daily dose for each eligible Guideline-Directed Medical Therapy (GDMT) drug class divided by its target dose. The investigators will compare this score with the primary outcome measure. | From enrollment to the end of participation at 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Dorsch, PharmD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cardiovascular Clinic | Stanford | California | 94305 | United States | ||
| The Johns Hopkins Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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1:1 randomization by site
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| Baseline and at 90 days |
| Modified Continuous 4-Pillar Score |
The Modified Continuous 4-Pillar Score (C4P) score is a continuous version of the 4P Intensification Score, where each dose escalation leads to an increase in the score rather than assigning the same points to a range of increasing GDMT doses. For Beta Blockers, ACEI/ARBs, MRAs, and SGLT2 inhibitor, the C4P score is calculated as 2 + 2 × (% of target daily dose) for patients on therapy to a max score of 4. For ARNI therapy, the score is calculated as 4 + 2 × (% of target daily dose). The score range is from 0 to 18. A higher score is a better outcome. |
| From enrollment to the end of participation at 90 days |
| 90 day all-cause mortality | Participant deaths | From enrollment to the end of participation at 90 days |
| Heart failure hospitalization | Participant hospitalization due to heart failure. Heart failure hospitalizations will be defined as outlined by the Heart Failure Collaboratory and Academic Research Consortium | From enrollment to the end of participation at 90 days |
| Emergency department visits for heart failure | Participant visits to the emergency department for heart failure. Emergency department visits will use a modified version of the criteria of the Heart Failure Collaboratory and Academic Research Consortium without the 24 hour hospital admission requirement. | From enrollment to the end of participation at 90 days |
| Outpatient intravenous diuresis | Participant undergoes outpatient intravenous diuresis. | From enrollment to the end of participation at 90 days |
| Process measures | The investigators will evaluate process measures related to use of the intervention and downstream clinical processes. This will include patient engagement with the ENGAGE-HF mobile application and the subcomponents of engagement with respect to the different aspects of the mobile application. | From enrollment to the end of participation at 90 days |
| Mini-Cog Cognitive Assessment | The Mini-Cog is a brief screening tool used to assess cognitive function, particularly memory and executive function, in study participants. The assessment consists of two components: a three-item recall test and a clock-drawing test (CDT). The three-item recall test evaluates short-term memory by requiring participants to remember and later recall three unrelated words. The CDT assesses executive function and visual-spatial skills by requiring participants to draw a clock with a specified time. | At baseline |
| Memory Recall - Immediate | In the Memory Recall - Immediate part of the INTACT neurocognitive assessment, participants recall and select five animal names. Measured by the average number of correct responses (0-5) and completion time (seconds). | Baseline and at 90 days |
| Choice Reaction Time | In the Choice Reaction Time part of the INTACT neurocognitive assessment, participants identify the direction of an arrow in an odd-colored block among three. Measured by the proportion of correct responses (true/false) and average reaction time (seconds). | Baseline and at 90 days |
| Visual Paired Associates | In the Visual Paired Associates part of the INTACT neurocognitive assessment, participants match image pairs after learning them. Measured by the proportion of correct responses (true/false) and average reaction time (seconds). | Baseline and at 90 days |
| Digit Symbol Matching | In the Digit Symbol Matching part of the INTACT neurocognitive assessment, participants match symbols to numbers using a reference. Measured by the proportion of correct responses (true/false) and average reaction time (seconds). | Baseline and at 90 days |
| Spatial Memory | In the Spatial Memory part of the INTACT neurocognitive assessment, participants recreate increasingly complex block designs. Measured by the proportion of correct responses (true/false) and average reaction time (seconds). | Baseline and at 90 days |
| Memory Recall - Delayed | In the Memory Recall - Delayed part of the INTACT neurocognitive assessment, participants recall the five animal names from the immediate recall test after a delay. Measured by the average number of correct responses (0-5) and completion time (seconds). | Baseline and at 90 days |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| U-M Frankel Cardiovascular Center | Ann Arbor | Michigan | 48109 | United States |