Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure

Study Overview
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Brief Summary
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This pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management.

Detailed Description
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Heart failure continues to be a major public health problem. High-value, guideline-directed medical therapies (GDMT) for heart failure can reduce mortality and improve quality of life. However, large gaps in treatment with GDMT persist. While prior quality improvement efforts have focused on heart failure hospitalizations, there is a critical need to improve the quality-of-care post-discharge when the initiation and up-titration of GDMT is critical to optimizing outcomes. The main purpose of this pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management.

Official Title
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Design of a Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: A combination of a provider-facing desktop and mobile application with a patient-facing mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Diagnosis of heart failure Most recent left ventricular ejection fraction ≤ 40% in the prior year based on echocardiogram, MRI, CT, or nuclear perfusion Primary cardiologist enrolled in the study Currently admitted with upcoming discharge or discharged from hospital within the prior 2 weeks At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or on ≤ 50% of target dose Exclusion Criteria: Receives dialysis Inotropic therapy during hospitalization History of heart transplant or actively listed on heart transplant waiting list History of left ventricular assist device implantation Cardiac amyloidosis Pregnant or currently trying to be pregnant Life expectancy estimated less than 6 months related to non-cardiac comorbidities as per investigator's judgement Actively enrolled in hospice or comfort care Currently participating in an investigational device or drug study or having participated in such a study within 30 days prior to screening Subject or their caregiver without a smartphone Subject or their caregiver not proficient with written and spoken English Subject unavailable to complete all study procedures (e.g., interviews) to the best of the subject and investigator's knowledge Any other disorder or condition that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Subject has diminished decision-making capacity Planned discharge to skilled nursing facility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Digital technology-based system for heart failure management<br>This is a single-arm study to assess the feasibility and preliminary effectiveness of a digital technology-based system for heart failure management | Other: A combination of a provider-facing desktop and mobile application with a patient-facing mobile application<br>* A combination of a provider-facing desktop and mobile application with a patient-facing mobile application that is integrated with a remote blood pressure cuff, heart rate monitor, and scale.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptability of the intervention | The proportion of patients who assess the DOT-HF intervention as an acceptable method of post-discharge heart failure management. This will be assessed during a semi-structured interview between individual participants and a trained interviewer. | At Study completion (12-week follow-up visit) | 
| Patients' Engagement score | A weighted proportion of requested actions completed by the patient. These actions include daily blood pressure measurements, daily weight assessment, daily health status assessment, biweekly KCCQ-12 assessment, and review of educational videos and health summary data. The minimum score is 0% and maximum score is 100%. | At Study completion (12-week follow-up visit) | 
| Clinicians' Response to Notification | The proportion of DOT-HF clinician notifications that lead to a clinician response over the 12-week follow-up period. Each of the clinician DOT-HF notifications are detailed below. These include notification of eligible therapy adjustment, worsening patient-reported health status, and weight gain. Eligible clinician actions include medication changes or new telephone, video, or in-person clinic encounters in response to the notification. | At Study completion (12-week follow-up visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of days with weight assessed | The proportion of days weight is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%. | At Study Completion (12-week follow-up visit) | 
| Proportion of days with daily health status completed | The proportion of days daily health status is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%. | At Study Completion (12-week follow-up visit) | 
| Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed | The proportion of biweekly periods that the Kansas City Cardiomyopathy Questionnaire-12 health status is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%. | At Study Completion (12-week follow-up visit) | 
| Proportion of days with blood pressure (systolic) assessed | The proportion of days blood pressure (systolic) is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%. | At Study Completion (12-week follow-up visit) | 
| Proportion of days with medication adherence assessed | The proportion of days medication adherence is recorded by the participant using the ENGAGE-HF app. The minimum is 0% and maximum is 100%. | At Study Completion (12-week follow-up visit) | 
| Sustainability of DOT-HF technology for Patients | Sustainability will also be assessed via semi-structured interview questions to assess patient's and clinician's interest in continuing to use the DOT-HF intervention. | At 6 week, At Study Completion (12-week follow-up visit) | 
| Feasibility of DOT-HF technology for Patients | Feasibility will be assessed via semi-structured interview questions to assess barriers to use the DOT-HF intervention. | At Study Completion (12 week follow up visit) | 
| Utility of DOT-HF technology for Clinicians | Clinician perception of the utility of DOT-HF will be assessed based on clinician actions in response to DOT-HF notifications. We will assess each of the types of notifications aggregated in co-primary endpoint #3: Notification of eligible therapy adjustment Worsening patient-reported health status Weight gain For each endpoint, we will separately evaluate the proportion of notifications that were followed by a medication adjustment and the proportion that were followed by a previously unplanned encounter between the clinician/clinic nurse and the patient. | At study completion (12 week follow up visit) | 
| Acceptability of DOT-HF technology for Clinicians | Clinician perception of the acceptability of DOT-HF will be assessed by clinician responses to a survey administered at the end of the study and semi-structured interview. | At study completion (12 week follow up visit) | 
| Generalizability of the DOT-HF Intervention | The generalizability of our study will be evaluated by comparing sociodemographic data between participants and eligible individuals who decline participation. Sociodemographics include age, gender, and race. | At study completion (12 week follow up visit) | 
| Guideline-Directed Medical Therapy Score | A score based on the heart failure medications prescribed. The minimum score is 0% and maximum score is 100%. | Baseline, At study completion (12 week follow-up visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Digital Health, Remote monitoring, Mobile Application