ENGAGE-HF Mobile App for Heart Failure

(ENGAGE-HF Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Michael Dorsch, PharmD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Must be taking: Heart failure therapies

Disqualifiers: Dialysis, Transplant history, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on optimizing heart failure medications, so you may need to adjust your current heart failure treatments.

What data supports the effectiveness of the ENGAGE-HF Mobile Application treatment for heart failure?

Research shows that mobile health apps can improve the quality of life for heart failure patients by helping them manage their condition better, even though not all studies showed positive results for other outcomes. These apps assist patients in tracking important health indicators like blood pressure and weight, which can lead to better self-care.

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Is the ENGAGE-HF Mobile App safe for use in humans?

The ENGAGE-HF Mobile App has been studied for its safety, effectiveness, and usability in patients with heart failure. In a study involving 55 patients, the app was used as part of a follow-up program after heart failure hospitalization, and no specific safety concerns were reported.

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How is the ENGAGE-HF Mobile App treatment different from other heart failure treatments?

The ENGAGE-HF Mobile App is unique because it uses mobile health technology to help patients with heart failure manage their symptoms and medication adherence through self-monitoring and education, which is different from traditional treatments that primarily focus on medication and lifestyle changes without the use of technology.

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Eligibility Criteria

This trial is for heart failure patients recently hospitalized or discharged, with a left ventricular ejection fraction below 50%. Participants should not have started at least two recommended heart failure treatments, or be on less than half the target dose.

Inclusion Criteria

I have been diagnosed with heart failure.

My heart's pumping ability is below 50% or I have documented heart failure.

I am not on full doses of at least two recommended heart failure medications.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the ENGAGE-HF mobile application integrated with a remote blood pressure cuff and scale, along with a clinician-facing dashboard, to optimize heart failure management.

12 weeks

Regular virtual monitoring

Cognitive Function Sub-study (optional)

Eligible participants are invited to participate in a sub-study assessing cognitive function using various neurocognitive assessments.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessments of medication optimization and quality of life.

4 weeks

Participant Groups

The ENGAGE-HF mobile app is being tested to see if it can help manage heart failure by tracking health status, vital signs and weight, and medication quality. It includes self-monitoring features and provides feedback through a clinician dashboard.

Group I: Intervention Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

Participants randomized to the control group will receive usual heart failure care.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford Cardiovascular Clinic Stanford, CA

The Johns Hopkins Hospital Baltimore, MD

U-M Frankel Cardiovascular Center Ann Arbor, MI

Who Is Running the Clinical Trial?

University of Michigan Lead Sponsor

Johns Hopkins University Collaborator

Boston University Collaborator

Stanford University Collaborator

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The role of patient-oriented mHealth interventions in improving heart failure outcomes: A systematic review of the literature. [2023] Heart failure (HF) is a debilitating disease with 26 million patients worldwide. Consistent and complex self-care is required on the part of patients to adequately adhere to medication and to the lifestyle changes that the disease necessitates. Mobile health (mHealth) is being increasingly incorporated in patient interventions in HF, as smartphones prove to be ideal platforms for patient education and self-help assistance. This systematic review aims to summarize and report on all studies that have tested the effect of mHealth on HF patient outcomes. Our search yielded 17 studies, namely 11 randomized controlled trials and six non-randomized prospective studies. In these, patients with the assistance of an mHealth intervention regularly measured their blood pressure and/or body weight and assessed their symptoms. The outcomes were mostly related to hospitalizations, clinical biomarkers, patients' knowledge about HF, quality of life (QoL) and quality of self-care. QoL consistently increased in patients who received mHealth interventions, while study results on all other outcomes were not as ubiquitously positive. The first mHealth interventions in HF were not universally successful in improving patient outcomes but provided valuable insights for patient-oriented application development. Future trials are expected to build on these insights and deploy applications that measurably assist HF patients.

2. England pubmed.ncbi.nlm.nih.gov

The AppCare-HF randomized clinical trial: a feasibility study of a novel self-care support mobile app for individuals with chronic heart failure. [2023] We evaluated a self-care intervention with a novel mobile application (app) in chronic heart failure (HF) patients. To facilitate patient-centred care in HF management, we developed a self-care support mobile app to boost HF patients' optimal self-care.

3. Ireland pubmed.ncbi.nlm.nih.gov

Effect and usability of mobile health applications for medication adherence in patients with heart failure: A systematic review. [2023] This review aimed to evaluate the effect of mobile health applications (apps) use on medication adherence in heart failure (HF) patients, and to verify their quality of use.

4. Canada pubmed.ncbi.nlm.nih.gov

Smartphone Ownership and Interest in Mobile Health Technologies for Self-care Among Patients With Chronic Heart Failure: Cross-sectional Survey Study. [2022] Heart failure (HF) is a highly prevalent chronic condition that places a substantial burden on patients, families, and health care systems worldwide. Recent advances in mobile health (mHealth) technologies offer great opportunities for supporting many aspects of HF self-care. There is a need to better understand patients' adoption of and interest in using mHealth for self-monitoring and management of HF symptoms.

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness and usability of a novel mobile phone-based self-care intervention for patients with heart failure: a mixed-methods pilot study. [2023] To evaluate the preliminary effectiveness and usability of a novel mobile phone-based self-care intervention (named WithUs) for patients with heart failure (HF).

6. United States pubmed.ncbi.nlm.nih.gov

The Development and Acceptability of a Mobile Application for Tracking Symptoms of Heart Failure Among Older Adults. [2019] Heart failure (HF) is common in older adults. With increases in technology use among older adults, mobile applications may provide a solution for older adults to self-manage symptoms of HF. This article discusses the development and acceptability of a HF symptom-tracking mobile application (HF app).

7. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of a Telemedicine Program After a Heart Failure Hospitalization on 12 Months Follow-Up Events. [2023] The aim of this study was to describe the safety, effectiveness, and usability of a mobile-app based follow up platform after a heart failure (HF) hospitalization. It was a pilot, prospective implementation study. 55 consecutive patients were included. Over 12 months, a significant increase in the use of renin angiotensin system inhibitors was observed (91% vs 76%, P

8. Netherlands pubmed.ncbi.nlm.nih.gov

Perceptions of Older Adults with Heart Failure on Playing an Interactive Digital e-Health Game (IDEG) for Learning About Heart Failure (HF): Prototype Development and Usability Testing. [2018] Effective self-management can decrease up to 50% of heart failure (HF) hospitalizations. However, self-management by patients with HF remains poor. We describe the development and usability testing of an interactive digital e-health game (IDEG) for older patients with HF in Central Texas, USA. Majority of the participants (5 out of 6) who participated in the usability testing found the game interesting, enjoyable and helpful to play. Developing an IDEG that is satisfying and acceptable to older adults with HF is feasible.

9. Canada pubmed.ncbi.nlm.nih.gov

Passively Captured Interpersonal Social Interactions and Motion From Smartphones for Predicting Decompensation in Heart Failure: Observational Cohort Study. [2022] Heart failure (HF) is a major cause of frequent hospitalization and death. Early detection of HF symptoms using smartphone-based monitoring may reduce adverse events in a low-cost, scalable way.

10. Ireland pubmed.ncbi.nlm.nih.gov

Self-management in heart failure using mHealth: A content validation. [2023] To describe the development of a mobile health application -mICardiApp- designed by a multidisciplinary professional team and patients with heart failure and to evaluate its content validity.

11. Canada pubmed.ncbi.nlm.nih.gov

Evaluating Health Care Provider Perspectives on the Use of Mobile Apps to Support Patients With Heart Failure Management: Qualitative Descriptive Study. [2022] Nonadherence to diet and medical therapies in heart failure (HF) contributes to poor HF outcomes. Mobile apps may be a promising way to improve adherence because they increase knowledge and behavior change via education and monitoring. Well-designed apps with input from health care providers (HCPs) can lead to successful adoption of such apps in practice. However, little is known about HCPs' perspectives on the use of mobile apps to support HF management.