ENGAGE-HF Mobile App for Heart Failure

(ENGAGE-HF Trial)

Recruiting at 2 trial locations

Overseen By Brad Trumpower, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Heart failure therapies

Disqualifiers: Dialysis, Transplant history, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{3 4 6 10 11}

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.

Research Team

Michael Dorsch, PharmD

Principal Investigator

University of Michigan

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.

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

Treatment Details

Interventions

• ENGAGE-HF Mobile Application

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Findings from Research

Mobile health (mHealth) interventions have been shown to significantly improve the quality of life for heart failure patients, based on a systematic review of 17 studies including 11 randomized controlled trials.

While mHealth interventions did not consistently improve all patient outcomes, they provided important insights for developing future applications aimed at better supporting heart failure patients in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of patient-oriented mHealth interventions in improving heart failure outcomes: A systematic review of the literature. Mouselimis, D., Tsarouchas, A., Vassilikos, VP., et al.[2023]

A novel mobile app designed for self-care in chronic heart failure patients showed excellent adherence to self-monitoring vital signs, with the intervention group achieving 100% adherence for most measures over a 2-month period.

Patients using the app demonstrated significantly improved self-care behavior scores compared to those using a traditional HF diary, indicating that the app is a feasible tool for enhancing self-management in heart failure.

NCBI (Pubmed)

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. Yokota, T., Fukushima, A., Tsuchihashi-Makaya, M., et al.[2023]

Mobile health applications have shown potential to improve medication adherence in heart failure patients, with significant results reported in two randomized clinical trials and two observational studies involving a total of 484 participants.

Despite the positive findings, the overall quality of evidence is very low, and the reliance on self-reported measures for adherence may introduce biases, indicating a need for further research to confirm these effects and determine optimal usage strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and usability of mobile health applications for medication adherence in patients with heart failure: A systematic review. Alves Leite de Barros, KA., da Silva Praxedes, MF., Pinho Ribeiro, AL., et al.[2023]

A study of 100 heart failure patients revealed that 68% owned smartphones, with higher ownership rates among Black or African American and Hispanic or Latino patients compared to White patients, indicating a potential for mHealth technology adoption in these communities.

Participants expressed strong interest in using mHealth apps for self-monitoring key health metrics like physical activity, blood pressure, and medication adherence, suggesting that integrating these technologies could enhance heart failure self-management.

NCBI (Pubmed)

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. Leigh, JW., Gerber, BS., Gans, CP., et al.[2022]

The WithUs mobile app significantly improved eHealth literacy, disease knowledge, and self-care behaviors in 26 heart failure patients over a 24-week period, indicating its effectiveness as a self-care intervention.

Participants rated the app's usability highly (median score of 4.1 out of 5), but suggested modifications to enhance its adoption, highlighting the need for ongoing improvements to support heart failure patients effectively.

NCBI (Pubmed)

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. Son, YJ., Kim, EY.[2023]

A mobile application designed for older adults to track heart failure symptoms was found to be easy to use and well-accepted by participants, indicating its potential for self-management of heart failure.

Feedback from 30 older adults suggested that the app could be improved by adding more symptoms to track and including instructions and reminders, which could enhance its effectiveness in preventing heart failure readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development and Acceptability of a Mobile Application for Tracking Symptoms of Heart Failure Among Older Adults. Portz, JD., Vehovec, A., Dolansky, MA., et al.[2019]

In a pilot study involving 55 patients recently discharged from heart failure hospitalization, a mobile app-based follow-up platform significantly increased the use of renin-angiotensin system inhibitors from 76% to 91% over 12 months, indicating improved medication adherence.

The study demonstrated high usability of the app, with a remarkable 96% adherence rate to medication reported by patients, and only one hospitalization for heart failure during the follow-up period, suggesting that this telemedicine approach is safe and effective for managing heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Telemedicine Program After a Heart Failure Hospitalization on 12 Months Follow-Up Events. Sosa Liprandi, MI., Elfman, M., Zaidel, EJ., et al.[2023]

An interactive digital e-health game (IDEG) was developed to improve self-management in older patients with heart failure, which is crucial since effective self-management can reduce hospitalizations by up to 50%.

Usability testing showed that 5 out of 6 participants found the game interesting, enjoyable, and helpful, indicating that such digital tools can be both feasible and acceptable for older adults with heart failure.

NCBI (Pubmed)

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. Radhakrishnan, K., Toprac, P., O'Hair, M., et al.[2018]

A study involving 28 heart failure patients demonstrated that smartphone-based monitoring, which combined passive data (like movement and social interactions) and active surveys, can effectively predict heart failure decompensation events, achieving a high accuracy with an AUC of 0.83 for a 2-day prediction window.

The findings suggest that social data, such as the frequency and duration of phone calls, can provide valuable insights into a patient's health status, indicating that smartphone monitoring could be a cost-effective alternative to traditional monitoring methods for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passively Captured Interpersonal Social Interactions and Motion From Smartphones for Predicting Decompensation in Heart Failure: Observational Cohort Study. Cakmak, AS., Perez Alday, EA., Densen, S., et al.[2022]

The mICardiApp, developed with input from both healthcare professionals and patients with heart failure, aims to enhance health literacy and self-management for individuals with heart failure and multimorbidity.

The app's content was rigorously validated, achieving a high Content Validity Index (CVI) of 0.851, indicating that most of its screens (57 out of 59) were deemed relevant and adequate by experts, ensuring its effectiveness as a health management tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management in heart failure using mHealth: A content validation. Fernández-Gutiérrez, M., Bas-Sarmiento, P., Jesús Marín-Paz, A., et al.[2023]

Healthcare providers (HCPs) believe that mobile apps can significantly enhance heart failure (HF) management by improving patient engagement, facilitating remote care, and providing educational support, based on interviews with 21 HCPs including cardiologists and nurses.

Challenges to app adoption include patient factors like age and technology access, but HCPs see potential in features like reminders and gamification to encourage adherence to treatment and self-care.

NCBI (Pubmed)

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. Sivakumar, B., Lemonde, M., Stein, M., et al.[2022]

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]

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]

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]

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]

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]

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]

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

Impact of a Telemedicine Program After a Heart Failure Hospitalization on 12 Months Follow-Up Events. [2023]

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]

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]

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

Self-management in heart failure using mHealth: A content validation. [2023]

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]