Digital Monitoring for Heart Failure

(ADHERE-HF Trial)

Recruiting at 1 trial location

Overseen By Nicholas Hendren, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Substance abuse, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

We will enroll 150 adult participants with systolic heart failure into the ADHERE-HF trial. The study will randomize participants in a 1:2 fashion to usual care or usual care plus the American Heart Association's Digital Solution for 90 days. This wearable device and careplan package is hypothesized to improve rates of guideline directed heart failure medical care for participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual care, but it's best to confirm with the study team.

What data supports the effectiveness of the treatment Biofourmis Digital Platform for heart failure?

Research suggests that digital health tools can improve the quality of life for heart failure patients by enhancing self-care and patient engagement. Additionally, digital home monitoring with specialist support has been shown to be more effective in managing heart failure than monitoring alone. ^{1 2 3 4 5}

Is the Biofourmis Digital Platform safe for use in humans?

The studies reviewed did not specifically address the safety of the Biofourmis Digital Platform, but they did involve digital health technologies for heart failure patients, which were generally well-accepted and did not report any safety concerns. One study noted that using digital tools helped prevent hospital re-admissions, suggesting they were safe and beneficial for monitoring patients. ^{1 6 7 8 9}

How is the Biofourmis Digital Platform treatment unique for heart failure?

The Biofourmis Digital Platform is unique because it uses digital health technology to continuously monitor patients' vital signs and behaviors in real-time, providing personalized feedback and early detection of heart failure exacerbations. This approach enhances self-management and engagement, potentially improving quality of life and reducing healthcare costs. ^{1 2 3 10 11}

Research Team

Nicholas Hendren, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

Adults over 18 with heart failure and a left ventricular ejection fraction of 40% or less. They must have had an echocardiogram or cardiac MRI within the last year to confirm their condition.

Inclusion Criteria

I am over 18 with heart failure and my heart's pumping ability is reduced.

Exclusion Criteria

Survival anticipated <6 months

I have severe kidney disease or am on dialysis.

Unable or unwilling to consent or use study related materials

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care or usual care plus the AHA Digital Solution for heart failure management

12 weeks

Multiple visits (phone, Mychart, clinic visit)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Biofourmis Digital Platform

Trial Overview The trial is testing the Biofourmis Digital Platform, which includes a wearable device and care plan package. It's designed to see if it can improve adherence to heart failure treatment guidelines compared to usual care alone.

Participant Groups

Group I: Device Experimental Treatment 1 Intervention

Participants will receive usual care or usual care plus the American Heart Association's Digital Solution in patients with HFrEF. The Solution is a combination of the AHA/CHTI HF CarePlans and Education Content, delivered through and combined with the Biofourmis Platform.

Group II: Routine Care Active Control 1 Intervention

Routine care for heart failure management

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

Patient-reported outcomes (PROs) are essential for capturing the real-life impact of heart failure on patients, including their symptoms and quality of life, but are not routinely included in clinical trials.

To improve the relevance of PROs in heart failure research and patient care, there is a need for standardized measures and methods for data collection and analysis, as well as further research to establish clinically important thresholds for these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives. Zannad, F., Alikhaani, J., Alikhaani, S., et al.[2023]

The study involved 92 participants with chronic heart failure, who were randomly assigned to either a mobile health intervention group using the iCardia4HF app and connected devices or a control group with only the devices, to assess the feasibility and preliminary efficacy of the intervention.

The main focus was on improving adherence to heart failure self-care practices, such as medication and weight monitoring, with follow-up assessments at 30 days and 12 weeks, while also tracking hospitalizations and emergency visits for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial. Kitsiou, S., Gerber, BS., Kansal, MM., et al.[2023]

The study involved 38 older adults with heart failure, comparing a sensor-controlled digital game (SCDG) intervention to a sensors-only approach over 12 weeks, showing that the SCDG was feasible and well-accepted for encouraging daily weight monitoring and physical activity.

Participants using the SCDG demonstrated a strong correlation between app engagement and adherence to weight monitoring and physical activity, suggesting that gamification can effectively motivate health behaviors in older adults with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. Radhakrishnan, K., Julien, C., Baranowski, T., et al.[2022]

The Biomon-HF project developed and tested innovative sensors for monitoring vital signs during sleep in 115 heart failure patients, showing promise for personalized telemonitoring and therapy management.

These sensors can help detect heart failure exacerbations and related health issues early, potentially reducing complications and healthcare costs while improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". Vollmer, T., Schauerte, P., Zink, M., et al.[2015]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Electronic physiologic and subjective data acquisition in home-dwelling heart failure patients: An assessment of patient use and perception of usability. [2018]

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

Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Life Multimarker Monitoring in Patients with Heart Failure: Continuous Remote Monitoring of Mobility and Patient-Reported Outcomes as Digital End Points in Future Heart-Failure Trials. [2022]

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

Pragmatic randomized trial assessing the impact of digital health technology on quality of life in patients with heart failure: Design, rationale and implementation. [2023]

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

Home monitoring with technology-supported management in chronic heart failure: a randomised trial. [2023]

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

Unraveling the mechanisms for heart failure patients' beliefs about compliance. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives. [2023]

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

Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Digital pen-based telemonitoring of elderly heart failure patients. [2013]

10. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". [2015]