Digital Aid for Heart Failure

Recruiting at 1 trial location

Overseen By Randall S Stafford, MD, PhD, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Past ICD, Mechanical valve, Recent MI, others

Compensation: Varies

Number of Visits: 1

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on developing a digital tool to assist patients with advanced heart failure in making informed decisions about receiving an Implantable Cardioverter-Defibrillator (ICD), a device that can prevent sudden cardiac death. The trial will evaluate a decision-making app that provides personalized risk information to patients and their doctors. Participants will either use the app with personal risk details, use it without these details, or receive standard care without the app. This trial suits patients diagnosed with severe heart failure who have not yet received an ICD. As an unphased trial, it allows patients to contribute to innovative research that may enhance decision-making tools for heart failure care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on developing a digital tool for decision-making about heart devices, not on medication changes.

What prior data suggests that this digital decision-making app is safe for heart failure patients?

Research has shown that digital tools for heart failure, like the app under study, have been successfully used in other areas. People generally find these tools easy to use, and they help users make better health decisions by providing clear and useful information.

Specific data on side effects or safety issues with these apps for decision-making is lacking, likely because they don't involve taking medicine or undergoing physical treatments. Instead, they offer information to guide health choices.

Joining a trial using this kind of app is expected to be safe based on knowledge of similar digital tools. Participants should feel free to ask the study team any questions about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Aid for Heart Failure trial because it explores how technology can enhance patient care. Unlike standard heart failure treatments, which often rely on medication and lifestyle changes, this trial tests a digital decision-making app that provides personalized risk information tailored to each patient. This app empowers patients by involving them more directly in their health management and decision-making. Additionally, one arm of the trial explores the impact of providing personalized risk information, while the other does not, allowing researchers to assess the value of personalization in digital health tools. By evaluating these approaches, researchers hope to discover more effective ways to engage patients and improve heart failure outcomes.

What evidence suggests that this digital decision-making app is effective for heart failure patients?

Previous studies have shown that digital tools improve heart failure care by supporting shared decision-making between patients and doctors. Research shows that personalized risk information helps patients understand their options and feel more satisfied with their care. In this trial, participants will use a digital decision-making app either with or without personalized risk information, while some will receive usual clinical care without the app. These digital tools can also help start and adjust treatments for heart failure, potentially lowering the risk of sudden heart-related issues. Shared decision-making is linked to better heart health because it customizes treatments to each person's needs. Telemonitoring apps have shown promise in improving quality of life and reducing hospital visits for heart failure patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Randall S Stafford, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for heart failure patients aged 70 or older with severe ischemic or nonischemic dilated cardiomyopathy, NYHA Class II or III. They must understand English, Mandarin, or Spanish and be able to follow instructions. Candidates should meet criteria for ICD placement with a Left Ventricular Ejection Fraction (LVEF) below 35%.

Inclusion Criteria

My participation may involve different criteria to improve the study.

My heart's pumping ability is significantly reduced.

I am 70 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Testing

Participants engage in interviews, focus groups, and surveys to develop and test the digital decision-making app

3 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for decisional conflict and app usability after using the digital tool

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Online, patient-facing decision-making aid (app) with personalized risk information

Trial Overview The study is developing a digital app to aid in decision-making about getting an Implantable Cardioverter Defibrillator (ICD). It will compare the effectiveness of this app providing personalized risk information versus one without it against usual care in future trials.

How Is the Trial Designed?

Group I: Use of a digital decision-making app without personalized risk information. Experimental Treatment 2 Interventions

The participant will use the pre-visit, participant-facing app without personal risk information. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool.

Group II: Exposure to digital decision-making app with personal risk information Experimental Treatment 2 Interventions

The participant will use the pre-visit, participant-facing app with personal risk information derived from participant characteristics. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool that displays the same personalized information.

Group III: Usual clinical care Placebo Group 1 Intervention

Participant will receive usual clinical care without use of the digital decision-making app.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

East Carolina University

Collaborator

Trials

111

Recruited

42,400+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9890083/

What helps the successful implementation of digital ... This study aims to systematically review the predictors of successful implementation of digital DAs for cardiovascular diseases.

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001162

Shared Decision-Making and Cardiovascular Health This scientific statement shines a light on the limited but growing body of evidence of the impact of shared decision-making on cardiovascular outcomes.

3. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(24)00158-4/fulltext

Digital tools in heart failure: addressing unmet needs This Series paper provides an overview of digital tools in heart failure care, encompassing screening, early diagnosis, treatment initiation and optimisation, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07084142?term=heart+disease

Developing a Digital Aid to Improve ICD Decisions The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9845822/

Effectiveness of mobile telemonitoring applications in heart ... This study aims to evaluate the impact of telemonitoring apps on mortality, hospitalization, and quality of life (QoL) in HF patients.

6. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.100981

Shared Decision-Making in Multidisciplinary Team-Based ... In this Expert Panel perspective, we review the current state of SDM in team-based cardiovascular care and propose best practice recommendations.