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

Stanford University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Other: A combination of a provider-facing desktop and mobile application with a patient-facing mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT05647317

67924

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Digital technology-based system for heart failure management

Other group

Description:

This is a single-arm study to assess the feasibility and preliminary effectiveness of a digital technology-based system for heart failure management

Treatment:

Other: A combination of a provider-facing desktop and mobile application with a patient-facing mobile application