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

NCT ID: NCT05647317

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2024-04-15

Brief Summary

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

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Digital technology-based system for heart failure management

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

Group Type: OTHER

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

Intervention Type: OTHER

A combination of a provider-facing desktop and mobile application with a patient-facing mobile application that is integrated with a remote blood pressure cuff, heart rate monitor, and scale.

Interventions

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

A combination of a provider-facing desktop and mobile application with a patient-facing mobile application that is integrated with a remote blood pressure cuff, heart rate monitor, and scale.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alexander Sandhu

Instructor, CVMed, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex Sandhu, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Hospital & Clinics

Stanford, California, United States

Countries

United States

Central Contacts

Alexander Sandhu, MD

Role: CONTACT

ats114@stanford.edu

650 7234000

Karma Lhamo, MS

Role: CONTACT

karmalh@stanford.edu

9713362450

Facility Contacts

Alexander Sandhu, MD

Role: primary

Other Identifiers

67924

Identifier Type: -

Identifier Source: org_study_id