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

NCT05647317 | Unknown

• 1 other identifier: 67924
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Heart Failure; Digital Health; Remote monitoring; Mobile Application

Outcome Measures

Primary Outcomes (3)

• Patient Acceptability of the intervention

  The proportion of patients who assess the DOT-HF intervention as an acceptable method of post-discharge heart failure management. This will be assessed during a semi-structured interview between individual participants and a trained interviewer.

  At Study completion (12-week follow-up visit)

• Patients' Engagement score

  A weighted proportion of requested actions completed by the patient. These actions include daily blood pressure measurements, daily weight assessment, daily health status assessment, biweekly KCCQ-12 assessment, and review of educational videos and health summary data. The minimum score is 0% and maximum score is 100%.

  At Study completion (12-week follow-up visit)

• Clinicians' Response to Notification

  The proportion of DOT-HF clinician notifications that lead to a clinician response over the 12-week follow-up period. Each of the clinician DOT-HF notifications are detailed below. These include notification of eligible therapy adjustment, worsening patient-reported health status, and weight gain. Eligible clinician actions include medication changes or new telephone, video, or in-person clinic encounters in response to the notification.

  At Study completion (12-week follow-up visit)

Secondary Outcomes (11)

• Proportion of days with weight assessed

  At Study Completion (12-week follow-up visit)

• Proportion of days with daily health status completed

  At Study Completion (12-week follow-up visit)

• Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed

  At Study Completion (12-week follow-up visit)

• Proportion of days with blood pressure (systolic) assessed

  At Study Completion (12-week follow-up visit)

• Proportion of days with medication adherence assessed

  At Study Completion (12-week follow-up visit)

Study Arms (1)

Digital technology-based system for heart failure management

OTHER

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

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

Interventions

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

Digital technology-based system for heart failure management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital & Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alex Sandhu, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Sandhu, MD

CONTACT

650 7234000; ats114@stanford.edu

Karma Lhamo, MS

CONTACT

9713362450; karmalh@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, CVMed, Department of Medicine

Model Details: Single arm study

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 12, 2022
• Study Start: July 28, 2023
• Primary Completion: December 31, 2023
• Study Completion: April 15, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)