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Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
Previous research has investigated the use of remote patient monitoring in various clinical contexts, however there has not been a clinical trial examining use of the VitalCare platform for ambulatory management of heart failure. This trial will serve as a pilot study examining the feasibility of use of the VitalCare platform for ambulatory heart failure management and examine the effect of remote patient monitoring on patient engagement. To the investigators' knowledge, this will be the first study examining the effect of remote patient monitoring with the VitalCare platform on heart failure clinical outcomes, such as hospitalization for heart failure exacerbations and emergency room visits for heart failure.
Conditions:
🦠 Congestive Heart Failure
🗓️ Study Start (Actual) 1 August 2024
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 30 April 2026
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Kansas City, Kansas, United States
📍 Overland Park, Kansas, United States
📍 Kansas City, Missouri, United States
📍 Lee's Summit, Missouri, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * A clinical diagnosis of heart failure
    • * New York Heart Association Class II or III congestive HF symptoms
    • * Admission to hospital within 12 months for symptomatic heart failure.
    • * Own a smartphone or tablet or comfortable with using one
    • * English as primary language
    • * Able to provide informed consent

    Exclusion Criteria:

    • * Left Ventricular Ejection Fraction \< 35%
    • * Implanted cardiac device (permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), chronic resynchronization therapy (CRT), implantable loop recorder (ILR))
    • * CardioMEMS
    • * Left ventricular assist device (LVAD)
    • * NYHA Class I or IV congestive HF symptoms
    • * Listed for cardiac transplant
    • * Pregnant at time enrollment
    • * End-stage renal disease
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 March 2021
  • First Submitted that Met QC Criteria 8 June 2023
  • First Posted 12 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 June 2024
  • Last Update Posted 6 June 2024
  • Last Verified June 2024
I'm interested ...!!