Effects of Remote Patient Monitoring on Heart Failure Management

Overview

The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.

Full Title of Study: “Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2010

Detailed Description

Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.

Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.

Interventions

  • Device: heart failure remote patient monitoring system
    • remote monitoring of weight, blood pressure, ECG, and symptoms

Arms, Groups and Cohorts

  • Experimental: remote monitoring
    • group of patients that will be using the heart failure remote patient monitoring system in addition to the usual care they receive at the University Health Network Heart Failure Clinic
  • No Intervention: control
    • group of patients provided with usual care at the University Health Network Heart Failure Clinic

Clinical Trial Outcome Measures

Primary Measures

  • Brain Natriuretic Peptide values
    • Time Frame: Baseline, 6 months
  • Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
    • Time Frame: baseline, 6 months
  • Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
    • Time Frame: baseline, 6 months

Secondary Measures

  • Number of hospitalizations and days in hospital
    • Time Frame: 6 months comparison between intervention and control groups
  • Number of Emergency Department visits
    • Time Frame: 6 month comparison between intervention and control groups
  • All cause mortality
    • Time Frame: 6 month comparison between intervention and control groups
  • Number of Heart Failure Clinic visits
    • Time Frame: 6 month comparison between intervention and control groups

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of Heart Failure (NYHA Class II-IV)
  • Out-patients attending the University Health Network Heart Failure Clinic
  • English-speaking and able to read English
  • 18 years old or over

Exclusion Criteria

  • Awaiting heart transplantation
  • Not expected to survive over a year (as determined by their cardiologist)
  • Unable to read text on a mobile phone due to vision disability
  • Unable to self-care due to anxiety, depression, or decreased cognitive function
  • Lack of manual dexterity to accurately press buttons on the mobile phone

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Heather Ross, University Health Network
  • Overall Official(s)
    • Heather J Ross, MD, MHSc, Principal Investigator, University Health Network, Toronto

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