Effects of Remote Patient Monitoring on Heart Failure Management

September 29, 2010 updated by: University Health Network, Toronto

Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: heart failure remote patient monitoring system
remote monitoring of weight, blood pressure, ECG, and symptoms
No Intervention: control
group of patients provided with usual care at the University Health Network Heart Failure Clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain Natriuretic Peptide values
Time Frame: Baseline, 6 months
Baseline, 6 months
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Time Frame: baseline, 6 months
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
baseline, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Heather J Ross, MD, MHSc, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

September 30, 2010

Last Update Submitted That Met QC Criteria

September 29, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF-RPM-UHN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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