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OpenTrials
Completed

NCT Number: NCT00778986

Effects of Remote Patient Monitoring on Heart Failure Management

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heart failure remote patient monitoring system

Device

remote monitoring of weight, blood pressure, ECG, and symptoms

Primary outcomes

  1. Brain Natriuretic Peptide values

    Time frame: Baseline, 6 months

  2. Self-care practices measured through Self-Care of Heart Failure Index scores and interviews

    Time frame: baseline, 6 months

  3. Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews

    Time frame: baseline, 6 months

Secondary outcomes

  1. Number of hospitalizations and days in hospital

    Time frame: 6 months comparison between intervention and control groups

  2. Number of Emergency Department visits

    Time frame: 6 month comparison between intervention and control groups

  3. All cause mortality

    Time frame: 6 month comparison between intervention and control groups

  4. Number of Heart Failure Clinic visits

    Time frame: 6 month comparison between intervention and control groups

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 24, 2008
Registry last updated
Sep 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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