Effects of Remote Patient Monitoring on Heart Failure Management

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00778986
First received: October 23, 2008
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Heart Failure
Device: heart failure remote patient monitoring system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Brain Natriuretic Peptide values [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Self-care practices measured through Self-Care of Heart Failure Index scores and interviews [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of hospitalizations and days in hospital [ Time Frame: 6 months comparison between intervention and control groups ] [ Designated as safety issue: No ]
  • Number of Emergency Department visits [ Time Frame: 6 month comparison between intervention and control groups ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 6 month comparison between intervention and control groups ] [ Designated as safety issue: No ]
  • Number of Heart Failure Clinic visits [ Time Frame: 6 month comparison between intervention and control groups ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778986

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Heather J Ross, MD, MHSc University Health Network, Toronto
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heather Ross, University Health Network
ClinicalTrials.gov Identifier: NCT00778986     History of Changes
Other Study ID Numbers: HF-RPM-UHN
Study First Received: October 23, 2008
Last Updated: September 29, 2010
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
heart failure
remote patient monitoring
telemonitoring
home monitoring
randomized controlled trial
self care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014