Effects of Remote Patient Monitoring on Heart Failure Management
NCT ID: NCT00778986
Last Updated: 2010-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2009-03-31
2010-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
heart failure remote patient monitoring system
remote monitoring of weight, blood pressure, ECG, and symptoms
control
group of patients provided with usual care at the University Health Network Heart Failure Clinic
No interventions assigned to this group
Interventions
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heart failure remote patient monitoring system
remote monitoring of weight, blood pressure, ECG, and symptoms
Eligibility Criteria
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Inclusion Criteria
* Out-patients attending the University Health Network Heart Failure Clinic
* English-speaking and able to read English
* 18 years old or over
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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University Health Network
Principal Investigators
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Heather J Ross, MD, MHSc
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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References
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Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556-65. doi: 10.1016/j.ijmedinf.2012.03.001. Epub 2012 Mar 31.
Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
Other Identifiers
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HF-RPM-UHN
Identifier Type: -
Identifier Source: org_study_id