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Effects of Remote Patient Monitoring on Heart Failure Management

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
heart failure remote patient monitoring system
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, remote patient monitoring, telemonitoring, home monitoring, randomized controlled trial, self care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

remote monitoring

control

Arm Description

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

group of patients provided with usual care at the University Health Network Heart Failure Clinic

Outcomes

Primary Outcome Measures

Brain Natriuretic Peptide values
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews

Secondary Outcome Measures

Number of hospitalizations and days in hospital
Number of Emergency Department visits
All cause mortality
Number of Heart Failure Clinic visits

Full Information

First Posted
October 23, 2008
Last Updated
September 29, 2010
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00778986
Brief Title
Effects of Remote Patient Monitoring on Heart Failure Management
Official Title
Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, remote patient monitoring, telemonitoring, home monitoring, randomized controlled trial, self care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
remote monitoring
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
group of patients provided with usual care at the University Health Network Heart Failure Clinic
Intervention Type
Device
Intervention Name(s)
heart failure remote patient monitoring system
Intervention Description
remote monitoring of weight, blood pressure, ECG, and symptoms
Primary Outcome Measure Information:
Title
Brain Natriuretic Peptide values
Time Frame
Baseline, 6 months
Title
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Time Frame
baseline, 6 months
Title
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Number of hospitalizations and days in hospital
Time Frame
6 months comparison between intervention and control groups
Title
Number of Emergency Department visits
Time Frame
6 month comparison between intervention and control groups
Title
All cause mortality
Time Frame
6 month comparison between intervention and control groups
Title
Number of Heart Failure Clinic visits
Time Frame
6 month comparison between intervention and control groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather J Ross, MD, MHSc
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22465288
Citation
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.
Results Reference
derived
PubMed Identifier
22356799
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Remote Patient Monitoring on Heart Failure Management

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