Effects of Remote Patient Monitoring on Heart Failure Management
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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 |
- 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 ]
- 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 |
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| Canada, Ontario | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| 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 May 19, 2013