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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remote monitoring | Experimental | 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 |
|
| control | No Intervention | group of patients provided with usual care at the University Health Network Heart Failure Clinic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heart failure remote patient monitoring system | Device | remote monitoring of weight, blood pressure, ECG, and symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain Natriuretic Peptide values | Baseline, 6 months | |
| Self-care practices measured through Self-Care of Heart Failure Index scores and interviews | baseline, 6 months | |
| Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews | baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospitalizations and days in hospital | 6 months comparison between intervention and control groups | |
| Number of Emergency Department visits | 6 month comparison between intervention and control groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather J Ross, MD, MHSc | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22465288 | Derived | 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. | |
| 22356799 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| All cause mortality | 6 month comparison between intervention and control groups |
| Number of Heart Failure Clinic visits | 6 month comparison between intervention and control groups |