Effects of Remote Patient Monitoring on Heart Failure Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Device: heart failure remote patient monitoring system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remote monitoring<br>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<br>* remote monitoring of weight, blood pressure, ECG, and symptoms<br>|
| No Intervention: control<br>group of patients provided with usual care at the University Health Network Heart Failure Clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, remote patient monitoring, telemonitoring, home monitoring, randomized controlled trial, self care