Effects of Remote Patient Monitoring on Heart Failure Management

University Health Network, Toronto

Status: Completed

Conditions: Heart Failure

Treatments: Device: heart failure remote patient monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT00778986

HF-RPM-UHN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

remote monitoring

Experimental group

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

Treatment:

Device: heart failure remote patient monitoring system

control

No Intervention group

Description:

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