Clinical trial NCT00778986: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
remote patient monitoring
telemonitoring
home monitoring
randomized controlled trial
self care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Brain Natriuretic Peptide values
timeFrame: Baseline, 6 months
measure: Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
timeFrame: baseline, 6 months
measure: Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Number of hospitalizations and days in hospital
timeFrame: 6 months comparison between intervention and control groups
measure: Number of Emergency Department visits
timeFrame: 6 month comparison between intervention and control groups
measure: All cause mortality
timeFrame: 6 month comparison between intervention and control groups
measure: Number of Heart Failure Clinic visits
timeFrame: 6 month comparison between intervention and control groups
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Heather J Ross, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.