NCT00778986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 30, 2010

Status Verified

September 1, 2010

Enrollment Period

1.5 years

First QC Date

October 23, 2008

Last Update Submit

September 29, 2010

Conditions

Heart Failure

Keywords

heart failureremote patient monitoringtelemonitoringhome monitoringrandomized controlled trialself care

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

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

Device: heart failure remote patient monitoring system

control

NO INTERVENTION

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

Interventions

heart failure remote patient monitoring systemDEVICE

remote monitoring of weight, blood pressure, ECG, and symptoms

remote monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years old or over

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 22465288DERIVED

  • 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.

    PMID: 22356799DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Heather J Ross, MD, MHSc

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 24, 2008

Study Start

March 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 30, 2010

Record last verified: 2010-09

Locations

CA(1)