Trial of an Internet-based Platform for Monitoring Heart Failure Patients (vHFC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01342276
Recruitment Status : Terminated (Due to futility of recruitment.)
First Posted : April 27, 2011
Last Update Posted : April 15, 2016
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Scott Lear, Simon Fraser University

Brief Summary:

Several studies have indicated that heart failure (HF) clinics facilitating patient self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and HF-related hospitalizations, all-cause mortality, and improve patient quality of life. Additionally, national and provincial organizations have identified patient-focused homecare initiatives in telehealth as demonstrating great promise for health service. Our pilot study demonstrated the feasibility of the internet based vHFC and supports the investigation of this intervention in patients with HF.

The purpose of our single-blinded randomized trail is to investigate the efficacy of an Internet-based heart failure (HF) clinic (vHFC) in 186 patients living with HF.


A. Participation in a vHFC emphasizing patient self-management and monitoring will result in improved functional capacity compared to usual care in patients with HF.

B. Participation in a vHFC emphasizing patient self-management and monitoring will result in improved health indices such as, self-management skills, quality of life, levels of B-type natriuretic peptide and healthcare utilization compared to usual care in patients with HF.

Our objectives of the vHFC study is as follows:

  1. To establish a cohort of 186 patients with HF.
  2. To determine the benefits of participating in the vHFC over usual care at 12 months with respect to exercise capacity.
  3. To compare the changes in other risk factors and lifestyle behaviours between the vHFC and usual care patients.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: vHFC Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using the Internet for Self-management and Monitoring Patients With Heart Failure at a Distance
Study Start Date : April 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: vHFC
Patients will get to participate in the interactive heart failure website (vHFC).
Behavioral: vHFC
Common practice for managing HF patients attending urban-based, specialized HF clinics is to have them weigh themselves daily and report any dramatic fluctuations and/or increasing symptoms to their clinic. We have transformed this model to the vHFC website such that each day, participants will logon to the vHFC and enter their weight and answer six questions regarding their current symptoms. An alert will be generated if the participant enters data outside of the desired parameters, does not enter their data for three consecutive days, or enters a comment in the text box for the vHFC nurse to view. If an alert is generated, following participant data entry, the participant is presented with a pop up window to inform them that the vHFC nurse will contact them within 24 hours. The nurse will contact the participant by telephone to discuss the alert generated and provide counselling.
No Intervention: Usual Care
Patients will not get to participate in the interactive heart failure website (vHFC).

Primary Outcome Measures :
  1. Functional capacity [ Time Frame: 12 months ]
    Assessed by measuring the distance walked during the 6-minute walk test following the guidelines of the American Thoracic Society.

Secondary Outcome Measures :
  1. Self-management skills [ Time Frame: 12 months ]
    Assessed using the Self-Care of Heart Failure Index, which measures a patient's ability to self-manage their condition, and consists of three domains: self-care confidence, maintenance and management.

  2. Quality of life [ Time Frame: 12 months ]
    Assessed using the Minnesota Living with Heart Failure questionnaire.

  3. B-type natriuretic peptide [ Time Frame: 12 months ]
  4. Health care utilization [ Time Frame: 12 months ]
    Physician visits, lab and diagnostic procedures, hospitalizations and clinical events.

  5. Medication use [ Time Frame: 12 months ]
    Assessed by patient interview.

  6. Blood pressure [ Time Frame: 12 months ]
  7. Lifestyle [ Time Frame: 12 months ]
    Leisure time physical activity is determined by the 4-week modified Minnesota LTPA questionnaire and smoking status and alcohol intake is assessed by self-report.

  8. Participant adherence to the vHFC [ Time Frame: 12 months ]
    Assessed through website use (logins) and completion of data entry.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • daily Internet access
  • able to provide informed consent
  • able to read, write and understand English without difficulty

Exclusion Criteria:

  • have significant co-morbidities that may interfere with effective HF management
  • reside in a nursing home
  • have a disability that precludes walking
  • patients in who it is foreseen will be unlikely to survive for the duration of the study or have scheduled surgical procedures that based on the opinion of their hospital attending physician should be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01342276

Canada, British Columbia
University Hospital of Northern British Columbia
Prince George, British Columbia, Canada, V2M 1S2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Scott A Lear, PhD Simon Fraser University

Responsible Party: Scott Lear, Associate Professor, Simon Fraser University Identifier: NCT01342276     History of Changes
Other Study ID Numbers: 711207
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Scott Lear, Simon Fraser University:
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases