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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Simon Fraser University
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Scott Lear, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01342276
First received: April 25, 2011
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.

Hypotheses

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 Intervention
Heart Failure
Behavioral: vHFC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using the Internet for Self-management and Monitoring Patients With Heart Failure at a Distance

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

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


Secondary Outcome Measures:
  • Self-management skills [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessed using the Minnesota Living with Heart Failure questionnaire.

  • B-type natriuretic peptide [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Health care utilization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Physician visits, lab and diagnostic procedures, hospitalizations and clinical events.

  • Medication use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessed by patient interview.

  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Lifestyle [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Participant adherence to the vHFC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessed through website use (logins) and completion of data entry.


Estimated Enrollment: 186
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342276

Contacts
Contact: Scott A Lear, PhD 778-782-7916 SLear@providencehealth.bc.ca

Locations
Canada, British Columbia
University Hospital of Northern British Columbia Recruiting
Prince George, British Columbia, Canada, V2M 1S2
Contact: Tara Wong, BSc    250-564-4422 ext 238    twong@bcatpr.ca   
Sub-Investigator: Suzanne Johnston, MD         
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Kaitey Vincent    604-806-8242    KVincent2@providencehealth.bc.ca   
Sub-Investigator: Annemarie Kaan, RN         
Sponsors and Collaborators
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Scott A Lear, PhD Simon Fraser University
  More Information

No publications provided

Responsible Party: Scott Lear, Associate Professor, Simon Fraser University
ClinicalTrials.gov Identifier: NCT01342276     History of Changes
Other Study ID Numbers: 711207
Study First Received: April 25, 2011
Last Updated: August 16, 2012
Health Authority: Canada: Simon Fraser University
Canada: Northern Health Authority
Canada: Providence Health Care

Keywords provided by Simon Fraser University:
Heart failure
Self-management
Telehealth
Internet

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014