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

NCT01342276 | Terminated

• 1 other identifier: 711207
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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

Conditions

Heart Failure

Keywords

Heart failure; Self-management; Telehealth; Internet

Outcome Measures

Primary Outcomes (1)

• Functional capacity

  Assessed by measuring the distance walked during the 6-minute walk test following the guidelines of the American Thoracic Society.

  12 months

Secondary Outcomes (8)

• Self-management skills

  12 months

• Quality of life

  12 months

• B-type natriuretic peptide

  12 months

• Health care utilization

  12 months

• Medication use

  12 months

Study Arms (2)

vHFC

EXPERIMENTAL

Patients will get to participate in the interactive heart failure website (vHFC).

Behavioral: vHFC

Usual Care

NO INTERVENTION

Patients will not get to participate in the interactive heart failure website (vHFC).

Interventions

vHFC BEHAVIORAL

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.

vHFC

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon Fraser University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

University Hospital of Northern British Columbia

Prince George, British Columbia, V2M 1S2, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Scott A Lear, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 27, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

CA (2)