Trial of an Internet-based Platform for Monitoring Heart Failure Patients (vHFC)
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:
- To establish a cohort of 186 patients with HF.
- To determine the benefits of participating in the vHFC over usual care at 12 months with respect to exercise capacity.
- To compare the changes in other risk factors and lifestyle behaviours between the vHFC and usual care patients.
|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|
- 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.
- 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.
|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)|
Patients will get to participate in the interactive heart failure website (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).
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Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Scott A Lear, PhD||Simon Fraser University|