Trial of an Internet-based Platform for Monitoring Heart Failure Patients (vHFC)
This study is currently recruiting participants.
Verified August 2012 by Simon Fraser University
Sponsor:
Simon Fraser University
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
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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:
- 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.
| 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
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 May 19, 2013