Using the Internet for Self-management and Monitoring Patients With Heart Failure at a Distance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Simon Fraser University
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Functional capacity
Study Overview
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:
- 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.
Detailed Description
Consecutive cardiac in-patients of the University Hospital of Northern BC in Prince George and of St. Paul's Hospital in Vancouver will be screened for the Inclusion/Exclusion Criteria. Those who meet the criteria will undergo the baseline assessment.
The baseline assessment will include collecting information on social demographics, (including age, gender, education level, and socioeconomic data) medical history, 6-minute walk test, self-management and quality of life, fasting blood test, medication use, HF severity classification, blood pressure, and lifestyle (physical activity, smoking status, alcohol consumption). Following baseline assessment, patients will be stratified by sex and randomized to either the vHFC or usual care.
Usual Care Group:
Participants randomized to usual care will be given educational information explaining what HF is, the importance of salt and fluid restriction, a form to log their weight and a list of Internet-based resources.There will be no contact between the study personnel and the usual care participants for the duration of the study, nor will there be any attempt to control for the level of patient care. Participants will return at 12 months for outcome assessment.
Intervention Group:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
vHFC
Patients will get to participate in the interactive heart failure website (vHFC).
Intervention: vHFC (Behavioral)
Usual Care
Patients will not get to participate in the interactive heart failure website (vHFC).
Outcomes
Primary Outcomes
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 Outcomes
- B-type natriuretic peptide(12 months)
- Quality of life(12 months)
- Blood pressure(12 months)
- Participant adherence to the vHFC(12 months)
- Self-management skills(12 months)
- Medication use(12 months)
- Health care utilization(12 months)
- Lifestyle(12 months)
Investigators
Scott Lear
Associate Professor
Simon Fraser University