Heart Failure
Conditions
Keywords
Cardiovascular Diseases, Heart Disease, Heart Failure,Congestive, Health Outcomes, Disease Management, Telehomecare, Home Telehealth
Brief summary
To demonstrate the safety, feasibility, quality of life, primary caregiver satisfaction, and cost effectiveness of integrated Home Telehealth care versus standard care in a heart failure clinic.
Detailed description
We plan to implement and evaluate a Home Telehealth Care Management System designed to enhance clinical care for congestive heart failure patients who have difficulty with access to care. Unique in this model is that in addition to use of protocol driven interventions (evidence based), the primary care physician is intimately involved in follwo up of patients- with consequent reduction in the fracture of care seen in with attendance in multiple specialty clinics. In this project, we will evaluate the delivery of care to heart failure patients in Nova Scotia and New Brunswick, with our intervention and the current standard of care, which is the heart failure clinic. Home Telehealth technology will allow patients to be contacted and regularly evaluated in a comprehensive way in their own home, and without the need for a clinic visit. While the Project Team (experienced in heart failure management) will monitor all data, the Family Physician will have first hand access to and right of first treatment when alterations in therapy are needed. This process will be facilitated by the use of protocol driven medical therapy, and delegated medical functions, as well as set-piece education. We hope, with this technology and care plan, to offer the benefits of disease management to this vulnerable patient population while at the same time firmly placing the Family Physician in their central role within the health care system. This program will enable a specific assessment of all aspects of the program, including outcomes, quality of life, professional satisfaction and cost.
Interventions
DEVICERoutine Care in a HF clinic vs Home Telehealth Care for HF
Sponsors
Atlantic Health Sciences Corporation
Heart and Stroke Foundation of Canada
Canada Health Infoway
Continuing Care Nova Scotia
Nova Scotia Telehealth Program
AstraZeneca
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patient Population Inclusion Criteria: Patients are eligible for participating in STARTEL if they satisfy all of the following inclusion criteria. 1. Male or female subject's ≥ 18 years of age with a diagnosis of Heart Failure 2. Subject must reside in either the Province of Nova Scotia or New Brunswick 3. Subject has been hospitalized for heart failure during the past two years or has a known history of heart failure for a minimum of two years. 4. Subject must have a dedicated working telephone line in their primary place of residence. 5. Subject must have a grounded electrical power supply in their primary place of residence. 6. Primary care physician provides their agreement to participate in STARTEL
Exclusion criteria
Patients are not eligible for participating in STARTEL if they meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of total all-cause hospitalizations and total mortality at one year. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Kansas City Cardiomyopathy Quality of Life Score | 1 year |
| Total medication related costs | 1 year |
| Medication adherence(by prescription filling data) | 1 year |
| Patient satisfaction as measured on Likert scale(1-10) | 1 year |
| Primary care physician satisfaction (Likert scale) | 1 year |
| Total inpatient and outpatient health care costs | 1 year |
| Cardiovascular hospitalization | 1 year |
| Total number days in hospital | 1 year |
| Total outpatient physician visits | 1 year |
| Number of non-scheduled health visits outside the home | 1 year |
| Heart failure morbidity and mortality | 1 year |
Countries
Canada
Outcome results
None listed