Status:
COMPLETED
A Strategy of Home Telehealth for Management of Congestive Heart Failure(STARTEL)
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Atlantic Health Sciences Corporation
Heart and Stroke Foundation of Canada
Conditions:
Heart Failure
Eligibility:
All Genders
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- Patient Population Patients are eligible for participating in STARTEL if they satisfy all of the following inclusion criteria.
- Male or female subject's ≥ 18 years of age with a diagnosis of Heart Failure
- Subject must reside in either the Province of Nova Scotia or New Brunswick
- 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.
- Subject must have a dedicated working telephone line in their primary place of residence.
- Subject must have a grounded electrical power supply in their primary place of residence.
- Primary care physician provides their agreement to participate in STARTEL
Exclusion
- Patients are not eligible for participating in STARTEL if they meet any of the following exclusion criteria.
- Inability to understand the English or French language or understand the study and provide informed consent.
- Absence of a suitable area to conduct the home telehealth visit in the patient's place of residence.
- Physical impairment, which would prohibit the successful completion of a home telehealth visit, including attachment of the peripheral equipment (BP cuff, ability to stand on a scale, etc).
- In cases 1 \& 3 only: a live in caregiver whose presence may overcome these limitations may allow the patient to be included in the study, however, only the patient's next of kin or duly appointed guardian (with documentation and with patient assent) may provide informed consent to participate).
- Subject has a planned cardiac procedure such as open-heart surgery or percutaneous coronary intervention (PCI) within the next 6 months.
- Subject has had cardiac surgery, percutaneous coronary intervention or a diagnosis of acute myocardial infarction within 1 month before randomization).
- Condition where existing routine follow up occurs more than once weekly (i.e. hemodialysis, cancer treatment including: chemotherapy/radiation treatment). .
- Patient is institutionalized (includes chronic care facility)
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00247000
Start Date
November 1 2007
End Date
October 1 2012
Last Update
October 31 2022
Active Locations (1)
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1
New Brunswick Heart Centre, Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, B2L 4L2