A Strategy of Home Telehealth for Management of Congestive Heart Failure(STARTEL)

A Strategy of Home Telehealth for Management of Congestive Heart Failure: STARTEL

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Routine Care in a HF clinic vs Home Telehealth Care for HF

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, B2L 4L2
      • New Brunswick Heart Centre, Atlantic Health Sciences Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria.

1. Inability to understand the English or French language or understand the study and provide informed consent.
2. Absence of a suitable area to conduct the home telehealth visit in the patient's place of residence.
3. 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).
4. 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).
5. Subject has a planned cardiac procedure such as open-heart surgery or percutaneous coronary intervention (PCI) within the next 6 months.
6. Subject has had cardiac surgery, percutaneous coronary intervention or a diagnosis of acute myocardial infarction within 1 month before randomization).
7. Condition where existing routine follow up occurs more than once weekly (i.e. hemodialysis, cancer treatment including: chemotherapy/radiation treatment). .
8. Patient is institutionalized (includes chronic care facility)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Home teleheatlh for heart failure management	Device: Routine Care in a HF clinic vs Home Telehealth Care for HF
Active Comparator: 2; Usual care for the management of Heart Failure	Device: Routine Care in a HF clinic vs Home Telehealth Care for HF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A composite of total all-cause hospitalizations and total mortality at one year.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular hospitalization	1 year
Heart failure morbidity and mortality	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
Total inpatient and outpatient health care costs	1 year
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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: AstraZeneca; Heart and Stroke Foundation of Canada; Atlantic Health Sciences Corporation; Canada Health Infoway; Continuing Care Nova Scotia; Nova Scotia Telehealth Program
• Investigators: Principal Investigator: Jonathan G Howlett, M.D.,FRCPC, Capital District Health Authority, QEII Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 30, 2005
• First Submitted That Met QC Criteria: October 30, 2005
• First Posted (Estimate): November 1, 2005

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: February 1, 2006

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Heart Disease; Disease Management; Health Outcomes; Telehomecare; Home Telehealth; Heart Failure,Congestive
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CDHA005