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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Routine Care in a HF clinic vs Home Telehealth Care for HF
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiovascular Diseases, Heart Disease, Heart Failure,Congestive, Health Outcomes, Disease Management, Telehomecare, Home Telehealth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Population Inclusion Criteria: 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 Criteria: 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)

Sites / Locations

  • New Brunswick Heart Centre, Atlantic Health Sciences Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Home teleheatlh for heart failure management

Usual care for the management of Heart Failure

Outcomes

Primary Outcome Measures

A composite of total all-cause hospitalizations and total mortality at one year.

Secondary Outcome Measures

Heart failure morbidity and mortality
Cardiovascular hospitalization
Total number days in hospital
Total outpatient physician visits
Number of non-scheduled health visits outside the home
Total inpatient and outpatient health care costs
Kansas City Cardiomyopathy Quality of Life Score
Total medication related costs
Medication adherence(by prescription filling data)
Patient satisfaction as measured on Likert scale(1-10)
Primary care physician satisfaction (Likert scale)

Full Information

First Posted
October 30, 2005
Last Updated
October 26, 2022
Sponsor
Nova Scotia Health Authority
Collaborators
Atlantic Health Sciences Corporation, Heart and Stroke Foundation of Canada, Canada Health Infoway, Continuing Care Nova Scotia, Nova Scotia Telehealth Program, AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00247000
Brief Title
A Strategy of Home Telehealth for Management of Congestive Heart Failure(STARTEL)
Official Title
A Strategy of Home Telehealth for Management of Congestive Heart Failure: STARTEL
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Atlantic Health Sciences Corporation, Heart and Stroke Foundation of Canada, Canada Health Infoway, Continuing Care Nova Scotia, Nova Scotia Telehealth Program, AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiovascular Diseases, Heart Disease, Heart Failure,Congestive, Health Outcomes, Disease Management, Telehomecare, Home Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Home teleheatlh for heart failure management
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual care for the management of Heart Failure
Intervention Type
Device
Intervention Name(s)
Routine Care in a HF clinic vs Home Telehealth Care for HF
Primary Outcome Measure Information:
Title
A composite of total all-cause hospitalizations and total mortality at one year.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Heart failure morbidity and mortality
Time Frame
1 year
Title
Cardiovascular hospitalization
Time Frame
1 year
Title
Total number days in hospital
Time Frame
1 year
Title
Total outpatient physician visits
Time Frame
1 year
Title
Number of non-scheduled health visits outside the home
Time Frame
1 year
Title
Total inpatient and outpatient health care costs
Time Frame
1 year
Title
Kansas City Cardiomyopathy Quality of Life Score
Time Frame
1 year
Title
Total medication related costs
Time Frame
1 year
Title
Medication adherence(by prescription filling data)
Time Frame
1 year
Title
Patient satisfaction as measured on Likert scale(1-10)
Time Frame
1 year
Title
Primary care physician satisfaction (Likert scale)
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Population Inclusion Criteria: 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 Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan G Howlett, M.D.,FRCPC
Organizational Affiliation
Capital District Health Authority, QEII Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Brunswick Heart Centre, Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
B2L 4L2
Country
Canada

12. IPD Sharing Statement

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

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