COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247000
Recruitment Status : Unknown
Verified February 2006 by Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2005
Last Update Posted : June 28, 2007
Atlantic Health Sciences Corporation
Heart and Stroke Foundation of Canada
Canada Health Infoway
Department of Health, Nova Scotia
Continuing Care Nova Scotia
Nova Scotia Telehealth Program
Information provided by:
Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Routine Care in a HF clinic vs Home Telehealth Care for HF Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Strategy of Home Telehealth for Management of Congestive Heart Failure: STARTEL
Study Start Date : September 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. A composite of total all-cause hospitalizations and total mortality at one year.

Secondary Outcome Measures :
  1. Heart failure morbidity and mortality
  2. Cardiovascular hospitalization
  3. Total number days in hospital
  4. Total outpatient physician visits
  5. Number of non-scheduled health visits outside the home
  6. Total inpatient and outpatient health care costs
  7. Kansas City Cardiomyopathy Quality of Life Score
  8. Total medication related costs
  9. Medication adherence(by prescription filling data)
  10. Patient satisfaction as measured on Likert scale(1-10)
  11. Primary care physician satisfaction (Likert scale)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247000

Layout table for location contacts
Contact: Jonathan G Howlett, M.D.,FRCPC 902-473-7871
Contact: Michelle T Currie, RN 902-473-7745

Layout table for location information
Canada, New Brunswick
New Brunswick Heart Centre, Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, B2L 4L2
Contact: Krisan Palmer, RN    506-648-7342   
Sub-Investigator: David Marr, M.D.,FRCPC         
Sponsors and Collaborators
Nova Scotia Health Authority
Atlantic Health Sciences Corporation
Heart and Stroke Foundation of Canada
Canada Health Infoway
Department of Health, Nova Scotia
Continuing Care Nova Scotia
Nova Scotia Telehealth Program
Layout table for investigator information
Principal Investigator: Jonathan G Howlett, M.D.,FRCPC Capital District Health Authority, QEII Health Sciences Centre

Layout table for additonal information Identifier: NCT00247000    
Other Study ID Numbers: CDHA005
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: June 28, 2007
Last Verified: February 2006
Keywords provided by Nova Scotia Health Authority:
Cardiovascular Diseases
Heart Disease
Heart Failure,Congestive
Health Outcomes
Disease Management
Home Telehealth
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases