Heart FailureNCT00247000
A Strategy of Home Telehealth for Management of Congestive Heart Failure(STARTEL)
A study testing Routine Care in a HF clinic vs Home Telehealth Care for HF in people with Heart Failure, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Routine Care in a HF clinic vs Home Telehealth Care for HF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
New Brunswick Heart Centre, Atlantic Health Sciences Corporation
Saint John, New Brunswick, B2L 4L2
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Routine Care in a HF clinic vs Home Telehealth Care for HF
- Keywords
- Cardiovascular Diseases, Heart Disease, Heart Failure,Congestive, Health Outcomes, Disease Management, Telehomecare, Home Telehealth
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Care in a HF clinic vs Home Telehealth Care for HFDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Home teleheatlh for heart failure management Receives: Device: Routine Care in a HF clinic vs Home Telehealth Care for HF |
| 2 | Active comparator | Usual care for the management of Heart Failure Receives: Device: Routine Care in a HF clinic vs Home Telehealth Care for HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of total all-cause hospitalizations and total mortality at one year.
Measured: 1 year
Secondary outcomes (11)
Heart failure morbidity and mortality
Measured: 1 year
Cardiovascular hospitalization
Measured: 1 year
Total number days in hospital
Measured: 1 year
Total outpatient physician visits
Measured: 1 year
Number of non-scheduled health visits outside the home
Measured: 1 year
Total inpatient and outpatient health care costs
Measured: 1 year
Kansas City Cardiomyopathy Quality of Life Score
Measured: 1 year
Total medication related costs
Measured: 1 year
Medication adherence(by prescription filling data)
Measured: 1 year
Patient satisfaction as measured on Likert scale(1-10)
Measured: 1 year
Primary care physician satisfaction (Likert scale)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Atlantic Health Sciences Corporation, Heart and Stroke Foundation of Canada, Canada Health Infoway, Continuing Care Nova Scotia, Nova Scotia Telehealth Program, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Jonathan G Howlett, M.D.,FRCPC, Principal investigator, Capital District Health Authority, QEII Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247000
- Sponsor's protocol ID
- CDHA005
- Status last verified
- Feb 2006
- First submitted
- 30 Oct 2005
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Strategy of Home Telehealth for Management of Congestive Heart Failure: STARTEL
- ClinicalTrials.gov ID
- NCT00247000
- Acronym / sponsor ID
- CDHA005
- Conditions
- Heart Failure
- Keywords
- Cardiovascular Diseases, Heart Disease, Heart Failure,Congestive, Health Outcomes, Disease Management, Telehomecare, Home Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Atlantic Health Sciences Corporation, Heart and Stroke Foundation of Canada, Canada Health Infoway, Continuing Care Nova Scotia, Nova Scotia Telehealth Program, AstraZeneca
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Routine Care in a HF clinic vs Home Telehealth Care for HFHome teleheatlh for heart failure management |
| 2 | Active comparator | Device: Routine Care in a HF clinic vs Home Telehealth Care for HFUsual care for the management of Heart Failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Care in a HF clinic vs Home Telehealth Care for HF | Device | 1, 2 |
Primary outcome
A composite of total all-cause hospitalizations and total mortality at one year.
Time frame: 1 year
11 secondary outcomes
Heart failure morbidity and mortality
Time frame: 1 year
Cardiovascular hospitalization
Time frame: 1 year
Total number days in hospital
Time frame: 1 year
Total outpatient physician visits
Time frame: 1 year
Number of non-scheduled health visits outside the home
Time frame: 1 year
Total inpatient and outpatient health care costs
Time frame: 1 year
Kansas City Cardiomyopathy Quality of Life Score
Time frame: 1 year
Total medication related costs
Time frame: 1 year
Medication adherence(by prescription filling data)
Time frame: 1 year
Patient satisfaction as measured on Likert scale(1-10)
Time frame: 1 year
Primary care physician satisfaction (Likert scale)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan G Howlett, M.D.,FRCPC principal investigator
Capital District Health Authority, QEII Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care in a HF clinic vs Home Telehealth Care for HF in people with Heart Failure, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of total all-cause hospitalizations and total mortality at one year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.