Heart FailureTEC4HomeNCT03439384
TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care
A study testing Home Telemonitoring in people with Heart Failure, run by University of British Columbia at 1 site in Canada.
Trial summary
TEC4Home Heart Failure is a randomized controlled trial (RCT) that examines how home health monitoring (HHM) can support Heart Failure (HF) patients during the transition of care from hospital to home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Home Telemonitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 19 years of age or older (age of majority in British Columbia)
- Have one or more typical symptoms of Heart Failure (i.e. dyspnoea at rest or minimal exertion (includes orthopnoea, reduced exercise tolerance)) AND
- Have one or more typical signs of Heart Failure (i.e. elevated jugular venous pressure, pulmonary crepitations, pleural effusions, peripheral oedema) AND
- Have one or more objective measures of heart failure:
- Radiological congestion.
- Elevated BNP ≥ 400 pg/mL or NT-proBNP ≥ 1000 pg/mL.
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- Reduced left ventricular ejection fraction <40% (or <45%) in previous 12 months.
- Diastolic dysfunction including tissue Doppler E/e' ratio > 15 in previous 12 months.
- Pulmonary capillary wedge pressure >20 mmHg.
- Diuretic therapy. The additional value of diuretic therapy (IV or oral) is debatable, as presumably unlikely (or unsafe) that patient with genuine HF will be discharged without diuretic.
Who cannot join
- Physical barriers e.g. unable to stand on scales.
- Cognitive impairment (e.g. MMSE <20), unless suitable caregiver support.
- Language (must be able to read and understand English), unless suitable caregiver support.
- Documented history of current and active substance misuse (within 3 months).
- Lack digital connectivity or landline phone connection.
- No regular care provider e.g. GP, or at least regular walk-in clinic.
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- Existing intensive system of care: LVAD, transplant, dialysis.
- Anticipated improvement due to revascularization (PCI/CABG) or valve intervention during index hospitalization.
- Anticipated survival <90 days. Active palliative care, less-than level III care, disseminated malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
TEC4Home Heart Failure is a randomized controlled trial (RCT) that examines how home health monitoring (HHM) can support Heart Failure (HF) patients during the transition of care from hospital to home. The HHM solution includes a weight scale, blood pressure cuff, pulse oximeter and tablet computer, which patients use daily for 60 days to record these metrics and answer questions on their symptoms. This data is sent to a nurse who is able to monitor the patient's condition remotely. The hypothesis is that the TEC4Home HHM solution will be a cost-effective strategy to decrease 90-day Emergency Department (ED) revisits and hospital admission rates, and improve quality of life and self-management for patients living with Heart Failure.
- Conditions
- Heart Failure
- Being tested
- Home Telemonitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home TelemonitoringDevice
Patients will monitor their weight, blood pressure, oxygen saturation and symptoms with sensors and a tablet computer provided to them. Patients are asked to do this everyday for 60-days. A monitoring nurse will be receiving the data electronically and reviewing on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Home Telemonitoring | Experimental | Patients will receive home telemonitoring equipment and monitor their health for 60 days post-enrollment. A monitoring nurse will receive and review the patients health data on a daily basis for the 60 day duration and provide remote care, counseling and education. Receives: Device: Home Telemonitoring |
| Control: No Home Telemonitoring | No intervention | The patient will not receive any home telemonitoring once enrolled and will continue to receive the usual care he/she can expect as part of his/her care plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
Hospital administrative data will be reviewed to assess the change in the number of emergency department visits 90 day pre to 90 days post enrollment and between study groups.
Measured: 90 days
Change in the number of hospitalizations 90 days pre to 90 days post enrollment.
Hospital administrative data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment and between study groups.
Measured: 90 days
Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment.
Hospital administrative data will be reviewed to assess the change in length of stay (measured in days) 90 day pre and 90 days post enrollment and between study groups.
Measured: 90 days
Mortality rate
Administrative will be reviewed to determine the number of participants who passed away between study groups.
Measured: 90 days
Secondary outcomes (6)
Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D).
A 5 item generic health-related quality of life questionnaire to be administered to all participants for comparison pre-post enrollment and between study groups.
Measured: 90 days
Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale.
A 12 item disease-specific quality of life questionnaire will be administered to all participants for comparison pre-post enrollment and between study groups.
Measured: 90 days
Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale.
A 9 item scale to asses a patient's self-care behaviours and attitudes specific to Heart Failure will be administered to all participants for comparison pre-post enrollment and between study groups.
Measured: 90 days
Difference in costs and savings via administrative data and a self-report healthcare utilization survey.
Costs related to healthcare utilization and other health-related out of pocket and system costs will be assessed and compared 90 days pre to 90 days post enrollment and between study groups.
Measured: 90 days
Impact on communication between healthcare providers and patients via surveys.
Surveys about end-user experience will be used to collect feedback from patient participants, nurses and other healthcare providers involved to understand the impact of home health monitoring on communication during the transition of care.
Measured: 90 days
Impact on communication between healthcare providers and patients via interviews.
Interviews about end-user experience will be used to collect feedback from patient participants, nurses and other healthcare providers involved to understand the impact of home health monitoring on communication during the transition of care.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Aug 2018
- Primary completionJun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A stepped wedge trial design was used to cluster and randomize recruiting sites into a schedule as to when sites would enroll participants into the control or intervention group.
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kendall Ho, University of British Columbia
- Investigators
- Kendall Ho, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439384
- Sponsor's protocol ID
- H17-02846
- Acronym
- TEC4Home
- Status last verified
- Mar 2020
- First submitted
- 16 Jan 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ho K, Novak Lauscher H, Cordeiro J, Hawkins N, Scheuermeyer F, Mitton C, Wong H, McGavin C, Ross D, Apantaku G, Karim ME, Bhullar A, Abu-Laban R, Nixon S, Smith T. Testing the Feasibility of Sensor-Based Home Health Monitoring (TEC4Home) to Support the Convalescence of Patients With Heart Failure: Pre-Post Study. JMIR Form Res. 2021 Jun 3;5(6):e24509. doi: 10.2196/24509.
PubMed 34081015
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
- ClinicalTrials.gov ID
- NCT03439384
- Acronym / sponsor ID
- TEC4Home / H17-02846
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Feb 2018 (actual)
- 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.
TEC4Home Heart Failure is a randomized controlled trial (RCT) that examines how home health monitoring (HHM) can support Heart Failure (HF) patients during the transition of care from hospital to home. The HHM solution includes a weight scale, blood pressure cuff, pulse oximeter and tablet computer, which patients use daily for 60 days to record these metrics and answer questions on their symptoms. This data is sent to a nurse who is able to monitor the patient's condition remotely. The hypothesis is that the TEC4Home HHM solution will be a cost-effective strategy to decrease 90-day Emergency Department (ED) revisits and hospital admission rates, and improve quality of life and self-management for patients living with Heart Failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped wedge trial design was used to cluster and randomize recruiting sites into a schedule as to when sites would enroll participants into the control or intervention group.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Home Telemonitoring | Experimental | Device: Home TelemonitoringPatients will receive home telemonitoring equipment and monitor their health for 60 days post-enrollment. A monitoring nurse will receive and review the patients health data on a daily basis for the 60 day duration and provide remote care, counseling and education. |
| Control: No Home Telemonitoring | No intervention | –The patient will not receive any home telemonitoring once enrolled and will continue to receive the usual care he/she can expect as part of his/her care plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be 19 years of age or older (age of majority in British Columbia)
- Have one or more typical symptoms of Heart Failure (i.e. dyspnoea at rest or minimal exertion (includes orthopnoea, reduced exercise tolerance)) AND
- Have one or more typical signs of Heart Failure (i.e. elevated jugular venous pressure, pulmonary crepitations, pleural effusions, peripheral oedema) AND
- Have one or more objective measures of heart failure:
- Radiological congestion.
Key exclusion criteria (9 listed)
- Physical barriers e.g. unable to stand on scales.
- Cognitive impairment (e.g. MMSE <20), unless suitable caregiver support.
- Language (must be able to read and understand English), unless suitable caregiver support.
- Documented history of current and active substance misuse (within 3 months).
- Lack digital connectivity or landline phone connection.
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 |
|---|---|---|
| Home TelemonitoringPatients will monitor their weight, blood pressure, oxygen saturation and symptoms with sensors and a tablet computer provided to them. Patients are asked to do this everyday for 60-days. A monitoring nurse will be receiving the data electronically and reviewing on a daily basis. | Device | Experimental: Home Telemonitoring |
Primary outcome
Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
Time frame: 90 days
Hospital administrative data will be reviewed to assess the change in the number of emergency department visits 90 day pre to 90 days post enrollment and between study groups.
Change in the number of hospitalizations 90 days pre to 90 days post enrollment.
Time frame: 90 days
Hospital administrative data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment and between study groups.
Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment.
Time frame: 90 days
Hospital administrative data will be reviewed to assess the change in length of stay (measured in days) 90 day pre and 90 days post enrollment and between study groups.
Mortality rate
Time frame: 90 days
Administrative will be reviewed to determine the number of participants who passed away between study groups.
6 secondary outcomes
Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D).
Time frame: 90 days
Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale.
Time frame: 90 days
Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale.
Time frame: 90 days
Difference in costs and savings via administrative data and a self-report healthcare utilization survey.
Time frame: 90 days
Impact on communication between healthcare providers and patients via surveys.
Time frame: 90 days
Impact on communication between healthcare providers and patients via interviews.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 34081015Ho K, Novak Lauscher H, Cordeiro J, Hawkins N, Scheuermeyer F, Mitton C, Wong H, McGavin C, Ross D, Apantaku G, Karim ME, Bhullar A, Abu-Laban R, Nixon S, Smith T. Testing the Feasibility of Sensor-Based Home Health Monitoring (TEC4Home) to Support the Convalescence of Patients With Heart Failure: Pre-Post Study. JMIR Form Res. 2021 Jun 3;5(6):e24509. doi: 10.2196/24509.
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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.
Kendall Ho, MD FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Telemonitoring in people with Heart Failure, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. 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?
Results are not available in the source record.
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?
Change in the number of emergency department visits 90 days pre to 90 days post enrollment. (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439384, which also lists 1 linked publication.
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 24 Mar 2020.