Heart FailureTEC4HomeNCT02821065
Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
A study testing Remote Patient Monitoring in people with Heart Failure, run by University of British Columbia.
Trial summary
Modern technology like computers, smartphones and the Internet enable patients to measure certain health indicators, like blood pressure and body weight, from the comfort of their own homes. This information can also be shared electronically with doctors and other healthcare providers to monitor remotely. 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?
- Remote Patient Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2016to Nov 2017
- 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
- PATIENT PARTICIPANTS:
- 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.
- CLINICIAN PARTICIPANTS:
- To be eligible to participate, clinician participants (i.e. ED physicians, family physicians and monitoring nurse(s)) must have referred or have a patient enrolled in the TEC4Home monitoring service.
Who cannot join
- PATIENT PARTICIPANTS:
- 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.
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- No regular care provider e.g. GP, or at least regular walk-in clinic.
- 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.
- CLINICIAN PARTICIPANTS:
- Clinicians who do not have patients enrolled in the TEC4Home service or who themselves are not involved in the implementation or operation of the TEC4Home monitoring service will not be eligible to participate.
About this study
Official title: TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
Modern technology like computers, smartphones and the Internet enable patients to measure certain health indicators, like blood pressure and body weight, from the comfort of their own homes. This information can also be shared electronically with doctors and other healthcare providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are developing a home monitoring solution for patients with heart failure to support their care and recovery at home after a visit to the emergency department. We hope to show that this solution decreases revisits to the emergency department and increases quality of life for patients.
- Conditions
- Heart Failure
- Being tested
- Remote Patient Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient MonitoringDevice
| Study group | Role | What they receive |
|---|---|---|
| Home Telemonitoring | Experimental | 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 receives and reviews the data electronically and will follow-up with the patient. Receives: Device: Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of emergency department revisits 90 day pre and 90 days post enrollment.
Hospital administrative data and self-reported data will be reviewed to assess the number of emergency department visits 90 day pre and 90 days post enrollment.
Measured: 90 days
Change in the number of hospitalizations
Hospital administrative data and self-report data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment.
Measured: 90 days
Change in the length of stay (in days)
Hospital administrative data and self-report data will be reviewed to assess the length of stay (measured in days) 90 day pre and 90 days post enrollment.
Measured: 90 days
Mortality rate
The number of patients who pass away during the 90 day follow-up period will be recorded.
Measured: 90 days
Secondary outcomes (8)
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.
Measured: 90 days
Difference in quality of life (general) scores as assessed by the VR-12
A generic health-related quality of life questionnaire to be administered to all participants for comparison pre to post enrollment.
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.
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
Measured: 90 days
Impact of patient experience of care via surveys
Feedback from patients via survey questions to understand their experiences using the home health monitoring technology.
Measured: 90 days
Impact of patient experience of care via interviews
Feedback from patients via interview questions to understand their experiences using the home health monitoring technology.
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 posted1 Jul 2016 (estimated)
- Study start31 Oct 2016
- Primary completionNov 2017
- Study completionNov 2017
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, pre-post study design.
- Masking
- None (open label)
- Enrolment
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821065
- Sponsor's protocol ID
- H16-01076
- Acronym
- TEC4Home
- Status last verified
- Mar 2020
- First submitted
- 24 May 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
TEC4Home Healthcare Innovation Community. Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home). JMIR Res Protoc. 2016 Dec 18;5(4):e198. doi: 10.2196/resprot.5856.
PubMed 27977002
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
- NCT02821065
- Acronym / sponsor ID
- TEC4Home / H16-01076
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 1 Jul 2016 (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.
Modern technology like computers, smartphones and the Internet enable patients to measure certain health indicators, like blood pressure and body weight, from the comfort of their own homes. This information can also be shared electronically with doctors and other healthcare providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are developing a home monitoring solution for patients with heart failure to support their care and recovery at home after a visit to the emergency department. We hope to show that this solution decreases revisits to the emergency department and increases quality of life for patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, pre-post study design.
| Arm | Type | Receives |
|---|---|---|
| Home Telemonitoring | Experimental | Device: Remote Patient MonitoringPatients 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 receives and reviews the data electronically and will follow-up with the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 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 |
|---|---|---|
| Remote Patient Monitoring | Device | Home Telemonitoring |
Primary outcome
Change in number of emergency department revisits 90 day pre and 90 days post enrollment.
Time frame: 90 days
Hospital administrative data and self-reported data will be reviewed to assess the number of emergency department visits 90 day pre and 90 days post enrollment.
Change in the number of hospitalizations
Time frame: 90 days
Hospital administrative data and self-report data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment.
Change in the length of stay (in days)
Time frame: 90 days
Hospital administrative data and self-report data will be reviewed to assess the length of stay (measured in days) 90 day pre and 90 days post enrollment.
Mortality rate
Time frame: 90 days
The number of patients who pass away during the 90 day follow-up period will be recorded.
8 secondary outcomes
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 quality of life (general) scores as assessed by the VR-12
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 of patient experience of care via surveys
Time frame: 90 days
Impact of patient experience of care via interviews
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
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 24 Mar 2020.
- Derived from this study: PubMed 27977002TEC4Home Healthcare Innovation Community. Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home). JMIR Res Protoc. 2016 Dec 18;5(4):e198. doi: 10.2196/resprot.5856.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring in people with Heart Failure, run by University of British Columbia.
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 12 inclusion and 12 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: finished, 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.
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?
Change in number of emergency department revisits 90 day pre and 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 NCT02821065, 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.