Clinical trial NCT03439384: TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care
Official title: TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
timeFrame: 90 days
measure: Change in the number of hospitalizations 90 days pre to 90 days post enrollment.
timeFrame: 90 days
measure: Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment.
timeFrame: 90 days
measure: Mortality rate
timeFrame: 90 days
Secondary outcomes:
measure: Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D).
timeFrame: 90 days
measure: Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale.
timeFrame: 90 days
measure: Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale.
timeFrame: 90 days
measure: Difference in costs and savings via administrative data and a self-report healthcare utilization survey.
timeFrame: 90 days
measure: Impact on communication between healthcare providers and patients via surveys.
timeFrame: 90 days
measure: Impact on communication between healthcare providers and patients via interviews.
timeFrame: 90 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kendall Ho, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.