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Clinical Trials/NCT03439384
NCT03439384
Unknown
Not Applicable

TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring

University of British Columbia1 site in 1 country390 target enrollmentAugust 1, 2018
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of British Columbia
Enrollment
390
Locations
1
Primary Endpoint
Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kendall Ho

Lead, Digital Emergency Medicine; Professor, Department of Emergency Medicine, Faculty of Medicine, UBC

University of British Columbia

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D).(90 days)
  • Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale.(90 days)
  • Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale.(90 days)
  • Difference in costs and savings via administrative data and a self-report healthcare utilization survey.(90 days)
  • Impact on communication between healthcare providers and patients via surveys.(90 days)
  • Impact on communication between healthcare providers and patients via interviews.(90 days)

Study Sites (1)

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