Status:
UNKNOWN
TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care
Lead Sponsor:
University of British Columbia
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT03439384
Start Date
August 1 2018
End Date
December 31 2020
Last Update
March 24 2020
Active Locations (1)
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1
UBC
Vancouver, British Columbia, Canada, V5z 1M9