TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care

University of British Columbia

Status: Unknown

Conditions: Heart Failure

Treatments: Device: Home Telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03439384

H17-02846

Details and patient eligibility

About

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.

Enrollment: 390 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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390 participants in 2 patient groups

Experimental: Home Telemonitoring

Experimental group

Description:

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.

Treatment:

Device: Home Telemonitoring

Control: No Home Telemonitoring

No Intervention group

Description:

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.