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

NCT03439384 | Unknown

• 1 other identifier: H17-02846
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• Change in the number of emergency department visits 90 days pre to 90 days post enrollment.

  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.

  90 days

• Change in the number of hospitalizations 90 days pre to 90 days post enrollment.

  Hospital administrative data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment and between study groups.

  90 days

• Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment.

  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.

  90 days

• Mortality rate

  Administrative will be reviewed to determine the number of participants who passed away between study groups.

  90 days

Secondary Outcomes (6)

• 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

Study Arms (2)

Experimental: Home Telemonitoring

EXPERIMENTAL

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.

Device: Home Telemonitoring

Control: No Home Telemonitoring

NO INTERVENTION

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.

Interventions

Home Telemonitoring DEVICE

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 will be receiving the data electronically and reviewing on a daily basis.

Experimental: Home Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC

Vancouver, British Columbia, V5z 1M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 34081015 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kendall Ho, MD FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead, Digital Emergency Medicine; Professor, Department of Emergency Medicine, Faculty of Medicine, UBC

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 20, 2018
• Study Start: August 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

CA (1)