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

NCT02821065 | Completed

• 1 other identifier: H16-01076
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Modern technology like computers, smartphones and the Internet enable patients to measure certain health indicators, like blood pressure and body weight, from the comfort of their own homes. This information can also be shared electronically with doctors and other healthcare providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are developing a home monitoring solution for patients with heart failure to support their care and recovery at home after a visit to the emergency department. We hope to show that this solution decreases revisits to the emergency department and increases quality of life for patients.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• Change in number of emergency department revisits 90 day pre and 90 days post enrollment.

  Hospital administrative data and self-reported data will be reviewed to assess the number of emergency department visits 90 day pre and 90 days post enrollment.

  90 days

• Change in the number of hospitalizations

  Hospital administrative data and self-report data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment.

  90 days

• Change in the length of stay (in days)

  Hospital administrative data and self-report data will be reviewed to assess the length of stay (measured in days) 90 day pre and 90 days post enrollment.

  90 days

• Mortality rate

  The number of patients who pass away during the 90 day follow-up period will be recorded.

  90 days

Secondary Outcomes (8)

• Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale

  90 days

• Difference in quality of life (general) scores as assessed by the VR-12

  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 of patient experience of care via surveys

  90 days

Study Arms (1)

Home Telemonitoring

EXPERIMENTAL

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 receives and reviews the data electronically and will follow-up with the patient.

Device: Remote Patient Monitoring

Interventions

Remote Patient Monitoring DEVICE

Home Telemonitoring

Eligibility Criteria

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

You may qualify if:

• PATIENT PARTICIPANTS:
• 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.
• CLINICIAN PARTICIPANTS:
• To be eligible to participate, clinician participants (i.e. ED physicians, family physicians and monitoring nurse(s)) must have referred or have a patient enrolled in the TEC4Home monitoring service.

You may not qualify if:

• PATIENT PARTICIPANTS:
• 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.
• CLINICIAN PARTICIPANTS:
• Clinicians who do not have patients enrolled in the TEC4Home service or who themselves are not involved in the implementation or operation of the TEC4Home monitoring service will not be eligible to participate.

Sponsors & Collaborators

• University of British Columbia: lead

Related Publications (1)

• TEC4Home Healthcare Innovation Community. Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home). JMIR Res Protoc. 2016 Dec 18;5(4):e198. doi: 10.2196/resprot.5856.

  PMID: 27977002 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

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

Model Details: Single arm, pre-post study design.

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: July 1, 2016
• Study Start: October 31, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 24, 2020

Record last verified: 2020-03