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

NCT ID: NCT02821065

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Home Telemonitoring

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.

Group Type: EXPERIMENTAL

Remote Patient Monitoring

Intervention Type: DEVICE

Interventions

Remote Patient Monitoring

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kendall Ho

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27977002 (View on PubMed)

Other Identifiers

H16-01076

Identifier Type: -

Identifier Source: org_study_id