Clinical trial NCT02821065: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
Official title: TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, pre-post study design.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in number of emergency department revisits 90 day pre and 90 days post enrollment.
timeFrame: 90 days
measure: Change in the number of hospitalizations
timeFrame: 90 days
measure: Change in the length of stay (in days)
timeFrame: 90 days
measure: Mortality rate
timeFrame: 90 days
Secondary outcomes:
measure: Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale
timeFrame: 90 days
measure: Difference in quality of life (general) scores as assessed by the VR-12
timeFrame: 90 Days
measure: Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale
timeFrame: 90 Days
measure: Difference in costs and savings via administrative data and a self-report healthcare utilization survey.
timeFrame: 90 days
measure: Impact of patient experience of care via surveys
timeFrame: 90 days
measure: Impact of patient experience of care via interviews
timeFrame: 90 days
measure: Impact on communication between healthcare providers and patients via surveys
timeFrame: 90 days
measure: Impact on communication between healthcare providers and patients via interviews
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
citation: 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.