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Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring (TEC4Home)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02821065
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kendall Ho, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Remote Patient Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, pre-post study design.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
Actual Study Start Date : October 31, 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: 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.
Device: Remote Patient Monitoring



Primary Outcome Measures :
  1. Change in number of emergency department revisits 90 day pre and 90 days post enrollment. [ Time Frame: 90 days ]
    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.

  2. Change in the number of hospitalizations [ Time Frame: 90 days ]
    Hospital administrative data and self-report data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment.

  3. Change in the length of stay (in days) [ Time Frame: 90 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.

  4. Mortality rate [ Time Frame: 90 days ]
    The number of patients who pass away during the 90 day follow-up period will be recorded.


Secondary Outcome Measures :
  1. Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale [ Time Frame: 90 days ]
    A 12 item disease-specific quality of life questionnaire will be administered to all participants for comparison pre-post enrollment.

  2. Difference in quality of life (general) scores as assessed by the VR-12 [ Time Frame: 90 Days ]
    A generic health-related quality of life questionnaire to be administered to all participants for comparison pre to post enrollment.

  3. Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale [ Time Frame: 90 Days ]
    A 9 item scale to asses a patient's self-care behaviours and attitudes specific to Heart Failure will be administered to all participants for comparison pre-post enrollment.

  4. Difference in costs and savings via administrative data and a self-report healthcare utilization survey. [ Time Frame: 90 days ]
    Costs related to healthcare utilization and other health-related out of pocket and system costs will be assessed and compared 90 days pre to 90 days post enrollment

  5. Impact of patient experience of care via surveys [ Time Frame: 90 days ]
    Feedback from patients via survey questions to understand their experiences using the home health monitoring technology.

  6. Impact of patient experience of care via interviews [ Time Frame: 90 days ]
    Feedback from patients via interview questions to understand their experiences using the home health monitoring technology.

  7. Impact on communication between healthcare providers and patients via surveys [ Time Frame: 90 days ]
    Surveys about end-user experience will be used to collect feedback from patient participants, nurses, and other healthcare providers involved to understand the impact of home health monitoring on communication during the transition of care.

  8. Impact on communication between healthcare providers and patients via interviews [ Time Frame: 90 days ]
    Interviews about end-user experience will be used to collect feedback from patient participants, nurses, and other healthcare providers involved to understand the impact of home health monitoring on communication during the transition of care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kendall Ho, Lead, Digital Emergency Medicine; Professor, Department of Emergency Medicine, Faculty of Medicine, UBC, University of British Columbia
ClinicalTrials.gov Identifier: NCT02821065    
Other Study ID Numbers: H16-01076
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes