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Trial record 1 of 1 for:    NCT03439384
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TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care (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: NCT03439384
Recruitment Status : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kendall Ho, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Home Telemonitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
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 : August 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Experimental: Home Telemonitoring
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
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.

No Intervention: Control: No Home Telemonitoring
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.



Primary Outcome Measures :
  1. Change in the number of emergency department visits 90 days pre to 90 days post enrollment. [ Time Frame: 90 days ]
    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.

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

  3. Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment. [ Time Frame: 90 days ]
    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.

  4. Mortality rate [ Time Frame: 90 days ]
    Administrative will be reviewed to determine the number of participants who passed away between study groups.


Secondary Outcome Measures :
  1. Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D). [ Time Frame: 90 days ]
    A 5 item generic health-related quality of life questionnaire to be administered to all participants for comparison pre-post enrollment and between study groups.

  2. 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 and between study groups.

  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 and between study groups.

  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 and between study groups.

  5. 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.

  6. 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:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439384


Locations
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Canada, British Columbia
UBC
Vancouver, British Columbia, Canada, V5z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Kendall Ho, MD FRCPC University of British Columbia
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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: NCT03439384    
Other Study ID Numbers: H17-02846
First Posted: February 20, 2018    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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Heart Failure
Heart Diseases
Cardiovascular Diseases