Back to resultsTEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care (TEC4Home)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home Telemonitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility 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.
Sites / Locations
- UBC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: Home Telemonitoring
Control: No Home Telemonitoring
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
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.
Change in the number of hospitalizations 90 days pre to 90 days post enrollment.
Hospital administrative data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment and between study groups.
Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment.
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.
Mortality rate
Administrative will be reviewed to determine the number of participants who passed away between study groups.
Secondary Outcome Measures
Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D).
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.
Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale.
A 12 item disease-specific quality of life questionnaire will be administered to all participants for comparison pre-post enrollment and between study groups.
Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale.
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.
Difference in costs and savings via administrative data and a self-report healthcare utilization survey.
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.
Impact on communication between healthcare providers and patients via surveys.
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.
Impact on communication between healthcare providers and patients via interviews.
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.
Full Information
NCT ID
NCT03439384
First Posted
January 16, 2018
Last Updated
March 20, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03439384
Brief Title
TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care
Acronym
TEC4Home
Official Title
TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Home Telemonitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: No Home Telemonitoring
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Home Telemonitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
Description
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.
Time Frame
90 days
Title
Change in the number of hospitalizations 90 days pre to 90 days post enrollment.
Description
Hospital administrative data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment and between study groups.
Time Frame
90 days
Title
Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment.
Description
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.
Time Frame
90 days
Title
Mortality rate
Description
Administrative will be reviewed to determine the number of participants who passed away between study groups.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D).
Description
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.
Time Frame
90 days
Title
Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale.
Description
A 12 item disease-specific quality of life questionnaire will be administered to all participants for comparison pre-post enrollment and between study groups.
Time Frame
90 days
Title
Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale.
Description
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.
Time Frame
90 days
Title
Difference in costs and savings via administrative data and a self-report healthcare utilization survey.
Description
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.
Time Frame
90 days
Title
Impact on communication between healthcare providers and patients via surveys.
Description
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.
Time Frame
90 days
Title
Impact on communication between healthcare providers and patients via interviews.
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendall Ho, MD FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5z 1M9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34081015
Citation
Ho K, Novak Lauscher H, Cordeiro J, Hawkins N, Scheuermeyer F, Mitton C, Wong H, McGavin C, Ross D, Apantaku G, Karim ME, Bhullar A, Abu-Laban R, Nixon S, Smith T. Testing the Feasibility of Sensor-Based Home Health Monitoring (TEC4Home) to Support the Convalescence of Patients With Heart Failure: Pre-Post Study. JMIR Form Res. 2021 Jun 3;5(6):e24509. doi: 10.2196/24509.
Results Reference
derived
Learn more about this trial
TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care
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