Back to resultsTelehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring (TEC4Home)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote Patient Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home Telemonitoring
Arm 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 receives and reviews the data electronically and will follow-up with the patient.
Outcomes
Primary Outcome Measures
Change in number of emergency department revisits 90 day pre and 90 days post enrollment.
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.
Change in the number of hospitalizations
Hospital administrative data and self-report data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment.
Change in the length of stay (in 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.
Mortality rate
The number of patients who pass away during the 90 day follow-up period will be recorded.
Secondary Outcome Measures
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.
Difference in quality of life (general) scores as assessed by the VR-12
A generic health-related quality of life questionnaire to be administered to all participants for comparison pre to post enrollment.
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.
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
Impact of patient experience of care via surveys
Feedback from patients via survey questions to understand their experiences using the home health monitoring technology.
Impact of patient experience of care via interviews
Feedback from patients via interview questions to understand their experiences using the home health monitoring technology.
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
NCT02821065
First Posted
May 24, 2016
Last Updated
March 20, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02821065
Brief Title
Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
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
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
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
Data Monitoring Committee
No
5. Study Description
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.
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
Single Group Assignment
Model Description
Single arm, pre-post study design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Telemonitoring
Arm Type
Experimental
Arm 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 receives and reviews the data electronically and will follow-up with the patient.
Intervention Type
Device
Intervention Name(s)
Remote Patient Monitoring
Primary Outcome Measure Information:
Title
Change in number of emergency department revisits 90 day pre and 90 days post enrollment.
Description
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.
Time Frame
90 days
Title
Change in the number of hospitalizations
Description
Hospital administrative data and self-report data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment.
Time Frame
90 days
Title
Change in the length of stay (in days)
Description
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.
Time Frame
90 days
Title
Mortality rate
Description
The number of patients who pass away during the 90 day follow-up period will be recorded.
Time Frame
90 days
Secondary Outcome Measure Information:
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.
Time Frame
90 days
Title
Difference in quality of life (general) scores as assessed by the VR-12
Description
A generic health-related quality of life questionnaire to be administered to all participants for comparison pre to post enrollment.
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.
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
Time Frame
90 days
Title
Impact of patient experience of care via surveys
Description
Feedback from patients via survey questions to understand their experiences using the home health monitoring technology.
Time Frame
90 days
Title
Impact of patient experience of care via interviews
Description
Feedback from patients via interview questions to understand their experiences using the home health monitoring technology.
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:
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
27977002
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.
Results Reference
derived
Learn more about this trial
Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
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