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Telehealth Home-monitoring for Frailty in Cardiac Surgery (THE-FACS)

Primary Purpose

Frailty, Surgery, Cardiac Event

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
THE-FACS
Sponsored by
New Brunswick Heart Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty focused on measuring technology, outcomes, hospital readmission, feasibility, follow-up, remote care

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients, aged 55 years or older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement, mitral valve repair/replacement or combined CABG/valve procedures.
  2. Patients defined as pre- vulnerable, vulnerable or frail based on the Edmonton frailty scale (> 4 considered pre- vulnerable) as defined prior to surgery

Exclusion Criteria:

  1. Medical reasons for exclusion

    1. Patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery
    2. Acute endocarditis who are at higher risk for adverse events
  2. Dialysis dependent who are at higher risk for adverse events
  3. Patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention
  4. Patients who do not have any support or potential caregivers to help facilitate their transition home
  5. Patients undergoing minimally invasive surgery which has been shown to enhance recovery
  6. Patients unable to be discharged home within 10 days of their surgery. The average length of hospitalization is 5 days with frail patients often requiring additional time but usually within 10 days unless some major barrier exists in allowing discharge home.
  7. Patients who are transferred to another hospital for recovery or care.

Sites / Locations

  • New Brunswick Heart Centre, Saint John Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Participant

Historical controls

Arm Description

Patients who were sent home with the intervention post-surgery

Outcomes

Primary Outcome Measures

Rates of emergency room visit and readmission to hospital
The aim was to compare the rate of emergency room visits and readmission to hospital within 30 days of discharge between two groups of patients: frail, post-surgery cardiac surgery patients who went home with the intervention for self-monitoring of health versus historical controls

Secondary Outcome Measures

Length of hospital stay (LOS, days) and discharge disposition
The post-surgery inclusion criterion was the LOS of 10 days or less and home-discharge. The investigators, therefore, assessed the LOS and discharge disposition of the frail participants who consented to participate in the study to understand the challenges in recovery and ability to participate in the study.
Rate of readmission to hospital and/or ER visit and reasons
The aim of the telehealth home monitoring platform was to reduce hospital readmission and/ or ER visits within 30 days of discharge post-cardiac surgery. The investigators, therefore, wanted to explore the rates and causes for the above-mentioned outcomes.
Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same
Identification of the major challenges frail participants faced in using a technology-based home monitoring program to self-monitor their health and recovery post-cardiac surgery. A participation-satisfaction questionnaire was used to assess the percentage of patients who could/ count not use the intervention and the reasons for such (technological challenges, connectivity ussies, etc.).

Full Information

First Posted
April 6, 2022
Last Updated
April 22, 2022
Sponsor
New Brunswick Heart Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05349708
Brief Title
Telehealth Home-monitoring for Frailty in Cardiac Surgery
Acronym
THE-FACS
Official Title
Benefit of a Telehealth Home-monitoring Program for Vulnerable Patients and Patients Living With Frailty Undergoing Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New Brunswick Heart Centre

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
Cardiac surgical interventions are increasingly offered to vulnerable patients or patients living with frailty. Unfortunately, frailty has been shown to be an independent predictor of poorer outcome and increased health care resources in terms of readmission to hospital or visit to the ER after discharge. We hypothesize that the use of a comprehensive Telehealth home-monitoring program could reduce emergency room visits and re-hospitalization after heart surgery. Frailty in all patients will be determined using the Edmonton frailty scale (EFS) as is part of the current standard of care for all patients at the NBHC since 2018. We plan to implement the Telehealth intervention on all 120 consecutively enrolled patients identified as vulnerable and/or frail and discharged from hospital within 10 days of their surgery. The primary outcome of interest will be rates of ER visit and readmission to hospital within 30 days of discharge compared to propensity score matched historical control patients. A power calculation suggests that 120 patients per group are necessary explaining why the intervention group will be 120 patients. We chose to compare our intervention to a matched group of 240 individuals from historical data which already captures follows patients 30 days after surgery but is limited in its Telehealth intervention. Duration of the study is 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Surgery, Cardiac Event
Keywords
technology, outcomes, hospital readmission, feasibility, follow-up, remote care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participant
Arm Type
Experimental
Arm Description
Patients who were sent home with the intervention post-surgery
Arm Title
Historical controls
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
THE-FACS
Intervention Description
Telehealth home-monitoring tablet and blood pressure cuff
Primary Outcome Measure Information:
Title
Rates of emergency room visit and readmission to hospital
Description
The aim was to compare the rate of emergency room visits and readmission to hospital within 30 days of discharge between two groups of patients: frail, post-surgery cardiac surgery patients who went home with the intervention for self-monitoring of health versus historical controls
Time Frame
30 days of discharge post-cardiac surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay (LOS, days) and discharge disposition
Description
The post-surgery inclusion criterion was the LOS of 10 days or less and home-discharge. The investigators, therefore, assessed the LOS and discharge disposition of the frail participants who consented to participate in the study to understand the challenges in recovery and ability to participate in the study.
Time Frame
Duration of stay at the hospital post-cardiac surgery
Title
Rate of readmission to hospital and/or ER visit and reasons
Description
The aim of the telehealth home monitoring platform was to reduce hospital readmission and/ or ER visits within 30 days of discharge post-cardiac surgery. The investigators, therefore, wanted to explore the rates and causes for the above-mentioned outcomes.
Time Frame
30 days of discharge post-cardiac surgery
Title
Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same
Description
Identification of the major challenges frail participants faced in using a technology-based home monitoring program to self-monitor their health and recovery post-cardiac surgery. A participation-satisfaction questionnaire was used to assess the percentage of patients who could/ count not use the intervention and the reasons for such (technological challenges, connectivity ussies, etc.).
Time Frame
30 days of discharge post-cardiac surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients, aged 55 years or older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement, mitral valve repair/replacement or combined CABG/valve procedures. Patients defined as pre- vulnerable, vulnerable or frail based on the Edmonton frailty scale (> 4 considered pre- vulnerable) as defined prior to surgery Exclusion Criteria: Medical reasons for exclusion Patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery Acute endocarditis who are at higher risk for adverse events Dialysis dependent who are at higher risk for adverse events Patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention Patients who do not have any support or potential caregivers to help facilitate their transition home Patients undergoing minimally invasive surgery which has been shown to enhance recovery Patients unable to be discharged home within 10 days of their surgery. The average length of hospitalization is 5 days with frail patients often requiring additional time but usually within 10 days unless some major barrier exists in allowing discharge home. Patients who are transferred to another hospital for recovery or care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François Légaré, M.D., Ph.D.
Organizational Affiliation
New Brunswick Heart Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Brunswick Heart Centre, Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L4L4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Telehealth Home-monitoring for Frailty in Cardiac Surgery

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