Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05349708
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2022-04-06
Brief Title:
Telehealth Home-monitoring for Frailty in Cardiac Surgery
Sponsor:
New Brunswick Heart Centre
Organization:
New Brunswick Heart Centre
Study Overview
Official Title:
Benefit of a Telehealth Home-monitoring Program for Vulnerable Patients and Patients Living With Frailty Undergoing Heart Surgery
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THE-FACS
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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None