NCT05349708: THE-FACS

Telehealth Home-monitoring for Frailty in Cardiac Surgery

Completed NA Last updated 27 April 2022

What this trial tests

NA trial testing THE-FACS in Frailty in 64 participants. Completed in 31 December 2021.

Timeline

30 October 2019

Primary endpoint
18 March 2020

31 December 2021

Quick facts

Lead sponsor	New Brunswick Heart Centre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	64
Start date	30 October 2019
Primary completion	18 March 2020
Estimated completion	31 December 2021
Sites	1 location across Canada

Drugs / interventions tested

• THE-FACS

Conditions studied

• Frailty — all drugs for Frailty →
• Surgery — all drugs for Surgery →
• Cardiac Event — all drugs for Cardiac Event →

Sponsor

New Brunswick Heart Centre

Who can join

60 and older, any sex, with Frailty or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhanced Telehealth Home-Monitoring Intervention for Vulnerable and Frail Patients after Cardiac Surgery (THE-FACS Pilot Intervention Study).
   Sarkar S, MacLeod J, Hassan A, Brunt KR, et al · · 2022 · cited 10× · PMID 36333652 · DOI 10.1186/s12877-022-03531-4