Telehealth Home-monitoring for Frailty in Cardiac Surgery

NCT05349708 | Completed

• 1 other identifier: 100097
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Surgery; Cardiac Event

Keywords

technology; outcomes; hospital readmission; feasibility; follow-up; remote care

Outcome Measures

Primary Outcomes (1)

• 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

  30 days of discharge post-cardiac surgery

Secondary Outcomes (3)

• Length of hospital stay (LOS, days) and discharge disposition

  Duration of stay at the hospital post-cardiac surgery

• Rate of readmission to hospital and/or ER visit and reasons

  30 days of discharge post-cardiac surgery

• Percentage of patients who faced difficulties with the Telehealth intervention and causes of the same

  30 days of discharge post-cardiac surgery

Study Arms (2)

Participant

EXPERIMENTAL

Patients who were sent home with the intervention post-surgery

Device: THE-FACS

Historical controls

NO INTERVENTION

Interventions

THE-FACS DEVICE

Telehealth home-monitoring tablet and blood pressure cuff

Participant

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Brunswick Heart Centre: lead

Study Sites (1)

New Brunswick Heart Centre, Saint John Regional Hospital

Saint John, New Brunswick, E2L4L4, Canada

Location

MeSH Terms

Conditions

Frailty; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-François Légaré, M.D., Ph.D.

  New Brunswick Heart Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Head of Cardiac Surgery

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 27, 2022
• Study Start: October 30, 2019
• Primary Completion: March 18, 2020
• Study Completion: December 31, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)