Telehealth Home-monitoring for Frailty in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Frailty Surgery Cardiac Event

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Participant

Patients who were sent home with the intervention post-surgery

Group Type EXPERIMENTAL

THE-FACS

Intervention Type DEVICE

Telehealth home-monitoring tablet and blood pressure cuff

Historical controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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THE-FACS

Telehealth home-monitoring tablet and blood pressure cuff

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No