Clinical trial NCT04291690: The TARGET-EFT Randomized Clinical Trial
Official title: The TARGET-EFT Trial (MulTicomponent Acute Intervention in FRail GEriatric PaTients With Cardiovascular Disease Using the Essential Frailty Toolset)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Cardiovascular Diseases in Old Age
Geriatric Cardiology
Quality of Life
Keywords: Randomized Clinical Trial
Frailty
Intervention
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center randomized clinical trial with parallel group design at the Jewish General Hospital (JGH); an academic tertiary care center in Montreal, Quebec, Canada.
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to determine whether a multicomponent intervention will lead to improvements in mobility, self-care, mood, pain, and physical activity among frail and pre-frail older adults (as measured with the Essential Frailty Toolset; EFT) hospitalized for an acute cardiovascular illness.

Detailed description: The investigators will conduct a single-center randomized clinical trial at the Jewish General Hospital; an academic tertiary care center in Montreal, Quebec. Researchers will pre-screen stable patients ≥65 years of age admitted to the cardiovascular unit. The investigators will target those that consent and have evidence of frailty or pre-frailty according to the EFT (score ≥1/5). The EFT consists of a chair rise test to screen for physical frailty, a mini-cog test to screen for cognitive impairment, a hemoglobin level and a serum albumin level. Patients will be randomly allocated to the usual-care control group, or the intervention group that will receive targeted treatments depending on the EFT deficits identified. All patients will be outfitted with a hip-worn accelerometer to monitor position, step count, and sleep data during the study period. Patients will undergo a structured questionnaire and physical performance assessment at baseline (upon index admission) and at discharge, and will be contacted by telephone 30 days post-discharge to assess their recovery. The primary endpoint will be represented by the EQ-5D scale (mobility, self-care, mood, pain, and physical activity) measured by blinded observers.

Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Frail or pre-frail as defined by EFT score ≥1
* Admission to the JGH cardiovascular unit
* Signed informed consent

Exclusion Criteria:

* Expected discharge within \<3 days
* Clinically unstable (unstable vital signs, low-threshold coronary ischemia, uncontrolled heart failure, uncontrolled arrhythmia)
* Awaiting cardiac surgery during the index hospitalization
* Severe dementia (MMSE ≤10/30)
* Delirium (CAM positive)
* Psychiatric condition precluding cooperation
* Not English or French speaking
* Parkinson's disease
* Recent stroke \<7 days
* Bed-bound or paraplegic
* End-of-life care plan

Primary outcomes:
measure: Change in health-related quality of life: EQ-5D-5L scale
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
Secondary outcomes:
measure: Change in health-related quality of life: EQ-5D-5L scale
timeFrame: From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
measure: Change in Hospital-Acquired disability
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
measure: Hospital-acquired disability
timeFrame: From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
measure: Number of participants with all-cause death, delirium, fall, infection, pressure ulcer
timeFrame: Date of randomization until date of first documented progression of all-cause death, delirium, fall, infection, pressure ulcer assessed up to hospital discharge (assessed up to 6-weeks)
measure: Number of participants with all-cause death, discharge to healthcare facility, unplanned repeat hospital visit
timeFrame: Date of hospital discharge (assessed up to 6-weeks) until date of first documented progression of all-cause death, discharge to healthcare facility, unplanned repeat hospital visit assessed up to 30-days from hospital discharge
measure: Length of stay
timeFrame: Date of cardiovascular unit admission to hospital discharge (assessed up to 6-weeks)
measure: Time out of bed
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
measure: Lower extremity physical performance
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
Other outcomes:
measure: Frailty
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
measure: Frailty
timeFrame: From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
measure: Mobility
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
measure: Change in skeletal muscle mass
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
measure: Step counts
timeFrame: Date of randomization to hospital discharge (assessed up to 6-weeks)
measure: Anxiety and depression
timeFrame: Hospital discharge (assessed up to 6-weeks)
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Jonathan Afilalo, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: