The TARGET-EFT Trial (MulTicomponent Acute Intervention in FRail GEriatric PaTients With Cardiovascular Disease Using the Essential Frailty Toolset)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- Jonathan Afilalo
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Change in health-related quality of life: EQ-5D-5L scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jonathan Afilalo
Director, Geriatric Cardiology Fellowship Program, Division of Cardiology and Centre for Clinical Epidemiology, Jewish General Hospital, McGill University
Jewish General Hospital
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
Outcomes
Primary Outcomes
Change in health-related quality of life: EQ-5D-5L scale
Time Frame: Date of randomization to hospital discharge (assessed up to 6-weeks)
Self-reported health-related quality of life is measured with EQ-5D at baseline and discharge. Items are scored level 1-5 (1 = no problems, 5 = unable/extreme problems). The visual analog scale is scored 0-100 (0 = worse imaginable health ever, 100 = best imaginable health ever). The scale generates a descriptive set that is compared to value sets to produce a value index.
Secondary Outcomes
- Change in Hospital-Acquired disability(Date of randomization to hospital discharge (assessed up to 6-weeks))
- Hospital-acquired disability(From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks))
- Number of participants with all-cause death, discharge to healthcare facility, unplanned repeat hospital visit(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)
- Length of stay(Date of cardiovascular unit admission to hospital discharge (assessed up to 6-weeks))
- Number of participants with all-cause death, delirium, fall, infection, pressure ulcer(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))
- Change in health-related quality of life: EQ-5D-5L scale(From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks))
- Time out of bed(Date of randomization to hospital discharge (assessed up to 6-weeks))
- Lower extremity physical performance(Date of randomization to hospital discharge (assessed up to 6-weeks))