The TARGET-EFT Randomized Clinical Trial

Jonathan Afilalo

Status: Completed

Conditions: Quality of Life; Cardiovascular Diseases in Old Age; Geriatric Cardiology; Frailty

Treatments: Other: Nutritional Component of the Intervention; Other: Iron-Deficiency Anemia (IDA) Component of the Intervention; Other: Physical Component of the Intervention; Other: Cognitive Component of the Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04291690

TARGET-EFT 2020-2077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Control Group

No Intervention group

Description:

Usual clinical care as prescribed by their treating clinicians; which may or may not include physiotherapy, geriatric consultation, nutritional consultation and supplementation, and treatment of anemia.

Intervention Group

Experimental group

Description:

Multi-component intervention in addition to usual care; which may include - in a targeted fashion - physical training for those with physical weakness, cognitive stimulation for those with cognitive impairment, oral nutritional supplementation for those with malnutrition, and intravenous iron replacement therapy for those with iron deficiency anemia.

Treatment:

Other: Physical Component of the Intervention

Other: Cognitive Component of the Intervention

Other: Nutritional Component of the Intervention

Other: Iron-Deficiency Anemia (IDA) Component of the Intervention