The TARGET-EFT Randomized Clinical Trial
- Conditions
- FrailtyCardiovascular Diseases in Old AgeQuality of LifeGeriatric Cardiology
- Interventions
- Other: Physical Component of the InterventionOther: Cognitive Component of the InterventionOther: Nutritional Component of the InterventionOther: Iron-Deficiency Anemia (IDA) Component of the Intervention
- Registration Number
- NCT04291690
- Lead Sponsor
- Jonathan Afilalo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- Age ≥65 years
- Frail or pre-frail as defined by EFT score ≥1
- Admission to the JGH cardiovascular unit
- Signed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Cognitive Component of the Intervention 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. Intervention Group Physical Component of the Intervention 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. Intervention Group Nutritional Component of the Intervention 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. Intervention Group Iron-Deficiency Anemia (IDA) Component of the Intervention 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.
- Primary Outcome Measures
Name Time Method Change in health-related quality of life: EQ-5D-5L scale 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 Outcome Measures
Name Time Method Change in Hospital-Acquired disability Date of randomization to hospital discharge (assessed up to 6-weeks) Hospital-acquired disability will be measured using the Older Americans Resources and Services (OARS) Activities of Daily Living (ADL) Scale. ADLs will be assessed at baseline and discharge. Each item is scored 1-3 (1 = without help, 3 = completely unable to), yielding a total score of 0-7.
Hospital-acquired disability From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks) Hospital-acquired disability will be measured using the Older Americans Resources and Services (OARS) Activities of Daily Living (ADL) Scale. ADLs will be assessed at 30-days post-hospitalization. Each item is scored 1-3 (1 = without help, 3 = completely unable to), yielding a total score of 0-7.
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 Composite endpoint
Length of stay Date of cardiovascular unit admission to hospital discharge (assessed up to 6-weeks) Number of days from cardiovascular unit admission to hospital discharge.
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) Composite endpoint
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) Self-reported health-related quality of life is measured with EQ-5D at 30-days post-hospitalization. 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.
Time out of bed Date of randomization to hospital discharge (assessed up to 6-weeks) Average number of hours per day out of bed recorded by actigraphy
Lower extremity physical performance Date of randomization to hospital discharge (assessed up to 6-weeks) Lower extremity weakness will be assessed using the Short Physical Performance Battery scale (SPPB) at baseline and discharge. SPPB is scored 0-12 (0 = worst physical performance, 12 = best physical performance).
Trial Locations
- Locations (1)
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada