The TARGET-EFT Randomized Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The TARGET-EFT Trial (MulTicomponent Acute Intervention in FRail GEriatric PaTients With Cardiovascular Disease Using the Essential Frailty Toolset)

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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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. | |
| Experimental: Intervention Group<br>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. | Other: Physical Component of the Intervention<br>* We will encourage and assist patients to walk around the ward as tolerated and approved by their treating clinicians, to maximize the time spent out of bed, minimize the time spent in bed, and to encourage and assist them to perform chair rises to build lower extremity strength. For selected intervention patients with greater physical weakness, defined as SPPB ≤9, a Certified Exercise Physiologist will administer a supervised multicomponent exercise program combining strength, flexibility, balance and gait for the prevention of weakness and falls. The exercise program is adapted from the Vivifrail program which is an EU-funded initiative that provides a guide to prevent frailty, physical deconditioning, and incident disability in older persons. The program includes two daily sessions, one in the morning and one in the afternoon, for a duration of 20 minutes each. The morning session includes strength and flexibility exercises. The afternoon session targets balance and walking.<br>Other: Cognitive Component of the Intervention<br>* We will encourage and assist them to wear their hearing and visual aids (if they have these), orient them to time and place verbally and in writing on a clearly visible white-board in their hospital room - and also encourage their family members and caregivers to do so on a regular basis, and inquire about their sleep quality and communicate with the clinical team to reduce sleep disturbances. For selected intervention patients with greater cognitive impairments, defined as MMSE ≤26, we will provide cognitive simulation twice daily during the scheduled visits. Cognitive stimulation comprises of activities with the patient, including but not limited to current news, trivia, crossword puzzles, and memory games. These cognitive interventions are adapted from the Hospital Elder Life Program (HELP) that targets risk factors for delirium.<br>Other: Nutritional Component of the Intervention<br>* We will reinforce proper eating habits, encourage and assist patients to wear their dentures (if they have these), and inquire about their food preferences and eating barriers and communicate with the clinical dieticians to address these issues. For selected intervention patients with greater nutritional deficits, defined as a positive PONS, we will recommend to the treating clinicians to prescribe MedPass supplementation. PONS, developed as a preoperative screening tool but also used in nonoperative medical settings, reflects low body mass index, weight loss, low dietary intake, and albumin level. MedPass is a 60 mL calorically dense (2 kcal/mL) oral nutritional supplement consumed between meals 4 times per daily. If MedPass supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative supplementation strategies.<br>Other: Iron-Deficiency Anemia (IDA) Component of the Intervention<br>* We will verify their clinical blood test results for hemoglobin level and iron studies and apply the diagnostic criteria for iron deficiency as recommended by the Canadian Cardiovascular Society Guidelines for Heart Failure. These criteria are: (i) Hemoglobin <130g/L in men or <120g/L in women with (ii) a Ferritin <100μg/L or a Ferritin <300μg/L with a Saturation <20%. For selected intervention patients with diagnosed iron deficiency anemia, according to these established criteria, we will recommend to the treating clinicians to prescribe Venofer intravenous iron replacement therapy. The use of intravenous iron replacement therapy is a Strong Recommendation in the Canadian Cardiovascular Society Guidelines. Venofer is prescribed at a dosage of 300 mg IV daily for a total of 3 doses. If Venofer supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative strategies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life: EQ-5D-5L scale | 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. | Date of randomization to hospital discharge (assessed up to 6-weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life: EQ-5D-5L scale | 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. | From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks) | 
| Change in Hospital-Acquired disability | 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. | Date of randomization to hospital discharge (assessed up to 6-weeks) | 
| Hospital-acquired disability | 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. | 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, delirium, fall, infection, pressure ulcer | Composite endpoint | 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) | 
| Number of participants with all-cause death, discharge to healthcare facility, unplanned repeat hospital visit | Composite endpoint | 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 | Number of days from cardiovascular unit admission to hospital discharge. | Date of cardiovascular unit admission to hospital discharge (assessed up to 6-weeks) | 
| Time out of bed | Average number of hours per day out of bed recorded by actigraphy | Date of randomization to hospital discharge (assessed up to 6-weeks) | 
| Lower extremity physical performance | 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). | Date of randomization to hospital discharge (assessed up to 6-weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Clinical Trial, Frailty, Intervention