The TARGET-EFT Randomized Clinical Trial

Quality of Life Clinical Trial

— TARGET-EFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291690
• Other study ID #: TARGET-EFT 2020-2077
• Status: Completed
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: September 24, 2021

Study information

• Verified date: March 2022
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Diseases in Old Age
• Frailty
• Geriatric Cardiology
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jonathan Afilalo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frailty	Frailty will be assessed using the Essential Frailty Toolset (EFT) scale during hospital stay. Each item is scored from 0-2 points, yielding a total score of points 0-5.	Date of randomization to hospital discharge (assessed up to 6-weeks)
Other	Frailty	Sarcopenia will be assessed with the SARC-F scale at 30 days post-hospital discharge. Each item is scored 0-2 (0 = none, 2 = a lot or unable), yielding a total score of 0-10.	From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
Other	Mobility	Mobility during hospital stay will be measured using the Level of Function (LOF) scale. LOF is scored level 0-5 (0 = not responsive, not able to cooperate in care and is bed-bound, 5 = able to tolerate increased distances in walking around the unit).	Date of randomization to hospital discharge (assessed up to 6-weeks)
Other	Change in skeletal muscle mass	Skeletal muscle mass will be measured using a portable bioimpedance and/or ultrasound devices at baseline and discharge.	Date of randomization to hospital discharge (assessed up to 6-weeks)
Other	Step counts	Physical activity will be measured during the hospital stay. Average number of steps per day are recorded by actigraphy.	Date of randomization to hospital discharge (assessed up to 6-weeks)
Other	Anxiety and depression	Self-reported hospital anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS) at discharge. Items scored 0-3 (0 = no sign of anxiety/depression, 3 = signs of extreme anxiety/depression), yielding a total score of 0-21 for anxiety and depression.	Hospital discharge (assessed up to 6-weeks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)