The TARGET-EFT Randomized Clinical Trial

NCT04291690 | Completed DMC

• 1 other identifier: TARGET-EFT 2020-2077
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Randomized Clinical Trial; Frailty; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

• 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, 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)

• 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

Other Outcomes (6)

• Frailty

  Date of randomization to hospital discharge (assessed up to 6-weeks)

• Frailty

  From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)

• Mobility

  Date of randomization to hospital discharge (assessed up to 6-weeks)

Study Arms (2)

Control Group

NO INTERVENTION

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

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

Interventions

Physical Component of the Intervention OTHER

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.

Intervention Group

Cognitive Component of the Intervention OTHER

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.

Intervention Group

Nutritional Component of the Intervention OTHER

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.

Intervention Group

Iron-Deficiency Anemia (IDA) Component of the Intervention OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years
• Frail or pre-frail as defined by EFT score ≥1
• Admission to the JGH cardiovascular unit
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonathan Afilalo: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Related Publications (1)

• Fountotos R, Ahmad F, Bharaj N, Munir H, Marsala J, Rudski LG, Goldfarb M, Afilalo J. Multicomponent intervention for frail and pre-frail older adults with acute cardiovascular conditions: The TARGET-EFT randomized clinical trial. J Am Geriatr Soc. 2023 May;71(5):1406-1415. doi: 10.1111/jgs.18228. Epub 2023 Jan 16.

  PMID: 36645227 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Afilalo, MD, MSc

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the allocated group of the patients, and they will not be the same team members that delivered the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Geriatric Cardiology Fellowship Program, Division of Cardiology and Centre for Clinical Epidemiology, Jewish General Hospital, McGill University

Model Details: Single-center randomized clinical trial with parallel group design at the Jewish General Hospital (JGH); an academic tertiary care center in Montreal, Quebec, Canada.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: March 2, 2020
• Study Start: March 5, 2020
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CA (1)