The TARGET-EFT Randomized 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.

Conditions

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

Interventions

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• Jonathan Afilalo

  lead OTHER

Principal Investigators

• Jonathan Afilalo, MD, MSc · Jewish General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-05

Primary Completion

2021-09-24

Completion

2021-09-24

Countries

• Canada

Study Locations