The TARGET-EFT Trial (MulTicomponent Acute Intervention in FRail GEriatric PaTients With Cardiovascular Disease Using the Essential Frailty Toolset)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change in health-related quality of life: EQ-5D-5L scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •Frail or pre-frail as defined by EFT score ≥1
- •Admission to the JGH cardiovascular unit
- •Signed informed consent
排除标准
- •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
结局指标
主要结局
Change in health-related quality of life: EQ-5D-5L scale
时间窗: 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.
次要结局
- 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, 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)
- Length of stay(Date of cardiovascular unit admission to hospital discharge (assessed up to 6-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))
- 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))
- Time out of bed(Date of randomization to hospital discharge (assessed up to 6-weeks))
- Lower extremity physical performance(Date of randomization to hospital discharge (assessed up to 6-weeks))
研究者
Jonathan Afilalo
Director, Geriatric Cardiology Fellowship Program, Division of Cardiology and Centre for Clinical Epidemiology, Jewish General Hospital, McGill University
Jewish General Hospital