Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Falls calendar - number of falls per month for 12 months, self-recorded by participant
研究概览
简要总结
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
详细描述
This observational study aims to investigate the incidence and risk factors for falls in the first 12 months post hospital discharge in patients following an ICU admission. It also aims to determine factors at hospital discharge which may predict future falls risk at 12 months and examine the physical activity levels of ICU survivors. Furthermore, it also will investigate the relationship between falls, fear of falling and activity limitations and participation restriction. All adult patients in intensive care that have been mechanically ventilated for over 48 hours, and remain in the ICU at least 4 days will be considered for inclusion. The primary outcome measure is a 12 month falls diary which commences on hospital discharge. There will also be Physiotherapy assessments just prior to hospital discharge, 3, 6, and 12 months post hospital discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalised adults aged 18 years
- •with an ICU admission requiring invasive mechanical ventilation for at least 48 hours and remain in ICU > 4 days
排除标准
- •Insufficient English language skills to read and understand questionnaires and patient information consent form
- •Pre-existing documented cognitive impairment
- •Spinal cord injury or other primary neuromuscular disease or new brain injury
- •Patient unable to be followed up due to geographic location
- •New lower limb fracture on this admission
- •Liver failure with abdominal distension due to ascites requiring fortnightly drainage
- •Recent history of stroke or major surgery affecting lower limb e.g. Total knee or hip replacement in the past 12 weeks
- •Neurological disorders such as Parkinson disease or multiple sclerosis
- •Poor premorbid function defined as <10 metres ambulation +/- gait aid independently
- •Frequent falls history defined as 3 or more falls over 2 months
- •incarcerated or safety concerns for follow up
- •discharged to palliative hospice facility
- •not expected to survive to 3 months post hospital discharge
- •unable to provide informed consent before hospital discharge due to current cognitive state (e.g. delirium, psychosis)
结局指标
主要结局
Falls calendar - number of falls per month for 12 months, self-recorded by participant
时间窗: One per month for 12 months
12-monthly falls calendar - This will record time to first fall, falls, incidence, number of falls including injurious falls.
次要结局
- Muscle ultrasound imaging(Baseline, 3, 6, and 12 months post discharge)
- Hand held dynamometry(Baseline, 3, 6, and 12 months post discharge)
- 4 metre walk test(Baseline, 3, 6, and 12 months post discharge)
- Falls Risk for Older People in the Community Setting (FROP-com) Questionairre(3, 6, and 12 months post discharge)
- MYMOP2 (in subgroup)(3, 6, and 12 months)
- Return to work(3, 6 and 12 months)
- mini-BEST(Baseline, 3, 6, and 12 months post discharge)
- MoCA(Baseline, 3, 6, and 12 months post discharge)
- Physical activity levels(Baseline, 3, 6, and 12 months post discharge)
- Clinical frailty scale questionairre(Baseline, 3, 6, and 12 months post discharge)
- Impact of Event Scale questionnaire (version: IES-R)(Baseline, 3, 6, and 12 months post discharge)
- Short Physical Performance Battery(Baseline, 3, 6, and 12 months post discharge)
- Hospital Anxiety and Depression Scale (HADS) Questionairre(Baseline, 3, 6, and 12 months post discharge)
- Fall efficacy scale questionnaire (version: FES-International short form)(Baseline, 3, 6, and 12 months post discharge)
- Healthcare usage(3, 6, and 12 months post discharge)
- EuroQol five dimensions questionnaire (version: EQ-5D-5L)(Baseline, 3, 6, and 12 months post discharge)
- FACIT Fatigue Scale (in subgroup)(3, 6 and 12 months)
- Sedentary behaviour questionnaire (in subgroup)(3, 6, and 12 months)
- Conor Davidson Resilience Questionnaire (in subgroup)(3, 6, and 12 months)
- Life Orientation Revised Optimism Scale (in subgroup)(3, 6, and 12 months)
- Pittsburgh Sleep Quality Index (in subgroup)(3, 6, and 12 months)
- Memorial symptoms questionnaire short form(3, 6, and 12 months)
研究者
Selina M Parry
Chief Investigator
University of Melbourne