Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1): Training and Provision of Walking Aids to Promote Autonomy and Mobility of Elderly People in Emergency Care - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Life-Space Assessment (LSA)
研究概览
简要总结
Older adults have higher rates of emergency department admissions when compared to their younger counterparts. Mobility is the ability to move around but also encompasses the environment and the ability to adapt to it. Walking aids can be used to improve mobility and prevent falls. According to international guidelines, they must be available in Geriatric Emergency Department. This study aims to evaluate the effectiveness of a program of training and provision of walking aids (WA), associated or not with telemonitoring, on mobility, quality of life, fear of falling, and risk of falls up to 3 months in older adults cared for in an emergency department.
详细描述
A randomized clinical trial will be carried out in the emergency department of Hospital Sírio-Libanês. Participants will be randomized and allocated into three intervention groups, as follows: A) Walking aid group; B) Walking aid and telemonitoring group; C) Control group. Patients will undergo a baseline evaluation encompassing sociodemographic and clinical data, mobility in life spaces (Life Space Assessment), gait speed, muscle strength, functionality (Barthel Index, Katz index, and Lawton-Brody Scale), quality of life (Euro Quality of Life Instrument-5D), fear of falling (Falls Efficacy Scale International), history of falls, cognition (10-Point Cognitive Screener) and mood (15-point Geriatric Depression Scale) before the intervention. Gait time and fear of falling will be assessed again after the intervention. Finally, mobility in life spaces, functionality, quality of life, fear of falling, history of falls, cognition, and mood will be assessed 3 months after discharge from the geriatric emergency department through a telephone interview.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
This study will be blind for the researchers involved in the post-telemonitoring assessments. Also, the data will be analyzed by a researcher who is not involved in the interventions or the assessments.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years or older
- •Admitted to the Geriatric Emergency Department of Hospital Sírio-Libanês
- •Willing and able to give informed consent
- •Least one of the following for indication and training of mobility aids: reduction of postural instability; improvement of motor control; increase of somatosensory feedback; reduction of biomechanical overload; safe promotion of autonomy; fall history (in the last six months).
排除标准
- •Altered level of conscience
- •need for supplemental oxygen (≥3L/min)
- •respiratory distress
- •hemodynamic instability
- •postural instability with a tendency to fall backward
- •cognitive impairment that limits the use of walking aids
- •hospitalization after Emergency Department evaluation
研究组 & 干预措施
Control group
Participants will receive verbal guidance and printed material.
干预措施: Guidance on safe walking and risk of falling (Other)
Walking aid (WA) group
Participants will receive the walking aid and training in the use of the device.
干预措施: Walking aid (Device)
Walking aid (WA) group
Participants will receive the walking aid and training in the use of the device.
干预措施: Guidance on safe walking and risk of falling (Other)
Walking aid with telemonitoring (WAT) group
Participants will receive the walking aid and training in the use of the device associated with telemonitoring.
干预措施: Walking aid (Device)
Walking aid with telemonitoring (WAT) group
Participants will receive the walking aid and training in the use of the device associated with telemonitoring.
干预措施: Telemonitoring (Other)
Walking aid with telemonitoring (WAT) group
Participants will receive the walking aid and training in the use of the device associated with telemonitoring.
干预措施: Guidance on safe walking and risk of falling (Other)
结局指标
主要结局
Life-Space Assessment (LSA)
时间窗: At baseline and after completion of the 3 and 6 months intervention to assess change
LSA is a scale which allows the characterization of mobility in life-spaces specifically frequency, need for mobility aids and the help of third party in the last 4 weeks
Falls Efficacy Scale International (FES-I)
时间窗: At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change
Assesses fear of falling
次要结局
- Geriatric Depression Scale (GDS-15)(At baseline and after completion of the 3 and 6 months intervention to assess change)
- 10-Point Cognitive Screener (10-CS)(At baseline and after completion of the 3 and 6 months intervention to assess change)
- Fall History(At baseline and after completion of the 3 and 6 months intervention to assess change)
- Timed Up and Go test (TUG)(At baseline and immediately after the intervention)
- Katz index(At baseline and after completion of the 3 and 6 months intervention to assess change)
- Lawton-Brody scale(At baseline and after completion of the 3 and 6 months intervention to assess change)
- Euro Quality of Life Instrument-5D (EQ-5D)(At baseline and after completion of the 3 and 6 months intervention to assess change)
- One-minute sit-to-stand test(At baseline and after completion of the 3 and 6 months intervention to assess change)
- Barthel index(At baseline and after completion of the 3 and 6 months intervention to assess change)