Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Iowa Oral Performance Instrument (IOPI) change
研究概览
简要总结
In Amyotrophic Lateral Sclerosis, dysphagia has a high incidence. With deterioration of swallowing function, percutaneous endoscopic gastrostomy (PEG) tube is recommended to ensure sufficient and safe oral intake. Dysphagia and PEG placement alter quality of life (QoL). However, QoL and attitudes toward PEG remain largely unexplored. The purpose of this study is to monitor the swallowing function in relationship to QoL and attitudes toward PEG tube insertion and feeding.
详细描述
The purpose of this study is to monitor the deterioration of swallowing function in ALS patient population, and to explore its impact on QoL and attitudes toward PEG tube insertion and feeding in the course of the disease. It will take maximum of 60 minutes to fully evaluate the swallowing function and complete the questionnaires. The evaluation procedure will be repeated every 3 months until PEG tube insertion, which will allow us to closely monitor the swallowing function in a relation to attitudes toward PEG and QoL. The data obtained from this study should contribute significantly to the knowledge of QoL in ALS patients with dysphagia, and it will allow for a comparison of QoL in ALS patients with and without PEG tube. This study will also expand the understanding of attitudes in ALS patients and their relatives toward PEG, and the impact of those attitudes on the decision-making process.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Iowa Oral Performance Instrument (IOPI) change
时间窗: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
IOPI is a device which measures tongue strength (in kilopascals; kPa) and endurance (in seconds) while the participant presses the bulb with the front or the base of their tongue to the hard palate.
Mann Assessment of Swallowing Ability (MASA) change
时间窗: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
MASA is a standard clinical swallowing assessment protocol administered by the speech-language therapist. Total score ranges from 38-200. Lower score indicates higher impairment.
Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change
时间窗: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
The questionnaire comprises 10 questions. The participants specify their level of agreement on a five-point Likert-type scale (1=strongly disagree, 5= strongly agree).
Yale Residue Severity Rating Scale (YRSRS) change
时间窗: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
YRSRS is a validated measure of swallowing efficiency using an image-based assessment to determine post-swallow pharyngeal residue: location and severity. It is assessed using a 5-point ordinal scale (from 1=0 % residue to 5=50 % residue).
Eating Assessment Tool 10 (EAT-10) change
时间窗: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
EAT-10 is a validated self-administered dysphagia severity symptom survey including 10 items and a five-point scale (0=no problem to 4=sever problem). Higher total score indicates higher impairment.
Swallowing Quality of Life Questionnaire (SWAL-QoL) change
时间窗: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion
SWAL-QoL is a 44-item standardised psychometric scale that measures swallowing-related QoL across 10 domains. Scores for each individual domain and a total SWAL-QoL score are calculated. Total score ranges from 0-100 (100 indicating the most favourable state).
Penetration-Aspiration Scale (PAS) change
时间窗: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
PAS is an 8-point scale used to determine swallowing safety. Levels 1 and 2 are considered safe, levels \>3 indicate penetration or aspiration and are considered unsafe.
次要结局
- Functional Oral Intake Scale (FOIS) change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))
- Dysphagia Outcome and Severity Scale (DOSS) change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))
- Maximal Inspiratory Pressure (MIP) change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))
- ALS Functional Rating Scale-Revised (ALSFRS-R) change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))
- BMI change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))
- Forced Vital Capacity (FVC) change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))
- Peak Cough Flow (PCF) change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))
- Maximal Expiratory Pressure (MEP) change(Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months))