Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Официальное название

Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Iowa Oral Performance Instrument (IOPI)
  IOPI measures the peak pressure of the tongue strength and endurance using a disposable bulb placed on a hard palate behind the front teeth or at the base of the tongue. The participants will be asked to press the bulb with their tongue with maximum pressure, three times. To measure the endurance, the participants will be asked to hold the pressure for as long as they can.
• Диагностический тест Mann Assessment of Swallowing Ability (MASA)
  MASA is a standard clinical swallowing assessment protocol including general patient examination, on-the-outside visible signs of oral preparatory and transportation phase and pharyngeal phase of swallowing function.
• Диагностический тест Fiberoptic Endoscopic Evaluation of Swallowing
  The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).
• Диагностический тест Respiratory function measurements
  Respiratory function measurements will include forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP), all expressed in percentage of predicted values. Conventional methods of testing will be applied.

Первичные конечные точки

• Penetration-Aspiration Scale (PAS) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Yale Residue Severity Rating Scale (YRSRS) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Iowa Oral Performance Instrument (IOPI) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Mann Assessment of Swallowing Ability (MASA) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Eating Assessment Tool 10 (EAT-10) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Swallowing Quality of Life Questionnaire (SWAL-QoL) change [Срок оценки: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion]
• Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]

Вторичные конечные точки (8)

• ALS Functional Rating Scale-Revised (ALSFRS-R) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Functional Oral Intake Scale (FOIS) change [Срок оценки: 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 [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• BMI change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Forced Vital Capacity (FVC) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Peak Cough Flow (PCF) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Maximal Inspiratory Pressure (MIP) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
• Maximal Expiratory Pressure (MEP) change [Срок оценки: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]

Критерии участия

Inclusion Criteria for patients:

• 18 years of age or older
• diagnosis of ALS
• follow-up at University Medical Centre Ljubljana, Division of Neurophysiology, every 3 months
• be able to visit the study site for in-person procedures every 3 months

Inclusion Criteria for relatives:

• at least 18 years of age

Exclusion Criteria for patients:

• co-existing illness or disorder that could influence the swallowing function independently of the ALS diagnosis
• clinically significant cognitive deterioration or dementia at enrollment, as determined by the ALS study neurologist

Exclusion criteria for relatives:

• signs of probable cognitive deterioration or dementia at enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Словения · 1 центр

• University Medical Centre Ljubljana — Ljubljana

Идентификаторы

NCT: NCT05336760 · URIS202201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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