Clinical trial NCT05336760: Dysphagia, QoL and Attitudes Towards PEG in ALS Patients
Official title: Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
Collaborators: name: University Medical Centre Ljubljana
First posted: 2022-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adult ALS patients able to visit the study site for in-person procedures every 3 months, and their close relatives.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Penetration-Aspiration Scale (PAS) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Yale Residue Severity Rating Scale (YRSRS) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Iowa Oral Performance Instrument (IOPI) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Mann Assessment of Swallowing Ability (MASA) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Eating Assessment Tool 10 (EAT-10) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Swallowing Quality of Life Questionnaire (SWAL-QoL) change
timeFrame: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion
measure: Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary outcomes:
measure: ALS Functional Rating Scale-Revised (ALSFRS-R) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Functional Oral Intake Scale (FOIS) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Dysphagia Outcome and Severity Scale (DOSS) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: BMI change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Forced Vital Capacity (FVC) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Peak Cough Flow (PCF) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Maximal Inspiratory Pressure (MIP) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
measure: Maximal Expiratory Pressure (MEP) change
timeFrame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Blaž Koritnik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: