Dysphagia, QoL and Attitudes Towards PEG in ALS Patients (ALSDPEG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Diagnostic test: Iowa Oral Performance Instrument (IOPI); Diagnostic test: Mann Assessment of Swallowing Ability (MASA); Diagnostic test: Fiberoptic Endoscopic Evaluation of Swallowing; Diagnostic test: Respiratory function measurements

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Metka Moharić, MD, PhD; Phone Number: +386 1 4758441; Email: metka.moharic@ir-rs.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Medical Centre Ljubljana
    • Contact: Blaž Koritnik, MD, PhD; Phone Number: +386 1 5221501; Email: blaz.koritnik@kclj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALS Patients; Patients with confirmed amyotrophic lateral sclerosis.	Diagnostic test: 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.; Diagnostic test: 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.; Diagnostic test: 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).; Diagnostic test: 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.
Relatives; Close relatives of the patients included in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration-Aspiration Scale (PAS) change	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.	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	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).	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Iowa Oral Performance Instrument (IOPI) change	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.	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	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.	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	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.	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	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).	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	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).	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALS Functional Rating Scale-Revised (ALSFRS-R) change	ALSFRS-R is a 12-tem ALS-specific assessment of global functioning using a five-point scale (0=not able, 4= normal ability), with 48 points representing normal function.	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Functional Oral Intake Scale (FOIS) change	FOIS is a validated 7-point scale demonstrating an individual's ability of daily oral food intake (1=no oral intake, 7=total oral intake with no restrictions).	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	DOSS is a 7-point scale that rates the functional severity of dysphagia based on objective assessment and provides information on diet recommendations, independence level and type of nutrition necessary (level 7=normal swallowing function, level 1=severe dysphagia).	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
BMI change	Body mass index (in kg/m^2)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Forced Vital Capacity (FVC) change	Standard clinical respiratory assessment of FVC (in %)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Peak Cough Flow (PCF) change	Standard clinical respiratory assessment of PCF (in L/min)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Inspiratory Pressure (MIP) change	Standard clinical respiratory assessment of MIP (in cmH2)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Expiratory Pressure (MEP) change	Standard clinical respiratory assessment of MEP (in cmH2)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Collaborators: University Medical Centre Ljubljana
• Investigators: Principal Investigator: Blaž Koritnik, MD, PhD, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: URIS202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No