Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: 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

• Registration Number: NCT05336760
• Lead Sponsor: University Rehabilitation Institute, Republic of Slovenia

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.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-20
• Study Start: 2023-01-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALS Patients	Fiberoptic Endoscopic Evaluation of Swallowing	Patients with confirmed amyotrophic lateral sclerosis.
ALS Patients	Respiratory function measurements	Patients with confirmed amyotrophic lateral sclerosis.
ALS Patients	Iowa Oral Performance Instrument (IOPI)	Patients with confirmed amyotrophic lateral sclerosis.
ALS Patients	Mann Assessment of Swallowing Ability (MASA)	Patients with confirmed amyotrophic lateral sclerosis.

Primary Outcome Measures

Name	Time	Method
Iowa Oral Performance Instrument (IOPI) change	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	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Functional Oral Intake Scale (FOIS) change	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)	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).
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)	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).
Maximal Inspiratory Pressure (MIP) change	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)	Standard clinical respiratory assessment of MIP (in cmH2)
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)	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.
BMI change	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)	Body mass index (in kg/m\^2)
Forced Vital Capacity (FVC) change	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)	Standard clinical respiratory assessment of FVC (in %)
Peak Cough Flow (PCF) change	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)	Standard clinical respiratory assessment of PCF (in L/min)
Maximal Expiratory Pressure (MEP) change	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)	Standard clinical respiratory assessment of MEP (in cmH2)

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia