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Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

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 details
    Amyotrophic Lateral Sclerosis

NCT05336760

University Rehabilitation Institute, Republic of Slovenia

26 January 2024

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