Study Purpose:
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 Status:
Not yet recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Blaž Koritnik, MD, PhD, University Medical Centre Ljubljana
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Metka Moharić, MD, PhD / email hidden; JavaScript is required / +386 1 4758441
Full Study Summary:
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 Sponsor:
University Rehabilitation Institute, Republic of Slovenia
Estimated Enrollment:
60
Estimated Study Start Date:
08 / 01 / 2022
Estimated Study Completion Date:
03 / 31 / 2025
Posting Last Modified Date:
07 / 05 / 2022
Date Study Added to neals.org:
04 / 20 / 2022
Minimum Age:
18 Years
Maximum Age:
N/A
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
University Medical Centre Ljubljana
Blaž Koritnik, MD, PhD / +386 1 5221501 / email hidden; JavaScript is required
Ljubljana 1000
Slovenia