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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05336760
Recruitment Status : Not yet recruiting
First Posted : April 20, 2022
Last Update Posted : July 5, 2022
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025


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.



Primary Outcome Measures :
  1. Penetration-Aspiration Scale (PAS) change [ Time Frame: 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.

  2. Yale Residue Severity Rating Scale (YRSRS) change [ Time Frame: 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).

  3. Iowa Oral Performance Instrument (IOPI) change [ Time Frame: 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.

  4. Mann Assessment of Swallowing Ability (MASA) change [ Time Frame: 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.

  5. Eating Assessment Tool 10 (EAT-10) change [ Time Frame: 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.

  6. Swallowing Quality of Life Questionnaire (SWAL-QoL) change [ Time Frame: 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).

  7. Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change [ Time Frame: 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).


Secondary Outcome Measures :
  1. ALS Functional Rating Scale-Revised (ALSFRS-R) change [ Time Frame: 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.

  2. Functional Oral Intake Scale (FOIS) change [ Time Frame: 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).

  3. Dysphagia Outcome and Severity Scale (DOSS) change [ Time Frame: 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).

  4. BMI change [ Time Frame: 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)

  5. Forced Vital Capacity (FVC) change [ Time Frame: 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 %)

  6. Peak Cough Flow (PCF) change [ Time Frame: 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)

  7. Maximal Inspiratory Pressure (MIP) change [ Time Frame: 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)

  8. Maximal Expiratory Pressure (MEP) change [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336760


Contacts
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Contact: Metka Moharić, MD, PhD +386 1 4758441 metka.moharic@ir-rs.si

Locations
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Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Contact: Blaž Koritnik, MD, PhD    +386 1 5221501    blaz.koritnik@kclj.si   
Sponsors and Collaborators
University Rehabilitation Institute, Republic of Slovenia
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Blaž Koritnik, MD, PhD University Medical Centre Ljubljana
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Responsible Party: University Rehabilitation Institute, Republic of Slovenia
ClinicalTrials.gov Identifier: NCT05336760    
Other Study ID Numbers: URIS202201
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases