Polish Version Dyspnea in Amyotrophic Lateral Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of Polish Language Version of Dyspnea in Amyotrophic Lateral Sclerosis Outcome Measure
Overview
Amyotrophic lateral sclerosis is a fatal disease with progressive degeneration of central and peripheral motor neurons. Weakness of pharyngeal and respiratory muscles lead to dyspnea, which is present in up to 80% of patients. Dyspnea in Amyotrophic Lateral Sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. The aim of this study is to validate the Polish-language version of DALS-15.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive degeneration of central and peripheral motor neurons with death occurring usually three to five years after onset. Weakness of pharyngeal and respiratory muscles lead to chronic dyspnea, which is present in up to 80% of patients and which contributes to anxiety, depression, and significant decrease of the quality of life. Moreover, these symptoms, along with daytime sleepiness or apathy may mask the dyspnea itself and the patient may stay unaware of increasing respiratory insufficiency. Recognizing the time of the onset of respiratory insufficiency is on the other hand important for the planning of respiratory assistance therapy, which in ALS includes continuous positive airway pressure, as well as the noninvasive and the invasive ventilation. Dyspnea in amyotrophic lateral sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. It is a 15-item tool. Particular items are descriptions of the severity of subjective dyspnea or refer to daily consequences of dyspnea such as avoiding the sleep in supine position or refer to the situations when dyspnea may occur, such as physical effort. Each item may be answered with "never", "occasionally" or "often", which are scored 0, 1 and 2, respectively. The total, arithmetical score, which ranges from 0 to 30 is then transformed according to the provided table into an interval score, which reflects the impact of dyspnea more accurately. The original DALS-15 showed excellent psychometric properties and has been already validated for Turkish language. The aim of this study is to validate the Polish-language version of DALS-15.
Primary outcome measures
- Convergent Validity - Modified Borg Dyspnea Scale upright [Time frame: Through study completion, an average of 1 year.]
- Convergent Validity - Modified Borg Dyspnea Scale supine [Time frame: Through study completion, an average of 1 year.]
- Reliability [Time frame: Through study completion, an average of 1 year.]
- Internal Consistency [Time frame: Through study completion, an average of 1 year.]
Secondary outcome measures (3)
- Convergent Validity - ALSFRS-r [Time frame: Through study completion, an average of 1 year.]
- Impact of fatigue on quality of life - index [Time frame: Through study completion, an average of 1 year.]
- Impact of fatigue on quality of life - visual analogue scale [Time frame: Through study completion, an average of 1 year.]
Eligibility criteria
Inclusion criteria
- Diagnosis of definite ALS, or probable ALS or probable, laboratory supported ALS according to revised Escorial criteria \[Brooks et al. 2000\].
- Complaining of dyspnea on exertion, or dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea.
Exclusion criteria
- Cognitive impairment severe enough to interfere with study process.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available. PMID 11464847
Identifiers
NCT: NCT07178574 · Jagiellonian U76