Polish Version Dyspnea in Amyotrophic Lateral Sclerosis
ConditionAmyotrophic Lateral Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJakub Antczak
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Cognitive impairment severe enough to interfere with study process.
Trial population
Patients who suffer of amyotrophic lateral sclerosis (named also motor neuron disease, Lou Gehrig's disease or Charcot's disease) and have breathlessness or shortness of breath due to this disease. Eligible patients cannot have problems with breathing because of other conditions such as heart or lung diseases. They also must not suffer from mental problems severe enough to cause problems with understanding of scales and questionaires used in the study.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: ALS patients
Trial outcomes
Primary outcomes
1
Convergent Validity - Modified Borg Dyspnea Scale upright
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in upright position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 year.2
Convergent Validity - Modified Borg Dyspnea Scale supine
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in supine position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 year.3
Reliability
Reliability will be tested by calculating the correlation between Polish language version of DALS-15 scores from the 1st and 2nd administration in the randomly selected subgroup of patients. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 year.4
Internal Consistency
Consistency between particular items of Polish language version of DALS-15 will be evaluated using Cronbach alfa test. The score of the Polish language version of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 year.Secondary outcomes
1
Convergent Validity - ALSFRS-r
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of the respiratory part (items 10-12) of Polish-language version of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of the respiratory part of ALSFRS-R ranges between 0 and 12 with higher scores meaning a better outcome.
Time frame
Through study completion, an average of 1 year.2
Impact of fatigue on quality of life - index
Correlation between DALS-15 and the index score of EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The index score of EQ-5D-5L questionnaire ranges between -0.59 to 1 with higher scores indicating better outcome.
Time frame
Through study completion, an average of 1 year.3
Impact of fatigue on quality of life - visual analogue scale
Correlation between DALS-15 and the visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire ranges between 0 to 100 with higher scores indicating better outcome.
Time frame
Through study completion, an average of 1 year.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jakub Antczak
Lead sponsor
Jagiellonian University
Sponsor institution
Source ClinicalTrials.gov
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