Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426030
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
Validation of Czech Language Versions of Questionnaires for ALS Patients Functional Status and Biomarker Long-term Follow-up
Sponsor:
Masaryk University
Organization:
Masaryk University
Study Overview
Official Title:
Validation of Czech Language Versions of Questionnaires Most Frequently Used for Functional Status Monitoring in Patients With Amyotrophic Lateral Sclerosis and the Long-term Follow-up of Biomarkers of the Disease in These Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Questionnaires and scales used to assess the clinical status and quality of life of patients with amyotrophic lateral sclerosis ALS are an important tool to monitor the disease progression and current needs of patients The use of these tools and in particular their combination allows to cover the whole spectrum of potential patient difficulties and thus significantly facilitates the process of individualisation and optimisation of care The aim of the study was to create and validate the Czech language versions of the following questionnaires or scales 1 ALSFRS-R ALS Functional Rating Scale - Revised Version and 2 ALSFRS-EX EXtended ie extended version of the same scale both in the self-assessment version incl 3 the ALSAQ-40 ALS Assessment Questionnaire including 40 questions 4 the DYALS Dysphagia in ALS and 5 the Borg Dyspnoea Rating Scale
All questionnaires were translated using the forward-backward translation method The scales and questionnaires were administered to ALS patients repeatedly at one-week intervals first in writing during routine patient follow-up at the Neuromuscular Centre of the University Hospital Brno and during repeated administrations by telephone
All questionnaires were translated using the forward-backward translation method The scales and questionnaires were administered to ALS patients repeatedly at one-week intervals first in writing during routine patient follow-up at the Neuromuscular Centre of the University Hospital Brno and during repeated administrations by telephone
Detailed Description:
The first step of the study before patient recruitment began was the linguistic validation of all the scales and questionnaires used Initially Czech language versions were created using the forward-backward translation method These created versions were then discussed by an expert panel consisting of 2 amyotrophic lateral sclerosis experts and 2 translators one native speaker bilingual for both Czech and English one professional translator specialized in medical English
Patients potentially meeting the entry criteria will be informed about the purpose and conduct of the study and will sign an informed consent if they agree to participate in the study
The first administration of all questionnaires including the self-assessment version of the ALSFRS-R ALSFRS-Ex ALSAQ-40 DYALS and Borg Scale for lying standing and moving positions will be performed as part of the patients routine clinical follow-up at the neuromuscular centre The other two administrations of the questionnaires will be done by telephone one and two weeks after inclusion respectively The one-week interval was chosen in line with the approach of similar foreign validation studies of other languages so that there is a high probability of no significant change in the patients clinical condition between repeated administrations and on the other hand that the patient no longer remembers in detail the answers from the previous administration At the first telephone readministration after one week patients will complete the full range of questionnaires as they did at the first administration of the questionnaires at the centre The second telephone readministration after an additional week will involve completion of the ALSFRS-R and -EX questionnaires only and will use the standard version of both questionnaires administered by an assessor certified to use this scale
For patients with significantly limited verbal communication skills it is acceptable to have the patients caregiver mediate the responses during the telephone administration andor to send the completed questionnaires during the follow-up administrations by mail or electronically e-mail In these cases patients will be invited to complete the readministration questionnaires by email or telephone depending on their preference at a time that would be consistent with normal telephone readministrations for other patients to maintain an identical time interval between readministrations Similarly for patients with limited ability to grasp writing instruments it will be permissible to complete questionnaires in collaboration with the caregiver but always on the basis of patient-reported data
At the first administration of all questionnaires including the self-assessment version of the ALSFRS-R questionnaire at the centre the patient will be asked to complete the questionnaires without further clarification from the investigator Similarly during the first telephone readministration involving only the self-assessment questionnaires the individual questions and the options included in them will be read to the patient only with no opportunity for the patient to ask additional questions in order to maintain the self-assessment nature of all tests used
The standard non-self-assessment version of the ALSFRS-R questionnaire will be administered at the second telephone follow-up by TRICALS Treatment Research Initiative to Cure ALS an organisation authorised to use the questionnaire in a certified manner certified assessors and will be administered in accordance with the training provided by this initiative Initial and repeat administrations will be conducted by different raters Evaluators conducting telephone readministrations will not be aware of patients initial test results at the first administration or their clinical status
The procedures for working with human subjects were approved by the Ethics Committee of the Brno University Hospital on 11052023 reference number 06-110522EK project number 8522
Statistical data processing will be performed using SPSS 29 statistical software IBM Corporation 2020 Armonk New York USA
Patients potentially meeting the entry criteria will be informed about the purpose and conduct of the study and will sign an informed consent if they agree to participate in the study
The first administration of all questionnaires including the self-assessment version of the ALSFRS-R ALSFRS-Ex ALSAQ-40 DYALS and Borg Scale for lying standing and moving positions will be performed as part of the patients routine clinical follow-up at the neuromuscular centre The other two administrations of the questionnaires will be done by telephone one and two weeks after inclusion respectively The one-week interval was chosen in line with the approach of similar foreign validation studies of other languages so that there is a high probability of no significant change in the patients clinical condition between repeated administrations and on the other hand that the patient no longer remembers in detail the answers from the previous administration At the first telephone readministration after one week patients will complete the full range of questionnaires as they did at the first administration of the questionnaires at the centre The second telephone readministration after an additional week will involve completion of the ALSFRS-R and -EX questionnaires only and will use the standard version of both questionnaires administered by an assessor certified to use this scale
For patients with significantly limited verbal communication skills it is acceptable to have the patients caregiver mediate the responses during the telephone administration andor to send the completed questionnaires during the follow-up administrations by mail or electronically e-mail In these cases patients will be invited to complete the readministration questionnaires by email or telephone depending on their preference at a time that would be consistent with normal telephone readministrations for other patients to maintain an identical time interval between readministrations Similarly for patients with limited ability to grasp writing instruments it will be permissible to complete questionnaires in collaboration with the caregiver but always on the basis of patient-reported data
At the first administration of all questionnaires including the self-assessment version of the ALSFRS-R questionnaire at the centre the patient will be asked to complete the questionnaires without further clarification from the investigator Similarly during the first telephone readministration involving only the self-assessment questionnaires the individual questions and the options included in them will be read to the patient only with no opportunity for the patient to ask additional questions in order to maintain the self-assessment nature of all tests used
The standard non-self-assessment version of the ALSFRS-R questionnaire will be administered at the second telephone follow-up by TRICALS Treatment Research Initiative to Cure ALS an organisation authorised to use the questionnaire in a certified manner certified assessors and will be administered in accordance with the training provided by this initiative Initial and repeat administrations will be conducted by different raters Evaluators conducting telephone readministrations will not be aware of patients initial test results at the first administration or their clinical status
The procedures for working with human subjects were approved by the Ethics Committee of the Brno University Hospital on 11052023 reference number 06-110522EK project number 8522
Statistical data processing will be performed using SPSS 29 statistical software IBM Corporation 2020 Armonk New York USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None