Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483620
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-11
Brief Title:
Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Neuropathy and Foot Ulcer_ Specific Quality of Life Instrument Neuro QOL Arabic Version Cross-cultural Adaptation Validity and Reliability for Patients With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-07
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:
PURPOSE This study will translate culturally adapt validate and test the reliability of the Neuro Qol Arabic version to be used with diabetic patients in Arabic countries
Background The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument is a multidimensional scale was developed to assess the QoL of diabetic patients with peripheral neuropathy Producing Arabic versions of the Translating Scale can help researchers investigate offloading treatment among the Arabic population with DFUs
Hypotheses The study design was a cross-cultural validation of NeuroQol the Arabic version for patients with DFUs
Research Question Will there be cultural adaptation validation and reliability between the Neuro Qol Arabic version and the original language
Background The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument is a multidimensional scale was developed to assess the QoL of diabetic patients with peripheral neuropathy Producing Arabic versions of the Translating Scale can help researchers investigate offloading treatment among the Arabic population with DFUs
Hypotheses The study design was a cross-cultural validation of NeuroQol the Arabic version for patients with DFUs
Research Question Will there be cultural adaptation validation and reliability between the Neuro Qol Arabic version and the original language
Detailed Description:
The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument Neuro QOL is used worldwide to assess the QOL of diabetic patients with peripheral neuropathy There is no Arabic version of NeuroQOL for use in Egypt
The study design will be a cross-cultural validation of Neuro Qol the Arabic version for patients with DFUs Three expert panels were involved in this study to test the face and content validity of Neuro Qol Arabic version All experts had experience of not less than 10 years or at least a masters degree in physical therapy a major part of their work is with Arabic population and they were also fluent in Arabic and English
Ten patients per item were chosen to estimate the sample size for testing the psychometric properties of the Neuro Qol Arabic version So 290 patients 145 male patients and 145 female patients were chosen according to the following criteria Their age ranged between 18-70 years with type 2 diabetes referred by physician conscious and ambulant and being able to read and write in Arabic
Patients suffering from congenital deformities fixed spinal deformity rheumatoid arthritis bone disease or infection were excluded from the study
Participants will be identified approached and recruited from outpatient clinics at the Faculty of Physical Therapy Nahda University and El-Salam University The study will be advertised through posters and word of mouth Participants will receive a participant information sheet and a self-screening eligibility form and they will be asked to contact the Principal Investigator SG no sooner than 48 hours if they wish to volunteer to participate in the study which consisted of two visits to the clinic
During study visit 1 participants will be briefed about the study screened for eligibility and enrolled in the study by signing a consent form
Demographic data such as age weight and height will also be collected to describe the sample The principal investigator will apply the clinical examination for the foot and assess any problems such as lost or reduced feeling in your extremities pain discomfort andor ulcers open sores on your feet and in some cases unsteadiness while walking or standing Participants will then complete the Arabic NeuroQOL A nurse assisted participants with reading difficulties
Participants will return for study visit 2 after 7-14 days and will complete the Michigan Diabetic Neuropathy Scale MDNS-Arabic version Participants will also be required to report other symptoms and complications associated with diabetes
The translation process will follow the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcome Measures using the following steps
1 Preparation Four bilingual translators who are fluent in Arabic and English will be selected Three translators are clinicians and one translator is a university academic
2 Forward translation the NeuroQOL will be given to all translators to translate into Arabic
3 Reconciliation The four translated documents will be shared between all translators and discrepancies ambiguities and issues arising will be discussed and resolved and a final draft Arabic version of the NeuroQOL will be produced
4 Backward translation and review The final draft Arabic version of the NeuroQOL will be translated back into English by a translator who had not been involved in forward translation and who was blind to the original English version of the NeuroQOL
5 Harmonization cognitive debriefing and reviewing of results The back-translated The English version of the NeuroQOL will be compared with the original NeuroQOL and discrepancies ambiguities and typographic andor grammatical errors will be discussed within the group and in the final draft of the Arabic version
6 Proofreading and final report When the authenticity of the translation has been agreed upon by consensus the final version of the Arabic-NeuroQOL will be produced
The study design will be a cross-cultural validation of Neuro Qol the Arabic version for patients with DFUs Three expert panels were involved in this study to test the face and content validity of Neuro Qol Arabic version All experts had experience of not less than 10 years or at least a masters degree in physical therapy a major part of their work is with Arabic population and they were also fluent in Arabic and English
Ten patients per item were chosen to estimate the sample size for testing the psychometric properties of the Neuro Qol Arabic version So 290 patients 145 male patients and 145 female patients were chosen according to the following criteria Their age ranged between 18-70 years with type 2 diabetes referred by physician conscious and ambulant and being able to read and write in Arabic
Patients suffering from congenital deformities fixed spinal deformity rheumatoid arthritis bone disease or infection were excluded from the study
Participants will be identified approached and recruited from outpatient clinics at the Faculty of Physical Therapy Nahda University and El-Salam University The study will be advertised through posters and word of mouth Participants will receive a participant information sheet and a self-screening eligibility form and they will be asked to contact the Principal Investigator SG no sooner than 48 hours if they wish to volunteer to participate in the study which consisted of two visits to the clinic
During study visit 1 participants will be briefed about the study screened for eligibility and enrolled in the study by signing a consent form
Demographic data such as age weight and height will also be collected to describe the sample The principal investigator will apply the clinical examination for the foot and assess any problems such as lost or reduced feeling in your extremities pain discomfort andor ulcers open sores on your feet and in some cases unsteadiness while walking or standing Participants will then complete the Arabic NeuroQOL A nurse assisted participants with reading difficulties
Participants will return for study visit 2 after 7-14 days and will complete the Michigan Diabetic Neuropathy Scale MDNS-Arabic version Participants will also be required to report other symptoms and complications associated with diabetes
The translation process will follow the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcome Measures using the following steps
1 Preparation Four bilingual translators who are fluent in Arabic and English will be selected Three translators are clinicians and one translator is a university academic
2 Forward translation the NeuroQOL will be given to all translators to translate into Arabic
3 Reconciliation The four translated documents will be shared between all translators and discrepancies ambiguities and issues arising will be discussed and resolved and a final draft Arabic version of the NeuroQOL will be produced
4 Backward translation and review The final draft Arabic version of the NeuroQOL will be translated back into English by a translator who had not been involved in forward translation and who was blind to the original English version of the NeuroQOL
5 Harmonization cognitive debriefing and reviewing of results The back-translated The English version of the NeuroQOL will be compared with the original NeuroQOL and discrepancies ambiguities and typographic andor grammatical errors will be discussed within the group and in the final draft of the Arabic version
6 Proofreading and final report When the authenticity of the translation has been agreed upon by consensus the final version of the Arabic-NeuroQOL will be produced
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