CABGNCT05023083
Cross Cultural Adaptation of Functional Status Questionnaire in Urdu Language in CABG Patients
An observational study of CABG and Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
Trial summary
Aim of the study is to create an Urdu version of FSQ which will be of great importance for further research in field of cardiopulmonary physiotherapy, specially to make comparison across the population. We therefor aimed to develop a linguistically validated and reliable Urdu version of FSQ. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- CABG, Post-cardiac Surgery
- What is being tested?
- Functional Status Questionnaire Urdu version and Original Functional Status Questionnaire
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 23 May 2021to 23 Nov 2021
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 20 healthy and 50 post CABG patients are included in the study
Who may be able to join
- Able to read Urdu language
- Participating in community
- Patient is in ambulatory condition
- Post coronary artery bypass graft (CABG) Patients
Who cannot join
- Acute Cardiac event (e.g. myocardial infarction (MI), arrhythmia, angina) or intervention (e.g. percutaneous coronary intervention (PCI, valve repair, pacemaker fitting)
- Any other disability or neurological condition Cognitive issue Unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Cultural Adaptation of Functional Status Questionnaire (FSQ) in Urdu Language in CABG Patients
Aim of the study is to create an Urdu version of FSQ which will be of great importance for further research in field of cardiopulmonary physiotherapy, specially to make comparison across the population. We therefor aimed to develop a linguistically validated and reliable Urdu version of FSQ.
Read the detailed description
The Functional Status Questionnaire (FSQ) is a self-administered functional assessment that provides information on the patient's physical, psychological, social and role functions. The Functional Status Questionnaire is easier and more feasible to complete in short duration of time than the long forms. The FSQ was originally developed in English. It has been translated and validated in several languages and showed excellent reliability and responsiveness. The FSQ questionnaire is translated in Urdu to assess general health, ADLs and functional status of Post Coronary artery bypass graft surgery(CABG) patients. Translation will be performed by two independent translators going through all the steps following the guidelines. The two synthesized translations and the two back translations will be merged into one pre- final version of Urdu FSQ. The expert panel will then compare the conceptual equivalence, experiential equivalence, linguistic equivalence and metric equivalence. After this the final version of Urdu FSQ will be evaluated for validity in 50 Post CABG patients after getting their informed consent to participate in the study and their demographic characteristics. Inclusion criteria involves male and female patients of age between 40 to 60 years (ambulatory). Exclusion criteria includes patients with disability that prevent independent walking, acute cardiac condition, neurological conditions, cognitive impaired problem etc. Reliability and validity of FSQ Urdu version will be evaluated. It has been translated and validated in several languages and showed excellent reliability and responsiveness. However up to-date there is no validated Urdu version of the FSQ available. So, it is essential to translate FSQ in Urdu language to make it more comprehensive for local population who doesn't have command on English language. The purpose of this study is cross-cultural translation of the FSQ into Urdu language and to validate it into Urdu speaking population.
Hence, this study is aimed to produce the Urdu version for Urdu speaking countries, it will have a great significance for the physiotherapists, researchers and educators to assess CABG patients general health, QoL, functional status and ADLs where time is short because FSQ makes it easier to collect data from large populations in comparatively lesser time than long assessment forms.
- Conditions
- CABG, Post-cardiac Surgery
- Being tested
- Functional Status Questionnaire Urdu version, Original Functional Status Questionnaire
- Keywords
- ADLs, CABG, Functional Status Questionnaire, FSQ, Quality of life.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Status Questionnaire Urdu versionOther
Also called FSQ Urdu version, UFSQ
The FSQ instrument translated into Urdu consists of only 34 items, main sections addressed physical function in the activities of daily living, psychological function, role function, social function and variety of performance measures.(8) Scores range from a 0 - 4, 1 - 4, and 1 - 6 scale per question depending on section. It increases reliability and patients ease and comfort. Total score range from 0 to 100 higher score represents the more severe condition.
Original Functional Status QuestionnaireOther
Also called FSQ
FSQ was developed to allow the comprehensive and efficient assessment of physical, psychosocial, social, and role functioning in ambulatory patients. It is a self-administered survey that takes approximately 15 min to complete. The results can be scored to produce a one-page report for clinicians to use in their practices. The responses to items within a scale are averaged and transformed to a scale with a potential range of 0 to 100.Higher score represents the more severe condition.
| Study group | Role | What they receive |
|---|---|---|
| diseased individuals | post CABG patients will be included in the study to fill the tool Receives: Other: Functional Status Questionnaire Urdu version; Other: Original Functional Status Questionnaire | |
| healthy individuals | 20 healthy individual will be included to solve questionnaire Receives: Other: Functional Status Questionnaire Urdu version; Other: Original Functional Status Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation of Functional Status Questionnaire(FSQ)
Translation of Functional Status Questionnaire(FSQ) into Urdu Language for using this tool in Pakistani Population who understand Urdu.
Measured: 6 months
Validity of Translated Tool
Validity is assessed for checking that the Translation of Functional Status Questionnaire(FSQ) is valid for using in post-CABG patients in Pakistan.
Measured: 6 months
Reliability of Translated Tool
Reliability is assessed for checking that the Translation of Functional Status Questionnaire(FSQ) is reliable for using in post-CABG patients in Pakistan.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start23 May 2021
- Primary completion23 Oct 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajeeha Zia, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023083
- Sponsor's protocol ID
- REC/Lhr/20/049 Ghazal Jamshaid
- Status last verified
- Apr 2022
- First submitted
- 19 May 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Araujo AM, Miguel JA, Gava EC, de Oliveira BH. Translation and cross-cultural adaptation of an instrument designed for the assessment of quality of life in orthognatic patients. Dental Press J Orthod. 2013 Sep-Oct;18(5):99-106. doi: 10.1590/s2176-94512013000500017.
PubMed 24352395Davide Castagno M, MB BW, Erland Erdmann M, Faiez Zannad M, Remme WJ, Lopez-Sendon JL, et al. Evaluation of the Functional Status Questionnaire in heart. Am J Cardiol. 1996;78:890-5.
Helou AS, Ramos AEB, Oliveira ASB, Quadros AAJ, Fávero FM. The use of functionality scales in patients with Post-Polio Syndrome. Brazilian Journal of Biological Sciences. 2019;6(13):367-79
Cleary PD, Jette AM. Reliability and validity of the Functional Status Questionnaire. Quality of Life Research. 2000;9(1):747-53.
Einarsson G, Grimby G. Disability and handicap in late poliomyelitis. Scand J Rehabil Med. 1990;22(2):113-21.
PubMed 2363025Baker GA, Gagnon D, McNulty P. The relationship between seizure frequency, seizure type and quality of life: findings from three European countries. Epilepsy Res. 1998 May;30(3):231-40. doi: 10.1016/s0920-1211(98)00010-2.
PubMed 9657650van Hout B, Gagnon D, Souetre E, Ried S, Remy C, Baker G, Genton P, Vespignani H, McNulty P. Relationship between seizure frequency and costs and quality of life of outpatients with partial epilepsy in France, Germany, and the United Kingdom. Epilepsia. 1997 Nov;38(11):1221-6. doi: 10.1111/j.1528-1157.1997.tb01220.x.
PubMed 9579924Jette AM, Davies AR, Cleary PD, Calkins DR, Rubenstein LV, Fink A, Kosecoff J, Young RT, Brook RH, Delbanco TL. The Functional Status Questionnaire: reliability and validity when used in primary care. J Gen Intern Med. 1986 May-Jun;1(3):143-9. doi: 10.1007/BF02602324.
PubMed 3772582Febriana D, Juanita J, Nurhasanah N. Psychometric Evaluation of Instruments Measuring The Older Adult's Functional Status in Indonesian. Jurnal Keperawatan Padjadjaran. 2019;7(2)
Akosile CO, Mgbeojedo UG, Maruf FA, Okoye EC, Umeonwuka IC, Ogunniyi A. Depression, functional disability and quality of life among Nigerian older adults: Prevalences and relationships. Arch Gerontol Geriatr. 2018 Jan;74:39-43. doi: 10.1016/j.archger.2017.08.011. Epub 2017 Sep 6.
PubMed 28954240Gallanagh S, Castagno D, Wilson B, Erdmann E, Zannad F, Remme WJ, Lopez-Sendon JL, Lechat P, Follath F, Hoglund C, Mareev V, Sadowski Z, Seabra-Gomes RJ, Dargie HJ, McMurray JJ. Evaluation of the functional status questionnaire in heart failure: a sub-study of the second cardiac insufficiency bisoprolol survival study (CIBIS-II). Cardiovasc Drugs Ther. 2011 Feb;25(1):77-85. doi: 10.1007/s10557-011-6284-x.
PubMed 21287410Swan BA, Maislin G, Traber KB. Symptom distress and functional status changes during the first seven days after ambulatory surgery. Anesth Analg. 1998 Apr;86(4):739-45. doi: 10.1097/00000539-199804000-00012.
PubMed 9539594Murphy N, Confavreux C, Haas J, Konig N, Roullet E, Sailer M, Swash M, Young C, Merot JL. Quality of life in multiple sclerosis in France, Germany, and the United Kingdom. Cost of Multiple Sclerosis Study Group. J Neurol Neurosurg Psychiatry. 1998 Oct;65(4):460-6. doi: 10.1136/jnnp.65.4.460.
PubMed 9771766Tedesco C, Manning S, Lindsay R, Alexander C, Owen R, Smucker ML. Functional assessment of elderly patients after percutaneous aortic balloon valvuloplasty: New York Heart Association classification versus functional status questionnaire. Heart Lung. 1990 Mar;19(2):118-25.
PubMed 2318655
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Cultural Adaptation of Functional Status Questionnaire (FSQ) in Urdu Language in CABG Patients
- ClinicalTrials.gov ID
- NCT05023083
- Acronym / sponsor ID
- REC/Lhr/20/049 Ghazal Jamshaid
- Conditions
- CABG, Post-cardiac Surgery
- Keywords
- ADLs, CABG, Functional Status Questionnaire, FSQ, Quality of life.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 May 2021 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to create an Urdu version of FSQ which will be of great importance for further research in field of cardiopulmonary physiotherapy, specially to make comparison across the population. We therefor aimed to develop a linguistically validated and reliable Urdu version of FSQ.
Detailed description
The Functional Status Questionnaire (FSQ) is a self-administered functional assessment that provides information on the patient's physical, psychological, social and role functions. The Functional Status Questionnaire is easier and more feasible to complete in short duration of time than the long forms. The FSQ was originally developed in English. It has been translated and validated in several languages and showed excellent reliability and responsiveness. The FSQ questionnaire is translated in Urdu to assess general health, ADLs and functional status of Post Coronary artery bypass graft surgery(CABG) patients. Translation will be performed by two independent translators going through all the steps following the guidelines. The two synthesized translations and the two back translations will be merged into one pre- final version of Urdu FSQ. The expert panel will then compare the conceptual equivalence, experiential equivalence, linguistic equivalence and metric equivalence. After this the final version of Urdu FSQ will be evaluated for validity in 50 Post CABG patients after getting their informed consent to participate in the study and their demographic characteristics. Inclusion criteria involves male and female patients of age between 40 to 60 years (ambulatory). Exclusion criteria includes patients with disability that prevent independent walking, acute cardiac condition, neurological conditions, cognitive impaired problem etc. Reliability and validity of FSQ Urdu version will be evaluated. It has been translated and validated in several languages and showed excellent reliability and responsiveness. However up to-date there is no validated Urdu version of the FSQ available. So, it is essential to translate FSQ in Urdu language to make it more comprehensive for local population who doesn't have command on English language. The purpose of this study is cross-cultural translation of the FSQ into Urdu language and to validate it into Urdu speaking population.
Hence, this study is aimed to produce the Urdu version for Urdu speaking countries, it will have a great significance for the physiotherapists, researchers and educators to assess CABG patients general health, QoL, functional status and ADLs where time is short because FSQ makes it easier to collect data from large populations in comparatively lesser time than long assessment forms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diseased individuals | – | Other: Functional Status Questionnaire Urdu version, Other: Original Functional Status Questionnairepost CABG patients will be included in the study to fill the tool |
| healthy individuals | – | Other: Functional Status Questionnaire Urdu version, Other: Original Functional Status Questionnaire20 healthy individual will be included to solve questionnaire |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 healthy and 50 post CABG patients are included in the study
Key inclusion criteria (4 listed)
- Able to read Urdu language
- Participating in community
- Patient is in ambulatory condition
- Post coronary artery bypass graft (CABG) Patients
Key exclusion criteria (2 listed)
- Acute Cardiac event (e.g. myocardial infarction (MI), arrhythmia, angina) or intervention (e.g. percutaneous coronary intervention (PCI, valve repair, pacemaker fitting)
- Any other disability or neurological condition Cognitive issue Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Status Questionnaire Urdu versionAlso: FSQ Urdu version, UFSQThe FSQ instrument translated into Urdu consists of only 34 items, main sections addressed physical function in the activities of daily living, psychological function, role function, social function and variety of performance measures.(8) Scores range from a 0 - 4, 1 - 4, and 1 - 6 scale per question depending on section. It increases reliability and patients ease and comfort. Total score range from 0 to 100 higher score represents the more severe condition. | Other | diseased individuals, healthy individuals |
| Original Functional Status QuestionnaireAlso: FSQFSQ was developed to allow the comprehensive and efficient assessment of physical, psychosocial, social, and role functioning in ambulatory patients. It is a self-administered survey that takes approximately 15 min to complete. The results can be scored to produce a one-page report for clinicians to use in their practices. The responses to items within a scale are averaged and transformed to a scale with a potential range of 0 to 100.Higher score represents the more severe condition. | Other | diseased individuals, healthy individuals |
Primary outcome
Translation of Functional Status Questionnaire(FSQ)
Time frame: 6 months
Translation of Functional Status Questionnaire(FSQ) into Urdu Language for using this tool in Pakistani Population who understand Urdu.
Validity of Translated Tool
Time frame: 6 months
Validity is assessed for checking that the Translation of Functional Status Questionnaire(FSQ) is valid for using in post-CABG patients in Pakistan.
Reliability of Translated Tool
Time frame: 6 months
Reliability is assessed for checking that the Translation of Functional Status Questionnaire(FSQ) is reliable for using in post-CABG patients in Pakistan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 24352395de Araujo AM, Miguel JA, Gava EC, de Oliveira BH. Translation and cross-cultural adaptation of an instrument designed for the assessment of quality of life in orthognatic patients. Dental Press J Orthod. 2013 Sep-Oct;18(5):99-106. doi: 10.1590/s2176-94512013000500017.
- BackgroundDavide Castagno M, MB BW, Erland Erdmann M, Faiez Zannad M, Remme WJ, Lopez-Sendon JL, et al. Evaluation of the Functional Status Questionnaire in heart. Am J Cardiol. 1996;78:890-5.
- BackgroundHelou AS, Ramos AEB, Oliveira ASB, Quadros AAJ, Fávero FM. The use of functionality scales in patients with Post-Polio Syndrome. Brazilian Journal of Biological Sciences. 2019;6(13):367-79
- BackgroundCleary PD, Jette AM. Reliability and validity of the Functional Status Questionnaire. Quality of Life Research. 2000;9(1):747-53.
- Background: PubMed 2363025Einarsson G, Grimby G. Disability and handicap in late poliomyelitis. Scand J Rehabil Med. 1990;22(2):113-21.
- Background: PubMed 9657650Baker GA, Gagnon D, McNulty P. The relationship between seizure frequency, seizure type and quality of life: findings from three European countries. Epilepsy Res. 1998 May;30(3):231-40. doi: 10.1016/s0920-1211(98)00010-2.
- Background: PubMed 9579924van Hout B, Gagnon D, Souetre E, Ried S, Remy C, Baker G, Genton P, Vespignani H, McNulty P. Relationship between seizure frequency and costs and quality of life of outpatients with partial epilepsy in France, Germany, and the United Kingdom. Epilepsia. 1997 Nov;38(11):1221-6. doi: 10.1111/j.1528-1157.1997.tb01220.x.
- Background: PubMed 3772582Jette AM, Davies AR, Cleary PD, Calkins DR, Rubenstein LV, Fink A, Kosecoff J, Young RT, Brook RH, Delbanco TL. The Functional Status Questionnaire: reliability and validity when used in primary care. J Gen Intern Med. 1986 May-Jun;1(3):143-9. doi: 10.1007/BF02602324.
- BackgroundFebriana D, Juanita J, Nurhasanah N. Psychometric Evaluation of Instruments Measuring The Older Adult's Functional Status in Indonesian. Jurnal Keperawatan Padjadjaran. 2019;7(2)
- Background: PubMed 28954240Akosile CO, Mgbeojedo UG, Maruf FA, Okoye EC, Umeonwuka IC, Ogunniyi A. Depression, functional disability and quality of life among Nigerian older adults: Prevalences and relationships. Arch Gerontol Geriatr. 2018 Jan;74:39-43. doi: 10.1016/j.archger.2017.08.011. Epub 2017 Sep 6.
- Background: PubMed 21287410Gallanagh S, Castagno D, Wilson B, Erdmann E, Zannad F, Remme WJ, Lopez-Sendon JL, Lechat P, Follath F, Hoglund C, Mareev V, Sadowski Z, Seabra-Gomes RJ, Dargie HJ, McMurray JJ. Evaluation of the functional status questionnaire in heart failure: a sub-study of the second cardiac insufficiency bisoprolol survival study (CIBIS-II). Cardiovasc Drugs Ther. 2011 Feb;25(1):77-85. doi: 10.1007/s10557-011-6284-x.
- Background: PubMed 9539594Swan BA, Maislin G, Traber KB. Symptom distress and functional status changes during the first seven days after ambulatory surgery. Anesth Analg. 1998 Apr;86(4):739-45. doi: 10.1097/00000539-199804000-00012.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wajeeha Zia, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CABG and Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation of Functional Status Questionnaire(FSQ) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023083, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.