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Completed

NCT Number: NCT05023083

Cross Cultural Adaptation of Functional Status Questionnaire 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.

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Key information

Conditions

CABG Post-cardiac Surgery

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo hospital Lahore

Lahore, Asia, 0054, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to read Urdu language
  • Participating in community
  • Patient is in ambulatory condition
  • Post coronary artery bypass graft (CABG) Patients

Exclusion criteria

  • 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

Treatment and study plan

Functional Status Questionnaire Urdu version

Other

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.

Other names: FSQ Urdu version, UFSQ

Original Functional Status Questionnaire

Other

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.

Other names: FSQ

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Functional Status Questionnaire (FSQ)

    Time frame: 15 min

    The FSQ assesses physical function: basic activities of daily living (BADL) and intermediate activities of daily living (IADL), Mental function, social or role function, social activity and quality of social interaction. The FSQ also contains six single items which ask questions about work status, days spent in bed due to illness, days where the patient had to curtail his/her routine activities because of illness, satisfaction with sexual activities, frequency of social interaction and a question about overall health satisfaction. There are 34 items in the FSQ in total. Using a simple algorithm, computer-generated scores are obtained.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Cross Cultural Adaptation of Functional Status Questionnaire (FSQ) in Urdu Language in CABG Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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