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

April 21, 2022 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Asia
      • Lahore, Asia, Pakistan, 0054
        • Mayo Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 healthy and 50 post CABG patients are included in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diseased individuals
post CABG patients will be included in the study to fill the tool
Other: Functional Status Questionnaire Urdu version
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
Other: Original Functional Status Questionnaire
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
healthy individuals
20 healthy individual will be included to solve questionnaire
Other: Functional Status Questionnaire Urdu version
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
Other: Original Functional Status Questionnaire
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Wajeeha Zia, MSPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2021

Primary Completion (Actual)

October 23, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC/Lhr/20/049 Ghazal Jamshaid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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