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NCT Number: NCT05147597

Turkish Validity and Reliability of SGRQ-I

The Saint George Respiratory Questionnaire (SGRQ) questionnaire is a frequently used questionnaire in the respiratory patient group, and the Turkish version of this questionnaire, which was created for use in idiopathic pulmonary fibrosis patients, is not available. There is no commonly used quality of life questionnaire in patients with idiopathic pulmonary fibrosis. The aim of the study is to translate and validate the SGRQ idiopathic pulmonary fibrosis version of questionnaire into Turkish.

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Key information

Conditions

IPF

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Esra Pehlivan

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location status: Recruiting

Location contact

ESRA PEHLİVAN

CONTACT

[email protected]

02164189616

About this study

  • The study is a cross-sectional, questionnaire validation study.
  • It is planned to complete the study within 2 years after the sufficient sample size is reached and the evaluations are made. The study will be terminated when the sufficient number of patients is reached.
  • The main thing in the application of special tools such as questionnaires is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation phase from the original language to the other language. At this stage, it is ideal for people who know the structure of the target language and the original language well, who have a good command of these languages and who are experienced in doing the translation. In our study, two people who are fluent in the original language will translate the questionnaire into the target language and two different people will translate the original language again.
  • To the participants; Demographic Evaluation Form, Saint George's Respiratory Questionnaire (SGRQ), and SGRQ idiopathic pulmonary fibrosis version of Questionnaire (SGRQ-I) will be applied. The SGRQ-I questionnaire will be administered again one week after the first application date in order to determine the test-retest reliability.
  • Scale reliability will be tested with Cronbach Alpha.For construct validity, confirmatory factor analysis will be applied and confirmatory factor analysis will be applied. For content validity, opinions of different experts will be taken for each item, and the status of items in the scale will be determined according to the results obtained by substituting it. In the logical validity process; Coverage of the components constituting the measured skill for each item will be considered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be over 18 years old
  • Having a Diagnosis of Idiopathic Pulmonary Fibrosis
  • To be literate in Turkish

Exclusion criteria

  • Exacerbation or exacerbation in the last 6 weeks
  • Presence of comorbidities affecting ambulation
  • Cognitive impairment

Treatment and study plan

Questionnaire

Other

Cases diagnosed with Idiopathic pulmonary fibrosis (IPF) in the chest diseases outpatient clinic will be informed about the study, and the informed consent form will be signed by the specialist physician and demographic information will be obtained from the cases who accepted to be included in the study.

The surveys will be contacted by the patient at 1-week intervals and answered by the patient by the responsible researcher and chest diseases physician.

Primary outcomes

  1. Saint George Respiratory Questionnaire - Idiopathic Pulmonary Fibrosis Version (SGRQ-I)

    Time frame: Change from baseline at 1 week.

    SGRQ-I consists of 34 self-complementing items. It was developed as an IPF-specific version of SGRQ. Different scales are used to score the SGRQ-I, resulting in an overall score and three domain scores: Effects, Activities, and Symptoms. Scores range from 0 to 100, with higher scores indicating more impaired health related quality of life.

Secondary outcomes

  1. Saint George's Respiratory Questionnaire (SGRQ)

    Time frame: Change from baseline at 1 week.

    It is a 76-item questionnaire in which the total score and the three-component score are calculated. Components; symptoms (difficulty caused by symptoms such as cough, sputum, shortness of breath, and wheezing), activity (activity that causes or is limited by shortness of breath), and impact (social and psychological impact of the illness). Each item has its own weighted score. These weighted scores are not dependent on age, gender, disease duration and severity. It is not focused on a single language and culture. The evaluation feature of the questionnaire and its distinctiveness in different diseases and at different levels are high. Each of these scores ranges from 0 to 100. 0 indicates best health, 100 indicates worst health.

Study contacts

Contact information is provided by the study sponsor or research team.

ESRA PEHLİVAN, Assoc.Prof.

CONTACT

[email protected]

02164189616

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Turkish Validity and Reliability of the Saint George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2021
Registry last updated
May 1, 2025

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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