IPFNCT05147597
Turkish Validity and Reliability of SGRQ-I
An observational study of IPF, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IPF
- What is being tested?
- Questionnaire
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2022to 1 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with Idiopathic Pulmonary Fibrosis
Who may be able to join
- Be over 18 years old
- Having a Diagnosis of Idiopathic Pulmonary Fibrosis
- To be literate in Turkish
Who cannot join
- Exacerbation or exacerbation in the last 6 weeks
- Presence of comorbidities affecting ambulation
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Validity and Reliability of the Saint George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (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.
Read the detailed description
- 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.
- Conditions
- IPF
- Being tested
- Questionnaire
- Keywords
- SGRQ, SGRQ-I, IPF, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Saint George Respiratory Questionnaire - Idiopathic Pulmonary Fibrosis Version (SGRQ-I)
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.
Measured: Change from baseline at 1 week.
Secondary outcomes (1)
Saint George's Respiratory Questionnaire (SGRQ)
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.
Measured: Change from baseline at 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start9 Jan 2022
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA PEHLIVAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147597
- Sponsor's protocol ID
- TR_SGRQI
- Status last verified
- May 2025
- First submitted
- 17 Nov 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Saint George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I)
- ClinicalTrials.gov ID
- NCT05147597
- Acronym / sponsor ID
- TR_SGRQI
- Conditions
- IPF
- Keywords
- SGRQ, SGRQ-I, IPF, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 7 Dec 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.
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.
Detailed description
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with Idiopathic Pulmonary Fibrosis
Key inclusion criteria (3 listed)
- Be over 18 years old
- Having a Diagnosis of Idiopathic Pulmonary Fibrosis
- To be literate in Turkish
Key exclusion criteria (3 listed)
- Exacerbation or exacerbation in the last 6 weeks
- Presence of comorbidities affecting ambulation
- Cognitive impairment
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 |
|---|---|---|
| QuestionnaireCases 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Saint George's Respiratory Questionnaire (SGRQ)
Time frame: Change from baseline at 1 week.
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IPF, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 30 Sep 2026. 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 Turkey (Türkiye). 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?
Saint George Respiratory Questionnaire - Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (time frame: Change from baseline at 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.