NCT05147597

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 9, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

November 17, 2021

Last Update Submit

April 29, 2025

Conditions

Keywords

SGRQSGRQ-IIPFQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline at 1 week.

Secondary Outcomes (1)

  • Saint George's Respiratory Questionnaire (SGRQ)

    Change from baseline at 1 week.

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTurkish People
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diagnosed with Idiopathic Pulmonary Fibrosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Pehlivan

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

ESRA PEHLİVAN, Assoc.Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 7, 2021

Study Start

January 9, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

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