Validity, Reliability and Responsiveness of King's Sarcoidosis Questionnaire in a Danish Population

Completed

• Conditions: Sarcoidosis

• Registration Number: NCT04388085
• Lead Sponsor: University of Aarhus

Brief Summary

The King's Sarcoidosis Questionnaire (KSQ) is a brief questionnaire assessing health status in patients with sarcoidosis. The KSQ was previously validated in English German and Dutch.

KSQ will be translated into Danish and validated in a Danish sarcoidosis population.

Detailed Description

KSQ will be linguistic validated according to existing guidelines. Consecutive patients with sarcoidosis will complete KSQ and other health questionnaires at baseline, after two weeks and 12 months. Concurrent validity, reliability, and responsiveness will be assessed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-14
• Status Verified: 2023-05
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosed with sarcoidosis
• Signed informed consent

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Exclusion Criteria

• Inability or unwillingness to adhere to the study
• Inability to give informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Internal consistency	At baseline	Internal consistency, the interrelatedness of the items in the questionnaire, will be estimated by calculating Cronbach's α for each domain.
Responsiveness	1 year from baseline	Responsiveness: The ability to detect changes over time was assessed by measuring changes in KSQ over 12 months and correlating to changes in other questionnaires
Test-retest reliability	At baseline	Test-retest reliability will be evaluated by Intraclass correlation coefficients (ICC) and Bland- Altman plots comparing KSQ scores at baseline and at 14 days in stable patients
Concurrent validity	At baseline	Concurrent validity was assessed by measuring the correlation of KSQ to other questionnaires

Trial Locations

Locations (1)

Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology; 🇩🇰 Aarhus N, Denmark