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

Sarcoidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04388085
• Other study ID #: SAR2
• Status: Active, not recruiting
• Start date: December 1, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with sarcoidosis

• Signed informed consent

Exclusion Criteria:

• Inability or unwillingness to adhere to the study

• Inability to give informed consent

Related Conditions & MeSH terms

• Sarcoidosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Internal consistency	Internal consistency, the interrelatedness of the items in the questionnaire, will be estimated by calculating Cronbach's a for each domain.	At baseline
Primary	Test-retest reliability	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	At baseline
Primary	Concurrent validity	Concurrent validity was assessed by measuring the correlation of KSQ to other questionnaires	At baseline
Primary	Responsiveness	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	1 year from baseline