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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04388085
Enrollment
150
Registered
2020-05-14
Start date
2019-12-01
Completion date
2024-04-30
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

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.

Interventions

None listed

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with sarcoidosis * Signed informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Internal consistencyAt baselineInternal consistency, the interrelatedness of the items in the questionnaire, will be estimated by calculating Cronbach's α for each domain.
Test-retest reliabilityAt baselineTest-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 validityAt baselineConcurrent validity was assessed by measuring the correlation of KSQ to other questionnaires
Responsiveness1 year from baselineResponsiveness: The ability to detect changes over time was assessed by measuring changes in KSQ over 12 months and correlating to changes in other questionnaires

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026