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Completed

NCT Number: NCT04388085

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

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.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with sarcoidosis
  • Signed informed consent

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Internal consistency

    Time frame: At baseline

    Internal consistency, the interrelatedness of the items in the questionnaire, will be estimated by calculating Cronbach's α for each domain.

  2. Test-retest reliability

    Time frame: 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

  3. Concurrent validity

    Time frame: At baseline

    Concurrent validity was assessed by measuring the correlation of KSQ to other questionnaires

  4. Responsiveness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 14, 2020
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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