NCT04388085

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

August 23, 2024

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

May 11, 2020

Last Update Submit

August 22, 2024

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (4)

  • Internal consistency

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

    At baseline

  • 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

  • Concurrent validity

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

    At baseline

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Danish patients with sarcoidosis seen in Department of Respiratory Diseases Aarhus Denmark

You may qualify if:

  • Diagnosed with sarcoidosis
  • Signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Janne Møller, MD

    AU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

December 1, 2019

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

August 23, 2024

Record last verified: 2023-05

Locations

DK(1)