SarcoidosisNCT04388085
Validity, Reliability and Responsiveness of King's Sarcoidosis Questionnaire in a Danish Population
An observational study of Sarcoidosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2019to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Danish patients with sarcoidosis seen in Department of Respiratory Diseases Aarhus Denmark
Who may be able to join
- Diagnosed with sarcoidosis
- Signed informed consent
Who cannot join
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology
Aarhus N, 8200
About this study
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.
Read the 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.
- Conditions
- Sarcoidosis
- Medical subject headings
- Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal consistency
Internal consistency, the interrelatedness of the items in the questionnaire, will be estimated by calculating Cronbach's α for each domain.
Measured: 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
Measured: At baseline
Concurrent validity
Concurrent validity was assessed by measuring the correlation of KSQ to other questionnaires
Measured: 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
Measured: 1 year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Dec 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janne Møller, MD, Principal investigator, AU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388085
- Sponsor's protocol ID
- SAR2
- Status last verified
- May 2023
- First submitted
- 11 May 2020
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability and Responsiveness of King's Sarcoidosis Questionnaire in a Danish Population
- ClinicalTrials.gov ID
- NCT04388085
- Acronym / sponsor ID
- SAR2
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish patients with sarcoidosis seen in Department of Respiratory Diseases Aarhus Denmark
Key inclusion criteria (2 listed)
- Diagnosed with sarcoidosis
- Signed informed consent
Key exclusion criteria (2 listed)
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Concurrent validity
Time frame: At baseline
Concurrent validity was assessed by measuring the correlation of KSQ to other questionnaires
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Møller, MD principal investigator
AU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.