SarcoidosisNCT04508361
Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire
An observational study of Sarcoidosis, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This study aims to see if people's health related quality of life (how they feel about their health) changes over a 12 week period if they do not receive any change in their medicines. The investigators would like people to complete four questionnaires then repeat them after three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2019to 1 Nov 2020
- 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: People with sarcoidosis and fatigue
Who may be able to join
- Male or Female aged over 18
- Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting diagnosis of sarcoidosis
- Significant fatigue - defined as a FAS score of greater than 21 points
- Has mental capacity to complete the questionnaires
Who cannot join
- Presence of another significant cardio-respiratory disease, major organ disease (except where related to sarcoidosis) or chronic inflammatory condition
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to see if people's health related quality of life (how they feel about their health) changes over a 12 week period if they do not receive any change in their medicines. The investigators would like people to complete four questionnaires then repeat them after three months. The investigators need to do this to in order see what difference they should expect to detect if they give people treatment that works.
Read the detailed description
Study Design This will be a questionnaire study, which will involve administering questionnaires to patients with sarcoidosis at baseline and after six and 12 weeks.
Participants can either complete the questionnaires whilst they are attending clinic, or alternatively return the questionnaires via a pre-paid postal envelope. The questionnaires will be administered at the same time; no other study measures will be taken subsequently. Demographic and clinical information will be collected from the patients' medical records.
- Conditions
- Sarcoidosis
- Medical subject headings
- Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment Scale (FAS)
Fatigue Assessment Scale (FAS) - ranges from 10 to 50 with higher values representing greater fatigue. There are a specified cut-off values for clinically significant fatigue (score >= 22) and severe fatigue (score >= 35).The questionaire was administered at baseline, 6 weeks and 12 weeks.
Measured: Change from baseline to 12 weeks
Secondary outcomes (4)
Short Form 36 (SF-36)
Short Form 36 (SF-36) -ranges between 0 (maximum disability) and 100 (no disability). The SF36 score can be converted to utility scores using values within the questionnaire. The questionaire was administered at baseline, 6 weeks and 12 weeks.
Measured: Change from baseline to 12 weeks
Kings' Sarcoidosis Questionnaire (KSQ)
Kings' Sarcoidosis Questionnaire (KSQ) ranges between 0 and 100 with higher numbers representing better health. The questionaire was administered at baseline, 6 weeks and 12 weeks.
Measured: Change from baseline to 12 weeks
Global rating of concept scale
Global rating of concept scale. This is a ranking between 6 options to rate overall quality of life from no problem to very severe problem. The questionaire was administered at baseline, 6 weeks and 12 weeks.
Measured: Change from baseline to 12 weeks
The global rating of change
The global rating of change. This is a scoring out of 15 options to rate change in quality of life. It ranges between -7 and 7 with positive values representing an improvement. The questionaire was administered at 6 weeks and 12 weeks.
Measured: Change from 6 weeks to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start19 Apr 2019
- Primary completion10 May 2020
- Study completion1 Nov 2020 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508361
- Sponsor's protocol ID
- IRAS ID 248633
- Status last verified
- Aug 2020
- First submitted
- 10 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire
- ClinicalTrials.gov ID
- NCT04508361
- Acronym / sponsor ID
- IRAS ID 248633
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 11 Aug 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.
This study aims to see if people's health related quality of life (how they feel about their health) changes over a 12 week period if they do not receive any change in their medicines. The investigators would like people to complete four questionnaires then repeat them after three months. The investigators need to do this to in order see what difference they should expect to detect if they give people treatment that works.
Detailed description
Study Design This will be a questionnaire study, which will involve administering questionnaires to patients with sarcoidosis at baseline and after six and 12 weeks.
Participants can either complete the questionnaires whilst they are attending clinic, or alternatively return the questionnaires via a pre-paid postal envelope. The questionnaires will be administered at the same time; no other study measures will be taken subsequently. Demographic and clinical information will be collected from the patients' medical records.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with sarcoidosis and fatigue
Key inclusion criteria (4 listed)
- Male or Female aged over 18
- Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting diagnosis of sarcoidosis
- Significant fatigue - defined as a FAS score of greater than 21 points
- Has mental capacity to complete the questionnaires
Key exclusion criteria (1 listed)
- Presence of another significant cardio-respiratory disease, major organ disease (except where related to sarcoidosis) or chronic inflammatory condition
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
Fatigue Assessment Scale (FAS)
Time frame: Change from baseline to 12 weeks
Fatigue Assessment Scale (FAS) - ranges from 10 to 50 with higher values representing greater fatigue. There are a specified cut-off values for clinically significant fatigue (score >= 22) and severe fatigue (score >= 35).The questionaire was administered at baseline, 6 weeks and 12 weeks.
4 secondary outcomes
Short Form 36 (SF-36)
Time frame: Change from baseline to 12 weeks
Kings' Sarcoidosis Questionnaire (KSQ)
Time frame: Change from baseline to 12 weeks
Global rating of concept scale
Time frame: Change from baseline to 12 weeks
The global rating of change
Time frame: Change from 6 weeks to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 East Anglia at 1 site in United Kingdom.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Fatigue Assessment Scale (FAS) (time frame: Change from baseline to 12 weeks). 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 11 Aug 2020; AzTrials last refreshed its copy on 1 Nov 2026.