Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire

Sarcoidosis Clinical Trial

Official title:

Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04508361
• Other study ID #: IRAS ID 248633
• Status: Active, not recruiting
• Start date: April 19, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: August 2020
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The investigators need to do this to in order see what difference they should expect to detect if they give people treatment that works.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 1, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Presence of another significant cardio-respiratory disease, major organ disease (except where related to sarcoidosis) or chronic inflammatory condition

Related Conditions & MeSH terms

• Fatigue
• Sarcoidosis

Locations

Country	Name	City	State
United Kingdom	Norwich Medical School	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
University of East Anglia	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 12 weeks
Secondary	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.	Change from baseline to 12 weeks
Secondary	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.	Change from baseline to 12 weeks
Secondary	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.	Change from baseline to 12 weeks
Secondary	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.	Change from 6 weeks to 12 weeks