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

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.

Study Overview

• Status: Unknown
• Conditions: Sarcoidosis

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR47TJ
      • Norwich Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with sarcoidosis and fatigue

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of East Anglia
• Collaborators: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2019
• Primary Completion (ACTUAL): May 10, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• Other Study ID Numbers: IRAS ID 248633

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No