Sarcoidosis
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
University of East Anglia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Assessment Scale (FAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The global rating of change | Change from 6 weeks to 12 weeks | 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. |
| Short Form 36 (SF-36) | Change from baseline to 12 weeks | 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. |
| Kings' Sarcoidosis Questionnaire (KSQ) | Change from baseline to 12 weeks | 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. |
| Global rating of concept scale | Change from baseline to 12 weeks | 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. |
Countries
United Kingdom
Outcome results
None listed