Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fatigue Assessment Scale (FAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of another significant cardio-respiratory disease, major organ disease (except where related to sarcoidosis) or chronic inflammatory condition
结局指标
主要结局
Fatigue Assessment Scale (FAS)
时间窗: 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.
次要结局
- Kings' Sarcoidosis Questionnaire (KSQ)(Change from baseline to 12 weeks)
- Global rating of concept scale(Change from baseline to 12 weeks)
- Short Form 36 (SF-36)(Change from baseline to 12 weeks)
- The global rating of change(Change from 6 weeks to 12 weeks)