Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-Month Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Multidimensional Fatigue Inventory-20 (MFI-20)
研究概览
简要总结
This prospective longitudinal study will be conducted in patients diagnosed with Sjögren's disease who are followed at the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Demographic and clinical data will be collected from routine clinical assessments and medical records, including laboratory results obtained during standard care.
Participants will undergo evaluation of pressure pain threshold using a digital algometer and complete validated questionnaires assessing fatigue, disease activity, patient-reported symptoms, anxiety and depression, pain catastrophizing, sleep quality, and physical activity level.
All assessments will be performed at baseline and repeated at follow-up visits approximately 3 months later.
详细描述
This prospective longitudinal study aims to investigate predictors of fatigue and its associations with clinical and biopsychosocial factors in patients with Sjögren's disease.
The study will be conducted in the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Adult patients diagnosed with Sjögren's disease and followed in routine clinical care will be included.
Baseline assessments will include demographic and clinical data collection from medical records and routine laboratory tests. In addition, participants will undergo evaluation of pain sensitivity using pressure pain threshold (PPT) measurement and complete validated questionnaires assessing fatigue, disease activity, patient-reported symptoms, anxiety and depression, pain catastrophizing, sleep quality, and physical activity.
Follow-up assessments will be performed approximately 3 months later and all baseline measurements will be repeated.
The primary aim of the study is to evaluate whether baseline clinical and biopsychosocial variables explain variations in fatigue over time. Secondary aims include examining the associations between fatigue and pain sensitivity, psychological status, sleep quality, and physical activity levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Diagnosis of Sjögren's syndrome
- •Age ≥ 18 years
- •Willingness to participate and provide written informed consent
排除标准
- •Presence of severe somatic or psychiatric disorders
- •Presence of malignancy
- •Pregnancy
- •Refusal to participate or inability to provide written informed consent
结局指标
主要结局
Multidimensional Fatigue Inventory-20 (MFI-20)
时间窗: Baseline and 3-month
The MFI-20 is a 20-item self-reported questionnaire assessing fatigue across five dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each item is scored on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating greater fatigue.
次要结局
- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)(Baseline and 3-month)
- EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)(Baseline and 3-month)
- Pressure Pain Threshold (PPT)(Baseline and 3-month)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and 3-month)
- Pain Catastrophizing Scale (PCS)(Baseline and 3-month)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and 3-month)
- International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Baseline and 3-month)
研究者
Nazli Elif Nacar
Physiotherapist, PhD
Kahramanmaras Sutcu Imam University