Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sjogren's Disease, Fatigue. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-Month Longitudinal Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Multidimensional Fatigue Inventory-20 (MFI-20) [Time frame: Baseline and 3-month]
Secondary outcome measures (7)
- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) [Time frame: Baseline and 3-month]
- EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) [Time frame: Baseline and 3-month]
- Pressure Pain Threshold (PPT) [Time frame: Baseline and 3-month]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline and 3-month]
- Pain Catastrophizing Scale (PCS) [Time frame: Baseline and 3-month]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and 3-month]
- International Physical Activity Questionnaire - Short Form (IPAQ-SF) [Time frame: Baseline and 3-month]
Eligibility criteria
Inclusion criteria
- Diagnosis of Sjögren's syndrome
- Age ≥ 18 years
- Willingness to participate and provide written informed consent
Exclusion criteria
- Presence of severe somatic or psychiatric disorders
- Presence of malignancy
- Pregnancy
- Refusal to participate or inability to provide written informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Kahramanmaras Sutcu Imam University — Kahramanmaraş
Identifiers
NCT: NCT07544394 · KSU-2026/03-15