Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study

NCT07544394 | Recruiting

• 1 other identifier: KSU-2026/03-15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sjogren's Disease; Fatigue

Outcome Measures

Primary Outcomes (1)

• Multidimensional Fatigue Inventory-20 (MFI-20)

  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.

  Baseline and 3-month

Secondary Outcomes (7)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the rheumatology outpatient clinics of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. The study population will consist of adult patients diagnosed with Sjögren's disease who are followed in routine clinical care.

You may qualify if:

• Diagnosis of Sjögren's syndrome
• Age ≥ 18 years
• Willingness to participate and provide written informed consent

You may not qualify if:

• Presence of severe somatic or psychiatric disorders
• Presence of malignancy
• Pregnancy
• Refusal to participate or inability to provide written informed consent

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome; Fatigue

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nazli Elif Nacar, phd

CONTACT

+90 344 40 85; nelifnacar@ksu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 20, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TU (1)