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

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Summary

This study registers a prospective longitudinal investigation examining fatigue predictors in patients diagnosed with Sjögren's disease over a 3-month period at Kahramanmaras Sutcu Imam University Medical Faculty Hospital. The study will collect demographic and clinical data including laboratory results, pressure pain threshold measurements using a digital algometer, and validated questionnaires assessing fatigue, disease activity, symptoms, anxiety, depression, pain catastrophizing, sleep quality, and physical activity at baseline and 3-month follow-up. This clinical trial registration does not create compliance obligations for regulated entities — it is an informational record of planned research.

“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.”

NIH , verbatim from source
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GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 686 changes logged to date.

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This study registers a prospective longitudinal investigation examining fatigue predictors in patients diagnosed with Sjögren's disease over a 3-month period. The study will be conducted at a single rheumatology outpatient clinic in Turkey, collecting clinical assessments, laboratory results, pressure pain thresholds, and validated questionnaire data at baseline and 3-month follow-up. For clinical researchers and rheumatologists, this trial contributes to the understanding of fatigue mechanisms in Sjögren's disease and may inform future therapeutic approaches. Healthcare institutions with rheumatology departments conducting similar patient-reported outcome research may find this study relevant for methodology comparison.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Observational NCT07544394 Kind: OBSERVATIONAL Apr 22, 2026

Abstract

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

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Patients Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical research Patient assessment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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