Sjogren's DiseaseNCT07544394
Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study
An observational study of Sjogren's Disease and Fatigue, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Disease, Fatigue
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 20 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of Sjögren's syndrome
- Age ≥ 18 years
- Willingness to participate and provide written informed consent
Who cannot join
- Presence of severe somatic or psychiatric disorders
- Presence of malignancy
- Pregnancy
- Refusal to participate or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaras Sutcu Imam University
Kahramanmaraş
Nazli Elif Nacar, PhD, +90 344 300 40 85, nelifnacar@ksu.edu.tr
About this study
Official title: Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-Month Longitudinal Study
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.
Read the 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.
- Conditions
- Sjogren's Disease, Fatigue
- Medical subject headings
- Sjogren's Syndrome, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3-month
Secondary outcomes (7)
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
ESSDAI is a clinician-reported index assessing systemic disease activity in Sjögren's syndrome across multiple domains including constitutional, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral and central nervous system, hematological, and biological features. Higher scores indicate greater disease activity.
Measured: Baseline and 3-month
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
ESSPRI is a patient-reported outcome measure evaluating fatigue, pain, and dryness using a 0-10 numerical rating scale. The final score is calculated as the mean of the three domains. Higher scores indicate worse symptom severity.
Measured: Baseline and 3-month
Pressure Pain Threshold (PPT)
PPT will be assessed using a digital pressure algometer applied at a constant rate of 50 kPa/s with a 1 cm² probe. Measurements will be taken bilaterally at predefined anatomical sites (trapezius muscle, thumb nail base, and knee). The mean of three consecutive measurements at each site will be recorded. A global PPT value will be calculated by averaging all sites. Higher values indicate lower pain sensitivity.
Measured: Baseline and 3-month
Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item self-report questionnaire assessing anxiety and depression. It consists of two subscales (anxiety and depression), each ranging from 0 to 21. Higher scores indicate greater psychological distress.
Measured: Baseline and 3-month
Pain Catastrophizing Scale (PCS)
The PCS is a 13-item self-report questionnaire assessing catastrophic thinking related to pain. Each item is rated on a 5-point Likert scale (0-4), with total scores ranging from 0 to 52. Higher scores indicate greater levels of pain catastrophizing. The scale includes three subdomains: rumination, magnification, and helplessness.
Measured: Baseline and 3-month
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-reported questionnaire assessing sleep quality over the past month. It generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. The instrument evaluates seven components including sleep quality, latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction.
Measured: Baseline and 3-month
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
The IPAQ-SF is a 7-item questionnaire assessing physical activity levels over the last 7 days, including walking, moderate-intensity, and vigorous-intensity activities. Total physical activity is expressed as MET-minutes per week. Higher scores indicate higher levels of physical activity.
Measured: Baseline and 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start20 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion20 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Elif Nacar, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544394
- Sponsor's protocol ID
- KSU-2026/03-15
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-Month Longitudinal Study
- ClinicalTrials.gov ID
- NCT07544394
- Acronym / sponsor ID
- KSU-2026/03-15
- Conditions
- Sjogren's Disease, Fatigue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 20 Apr 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of Sjögren's syndrome
- Age ≥ 18 years
- Willingness to participate and provide written informed consent
Key exclusion criteria (4 listed)
- Presence of severe somatic or psychiatric disorders
- Presence of malignancy
- Pregnancy
- Refusal to participate or inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multidimensional Fatigue Inventory-20 (MFI-20)
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Disease and Fatigue, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazli Elif Nacar, phd (+90 344 40 85, nelifnacar@ksu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Fatigue Inventory-20 (MFI-20) (time frame: Baseline and 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.