Fatigue in Systemic Lupus Erythematosus
1 other identifier
observational
39
1 country
1
Brief Summary
The aim of this study is to investigate the effects of biopsychosocial status, quality of life, functional status and hematological markers on fatigue in individuals with SLE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2024
CompletedFirst Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedDecember 17, 2024
December 1, 2024
2 months
October 17, 2024
December 15, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Fatigue Assesment Scale
It is a scale consisting 10 items. The maximum score is 50. High score indicates high fatigue.
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
FACIT Fatigue Scale
It is scale consisting 13 items. Scores range from 0-52. High score indicates low fatigue
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary Outcomes (12)
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Short Form 36 (SF-36) Health Survey
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine blood test results
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Routine Blood Test Results
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
- +7 more secondary outcomes
Eligibility Criteria
The study will include individuals aged 18 and older who are receiving treatment for SLE at a university hospital in Turkey, and meet the inclusion and exclusion criteria.
You may qualify if:
- Being diagnosed with SLE according to the 2019 ACR/EULAR diagnostic criteria
- Being 18 years of age or older
You may not qualify if:
- Not being able to speak or understand Turkish fluently
- Having a psychiatric illness that will affect cooperation
- Heart failure or lung pathology that will affect daily life activities
- Additional autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University
Denizli, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assitant
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 22, 2024
Study Start
October 2, 2024
Primary Completion
November 18, 2024
Study Completion
November 30, 2024
Last Updated
December 17, 2024
Record last verified: 2024-12