An observational study in Tick-Borne Encephalitis, European, sponsored by Sykehuset Telemark. Active, not recruiting at 3 sites in Norway. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Sykehuset Telemark · Observational
During 2018, 2019, and 2020, the reported TBE-cases have increased markedly in Norway. Surveillance studies conducted by the Norwegian Institute of Public Health demonstrate that cases are associated with tick bites in the coastal areas of the Agder, Buskerud, and Vestfold and Telemark counties There is a urgent need for more knowledge of the consequences of TBE in Norway, in particular the identification of patients at risk of long-term sequela. Hence, the overall objective of this project is to gain more knowledge about the natural course of TBE in Norway, and its impact on long-term health-related quality of life and associated factors. Clinical data, biological sampling and PROMs are collected from TBE-infected patients admitted to three hospitals within the epidemic region in Norway.
This project is designed as a multicenter study divided into four sub-studies:
Substudy 1: A retrospective descriptive study of the clinical features and objective findings of the acute phase of the TBE-patients diagnosed with TBE in South-East Norway during 2018, 2019 and 2020.
Substudy 2: A prospective multicenter study of health related QOL one year after hospitalization with TBE in South-East Norway from 2019 - 2023. The self-reported health-related QOL (assesedby SF-36) of the TBE-patients will be compared with the SF-36 reference values in the Norwegian population.
Substudy 3: A prospective multicenter study of self-reported cognitive function one year after hospitalization with TBE in South-East Norway from 2019- 2023. The cognitive function, measured by PROMS, will be compared with PROMS from an included reference group from the patient's social environment.
Substudy 4: Analyses of biological samples collected at baseline, 3 months and 12 months after hospitalization for TBE in patients included in substudy 2 and 3. These analyses will be conducted to gain more knowledge of the pathogenesis of TBE infection and in particular, which molecular pathways and biomarkers that characterize the TBE infected patients who are hospitalized in Norway. Analyses to identify associations between the acute inflammatory response and long-term outcome will be performed.
51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.
This study's enrollment of 153 is below the median of 500 across 11 observational studies indexed under Encephalitis, Tick-Borne.
Browse Encephalitis, Tick-Borne studies →Sykehuset Telemark is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population in substudy 1. Patients > 16 years old diagnosed with acute infection caused by TBEV. The hospitals involved are Telemark and Vestfold. Study population in substudy 2. Patients > 16 years old diagnosed with acute infection caused by TBEV. The hospitals involved are Telemark, Vestfold and Sørlandet.
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Exclusion Criteria:
No intervention
To describe the acute phase clinical and immunological characteristics of TBE in Norway
clinical features and objective findings of the acute phase of the TBE-patients diagnosed with TBE in South-East Norway during 2018-2021
Time frame: 4 years
To investigate the impact of TBEV infection on health-related QOL in a one year follow-up study of a Norwegian patient cohort
A prospective multicenter study of health-related QOL one year after hospitalization with TBE in South-East Norway from 2019-2022. The self-reported health-related QOL (assessed by SF-36) of the TBE-patients, will be compared with the SF-36 reference values in the Norwegian population.
Time frame: 4 years
To investigate the impact of TBEV infection on long-term cognitive function in a one year follow-up study of a Norwegian patient cohort
A prospective multicenter study of self-reported cognitive function by BRIEF, FSS, HADS and EMQ, one year after hospitalization with TBE in South-East Norway from 2019-2022. The cognitive function, measured by PROMS, will be compared with PROMS from an included reference group from the patient's social environment.
Time frame: 5 years
To identify biomarkers in the cerebrospinal fluid (CSF) and blood, which serve as predictors for TBE severity and long-term complaints
FS-36 and BRIEF
Time frame: 5 years
Plan to share: No
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Sykehuset Telemark