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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05267405
Other study ID # MAINZ-EPIREG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date January 31, 2024

Study information

Verified date February 2022
Source Johannes Gutenberg University Mainz
Contact Yaroslav Winter, MD, MSc
Phone +496131172234
Email yaroslav.winter@unimedizin-mainz.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Prospective longitudinal observational registry study of all patients with epilepsy treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.


Description:

Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Epileptic or psychogenic seizures Exclusion Criteria: - age<18 - patients who cannot provide informed consent and don't have a legal guardian

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no interventions, only observation
no interventions, only observation

Locations

Country Name City State
Germany Mainz Comprehensive Epilepsy and Sleep Medicine Center Mainz Rheinland-Pfalz

Sponsors (1)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary monthly seizure frequency after 6 months monthly seizure frequency at the follow-up after 6 months 6 months
Primary European Quality of Life 5 dimensions Index (EQ 5D Index) health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state) 6 months
Primary monthly seizure frequency after 12 months monthly seizure frequency at the follow-up after 12 months 12 months
Primary European Quality of Life 5 dimensions Index (EQ 5D Index) health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state) 12 months
Primary Seizure freedom percentage of patients without epileptic seizures 6 months
Primary Seizure freedom percentage of patients without epileptic seizures 12 months
Primary interruption of status epilepticus percentage of patients with interrupted status epilepticus 48 hours
Secondary Resilience Scale 13 Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience 12 months
Secondary Resilience Scale 13 Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience 24 months
Secondary Multidimensional Fatigue Inventory Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores 12 months
Secondary Multidimensional Fatigue Inventory Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores 24 months
Secondary Beck Depression Inventory II Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63) 12 months
Secondary Beck Depression Inventory II Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63) 24 months
Secondary Berlin Social Support Scales (BSSS) Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support 12 months
Secondary Berlin Social Support Scales (BSSS) Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support 24 months
Secondary World Health Organization Quality of Life-BREF (WHOQOL-BREF) World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life) 12 months
Secondary World Health Organization Quality of Life-BREF (WHOQOL-BREF) World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life) 24 months
Secondary Pittsburgh Sleep Quality Index Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality 12 months
Secondary Pittsburgh Sleep Quality Index Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality 24 months
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