MAINZ-EPIREG: Mainz Epilepsy Registry
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
- monthly seizure frequency after 6 months [6 months]
monthly seizure frequency at the follow-up after 6 months
- European Quality of Life 5 dimensions Index (EQ 5D Index) [6 months]
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)
- monthly seizure frequency after 12 months [12 months]
monthly seizure frequency at the follow-up after 12 months
- European Quality of Life 5 dimensions Index (EQ 5D Index) [12 months]
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)
- Seizure freedom [6 months]
percentage of patients without epileptic seizures
- Seizure freedom [12 months]
percentage of patients without epileptic seizures
- interruption of status epilepticus [48 hours]
percentage of patients with interrupted status epilepticus
Secondary Outcome Measures
- Resilience Scale 13 [12 months]
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
- Resilience Scale 13 [24 months]
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
- Multidimensional Fatigue Inventory [12 months]
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
- Multidimensional Fatigue Inventory [24 months]
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
- Beck Depression Inventory II [12 months]
Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
- Beck Depression Inventory II [24 months]
Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
- Berlin Social Support Scales (BSSS) [12 months]
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
- Berlin Social Support Scales (BSSS) [24 months]
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
- World Health Organization Quality of Life-BREF (WHOQOL-BREF) [12 months]
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)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF) [24 months]
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)
- Pittsburgh Sleep Quality Index [12 months]
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
- Pittsburgh Sleep Quality Index [24 months]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Epileptic or psychogenic seizures
Exclusion Criteria:
-
age<18
-
patients who cannot provide informed consent and don't have a legal guardian
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mainz Comprehensive Epilepsy and Sleep Medicine Center | Mainz | Rheinland-Pfalz | Germany | 55131 |
Sponsors and Collaborators
- Johannes Gutenberg University Mainz
Investigators
- Principal Investigator: Yaroslav Winter, MD, MSc, Mainz Comprehensive Epilepsy and Sleep Medicine Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAINZ-EPIREG