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NCT03800992

Bad News- Diagnosis: Epilepsy in Childhood

Data source: WHO (Imported from 03.05.2024)
Changed: May 26, 2019, 2:00 AM
Disease category:

Health conditions (Data source: WHO)

Epilepsy in Children

Interventions (Data source: WHO)

Other: assessment of perception and evaluation of physicians advisory skills per questionnaire

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- newly diagnosed epilepsy (according to International League Against Epilepsy (ILAE)
criteria):

- at least two unprovoked epileptic fits at intervals of at least 24 hours or

- one unprovoked epileptic fit and a recurrence risk of at least 60% or

- epilepsy syndrome

Exclusion Criteria:

- children with intensive care treatment as inpatients

- parents with insufficient German language capabilities

- parents and children with exposure to traumatic events in the past three months that
could probably lead to post traumatic distress (loss of a loved person, severe traffic
accident, raid, violence, sexual assault, war)

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03800992

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03800992
Further information on trial

Date trial registered

Jan 9, 2019

Incorporation of the first participant

Apr 30, 2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

Bad News- Diagnosis: Epilepsy in Childhood

Type of trial (Data source: WHO)

Observational

Phase (Data source: WHO)

Phase 2/Phase 3

Primary end point (Data source: WHO)

perception of physicians advisory skills with respect to actual distress

Secundary end point (Data source: WHO)

Pediatric Quality of Life Inventory (PedsQL 4.0);Child behaviour checklist (CBCL);Questionnaire on the assessment of stress and stress management in Childhood and Adolescence Revision (SSKJ 3-8 R);Change in Pediatric Quality of Life Inventory (Peds-QL);Change in Parenting Stress Index (PSI);Change in Stress Coping Style Questionnaire (SVF) 78/78-S;Change in Adult-Self-Report for Ages 18- 59 (ASR 18-59);Change in Stress and Coping Inventory (SCI);Change in National Comprehensive Cancer Network (NCCN) thermomete

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Contact for general information (Data source: WHO)

Peter Weber, Prof. Dr.;Peter Weber, Prof.Dr.
Universitäts-Kinderspital beider Basel UKBB
+41 61 704 19 08
peter.weber@ukbb.ch

Contact for scientific information (Data source: WHO)

Peter Weber, Prof. Dr.;Peter Weber, Prof.Dr.
Universitäts-Kinderspital beider Basel UKBB
+41 61 704 19 08
peter.weber@ukbb.ch

Further trial identification numbers

Secondary ID (Data source: WHO)

2018-02397
ks18Weber
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