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NCT03800992

Bad News- Diagnosis: Epilepsy in Childhood

Datenbasis: WHO (Import vom 22.09.2019)
Geändert: 26.05.2019
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Epilepsy in Children

Interventions (Datenquelle: WHO)

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

Inclusion/Exclusion Criteria (Datenquelle: 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)

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT03800992

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03800992

Weitere Informationen zur Studie

Registrationsdatum der Studie

09.01.2019

Einschluss der ersten teilnehmenden Person

30.04.2019

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

Bad News- Diagnosis: Epilepsy in Childhood

Studientyp (Datenquelle: WHO)

Observational

Phase (Datenquelle: WHO)

Phase 2/Phase 3

Primäre Endpunkte (Datenquelle: WHO)

perception of physicians advisory skills with respect to actual distress

Sekundäre Endpunkte (Datenquelle: 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) thermometer

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

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

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

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

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

University Hospital, Basel, Switzerland

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

2018-02397; ks18Weber