Qualitative and Quantitative Study Which Aims to Determine the Specifics of the Announcement for the Diagnosis of Patients With Craniosynostosis and Their Parents to Better Support Them in Their Care

Craniosynostosis Clinical Trial

— AmAc  

Official title:

Craniosynostosis: How to Improve the Diagnosis and Assist Patients and Their Families?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287805
• Other study ID #: URC 1073
• Status: Completed
• Phase: N/A
• First received: October 10, 2014
• Last updated: August 25, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

The purposes of this study are:

• to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation

• to compare the announcement process concerning "simple" and "complex" forms.

• to identify the intra-family issues at the announcement of a genetic mutation.

• to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.

Description:

The supported hypothesis is that the diagnosis of craniosynostosis disturbs the initial family pattern. The different forms of the disease will have different repercussions on intra-family relationships.

The quality of the announcement done by the doctor influences the way how the subjects (parents and patients themselves) appropriate and incorporate it at short, medium and long term.

This research will contribute to the knowledge of this rare disease by different scientific communities: social sciences, medicine and neuropsychology. The originality of this research lies in interdisciplinary teams involved and the cross looks between professional and associative fields.

To better understand the impact of congenital malformations and specifically those related to craniosynostosis, the experiences of children and their families at short, medium and long term, the research will take place in the center of reference "Dysostoses craniofacial", Pediatric Neurosurgery Service at the Necker Hospital in Paris.

Prior to fieldwork, a thorough literature search will be conducted on issues related to our subject: the announcement, psychological, identity, family and social impacts, as well as the specifics of the disease and its manifestations.

The fieldwork will be included in a longitudinal approach which will be located at the intersection of quantitative and qualitative methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria :

Group 1 :

Parents of operated children with a clinical diagnosis of craniosynostosis

Group 2 :

• Parents of newly diagnosed children for a craniosynostosis who will be operated

• Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Group 3 :

• Parents of newly diagnosed children for a craniosynostosis who will be operated

• Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Exclusion Criteria:

• nothing to declare

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniosynostoses
• Craniosynostosis

Intervention

Other:
• qualitative survey

• quantitative survey

Locations

Country	Name	City	State
France	Centre de référence des dysostoses craniofaciales, Hôpital Necker Enfants Malades	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Université de Cergy Pontoise

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)	Analysis of the questionnaires will permit us to learn more about the conditions and experiences of the announcement concerning different profiles families whose experience has been received differently depending on the type of craniosynostosis (simple or complex), the medical history or sociodemographic characteristics.	5 months	No
Secondary	measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview	In a longitudinal perspective, we will develop interview guides. For conducting interviews, we will use the life story method. The interest of the life story is that it provides a method to study the modes of appropriation of the announcement and the way in which subjects incorporate it into their life history.	16 months	No
Secondary	measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)	From the results of all the interviews (from qualitative survey) and the analysis of questionnaires from the quantitative survey 1, we will develop questionnaires for themes and issues that have emerged from those analyses (accompanying the announcement of genetic mutation in the family, aesthetics, education ...). It will then develop targeted questionnaires, based on the analysis of interviews and questionnaires from the quantitative survey. The goal will be a deepening of themes.	6 months	No