ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 28 for:    "craniosynostoses" OR "muenke syndrome"

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 (AmAc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02287805
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : August 26, 2016
Sponsor:
Collaborator:
Université de Cergy Pontoise
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment
Craniosynostosis Other: qualitative survey Other: quantitative survey

Detailed 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.


Study Type : Observational
Actual Enrollment : 574 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Craniosynostosis: How to Improve the Diagnosis and Assist Patients and Their Families?
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016


Group/Cohort Intervention/treatment
quantitative survey 1
parents of 300 patients with craniosynostosis diagnostic
Other: quantitative survey
qualitative survey
  • parents of 12 newly diagnosed patients, they will be seen 3 times (after the diagnosis, 3 months after surgery, 1 year after surgery
  • 12 patients aged over 15 years, operated more than 10 years before
Other: qualitative survey
quantitative survey 2
  • 100 parents of patients 1 year after surgery
  • 100 parents of patients, 5 years after the operation
  • 100 patients aged over 15 years and operated over 10 years ago
Other: quantitative survey



Primary Outcome Measures :
  1. measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) [ Time Frame: 5 months ]
    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.


Secondary Outcome Measures :
  1. measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview [ Time Frame: 16 months ]
    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.

  2. measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children with craniosynostosis who are followed by the Reference Center "Dysostoses craniofaciales" and their parents.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287805


Locations
France
Centre de référence des dysostoses craniofaciales, Hôpital Necker Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Université de Cergy Pontoise
Investigators
Study Chair: Séverine Colinet, PhD Cergy University

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02287805     History of Changes
Other Study ID Numbers: URC 1073
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
craniosynostosis
simple form
complex form
diagnostic
announcement
impacts

Additional relevant MeSH terms:
Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities