NCT02287805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
574

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

October 10, 2014

Last Update Submit

August 25, 2016

Conditions

Craniosynostosis

Keywords

craniosynostosissimple formcomplex formdiagnosticannouncementimpacts

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview

    16 months

  • measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)

    6 months

Study Arms (3)

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

Interventions

qualitative surveyOTHER
qualitative survey
quantitative surveyOTHER
quantitative survey 1quantitative survey 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

children with craniosynostosis who are followed by the Reference Center "Dysostoses craniofaciales" and their parents.

You may qualify if:

  • 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

You may not qualify if:

  • nothing to declare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de référence des dysostoses craniofaciales, Hôpital Necker Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

CraniosynostosesDisease

Condition Hierarchy (Ancestors)

SynostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Séverine Colinet, PhD

    Cergy University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2014

First Posted

November 11, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

FR(1)