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Development of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations (MVFL)

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ClinicalTrials.gov Identifier: NCT03440827
Recruitment Status : Unknown
Verified March 2018 by University Hospital, Toulouse.
Recruitment status was:  Recruiting
First Posted : February 22, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date March 5, 2018
Actual Study Start Date  ICMJE February 23, 2018
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
Specific scale of life's quality for slow-flow vascular malformation [ Time Frame: 12 months ]
Specific scale of life's quality for slow-flow vascular malformation.
  • the preliminary version of which is created by transforming the qualitative categories resulting from the qualitative analysis of the verbatim into an exhaustive list of thematic items which will then be selected and sorted by the experts
  • and whose final version is obtained by the statistical validation analysis aimed at structural validity and unidimensionality and convergent and discriminant validity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations
Official Title  ICMJE Development and Validation of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations Aged 11 to 15 Years-old.
Brief Summary

The low-flow malformations include venous and lymphatic malformations. The malformation often affects the skin and can extend deep to the muscles and bone, as well as to deep organs. Children with low-flow vascular malformation and their family have difficulty living with their illness and have an impact on their life quality.

In this context, the aim of the study is to develope life quality test for the children between 11 to 15 years old.

Detailed Description

The low-flow vascular malformations include venous and lymphatic malformations. These malformations are made of dilated dysplastic vessels in which the circulation is lowed down, which can lead to phenomena of thrombosis, hemorrhage, with sometimes a repercussion on the general coagulation. The malformation often affects the skin and can extend deep to the muscles and bone, as well as to deep organs. It presents by swelling sometimes voluminous and often painful. Children with low-flow malformations and their families have difficulty living with their illness and have an impact on their quality of life (QOL).

These difficulties seem relative to :

  • the lack of knowledge of the disease by doctors and the general public - medical difficulties directly related to the disease and its evolution: pain, deformation, biological anomaly, chronicity, lack of effective treatment
  • psychological difficulties related to the visible and unesthetic appearance of the lesions
  • excluding certain social activities The difficulties experienced by patients with slow-flow malformations and their family, as well as the impact on their QOL, have never been studied. Although QOL appears to be the best reflection of the severity of a chronic condition, there is no QOL questionnaire that is appropriate for the slow-flow malformations of the child or adult.

The aim of the study is to develope a specific life quality test for children between 11 to 15 years old.

These data will be used in a second time to build and validate a scale of quality of life specific slow-flow malformations of the child aged 11 to 15 years old. The study is build in 3 parts:

Focus group: collect the dimension of the lived experience and the perceptions of the children with slow-flow malformations as well as their needs and their expectations

Validation of the life quality test: the data obtained during focus group will be used to develop the scale of life quality specific to the child aged 11 to 15 years suffering to low-flow malformations. In a second time to validate the scale, this life quality test will be send to patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Vascular Malformations
Intervention  ICMJE Behavioral: Focus Group
First (phase 1), collect experiences, perceptions, difficulties, needs and expectations of patients with slow-flow malformations (for the age group of 11 to 15 years-old), carried out with 3 categories of participants and then (phase 2) development and validation of the specific scale of life's quality of slow-flow vascular malformation in children aged 11 to 15 years-old.
Study Arms  ICMJE Child with slow-flow malformation

Phase 1: Collect of experiences, perceptions, difficulties, needs and expectations of patients with slow-flow vascular malformation (for the age group of 11 to 15 years-old) using the focus group method.

Phase 2 : Administration of the scale of life's quality for validation.

Intervention: Behavioral: Focus Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 14, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Phase 1:

  • Patient with slow-flow vascular malformation, regardless of clinical form, severity (clinical and imaging diagnosis), aged 11 to 15 years-old.
  • Patient with slow-flow vascular malformation, whatever its clinical form, its severity (clinical and imaging diagnosis), aged over 15 years-old.
  • Parents of a patient with slow-flow vascular malformation, regardless of clinical form, severity (clinical and imaging diagnosis), aged 11 to 15 years-old inclusive
  • Patient affiliated to a social security scheme
  • Patient having given his consent or for the minor whose legal representative has given written informed consent.

Phase 2 :

  • Patient with slow-flow vascular malformation, regardless of clinical form, severity (clinical and imaging diagnosis), 11 to 15 years-old of age included.
  • Patient affiliated to a social security scheme
  • Patient having given his consent or for the minor whose legal representative has given his informed consent

Exclusion criteria :

For both phases: Pregnant or lactating women or girls,

  • Vulnerable persons,
  • Majors subject to a legal protection measure or unable to express their consent Phase 1: Patient or parent who does not speak the French language and therefore are unable to express themselves in the focus groups.
  • Patient under 11 years-old; Phase 2 : Patient who does not speak French and is therefore unable to complete quality of life questionnaires
  • Patient under 11 or over 15 years-old.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03440827
Other Study ID Numbers  ICMJE RC31/17/0210
2017-A01881-52 ( Other Identifier: UHToulouse )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juliette Mazereeuw-Hautier, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP