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
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.
|Condition or disease||Intervention/treatment||Phase|
|Vascular Malformations||Behavioral: Focus Group||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Validation of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations Aged 11 to 15 Years-old.|
|Actual Study Start Date :||February 23, 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
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.
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.
- 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.
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): NCT03440827
|Contact: Juliette Mazereeuw-Hautier, MD||5 67 77 81 41 ext email@example.com|
|Contact: Isabelle OLIVIER, PhD||561777051 ext +firstname.lastname@example.org|
|UHBordeaux||Not yet recruiting|
|Bordeaux, France, 33076|
|Contact: Christine Leauté-Labrèze, MD 556795642 ext +33 email@example.com|
|Chambray-lès-Tours, France, 37170|
|Contact: Annabel Maruani-Raphael, MD 247474625 ext +33 firstname.lastname@example.org|
|UHNantes||Not yet recruiting|
|Nantes, France, 44093|
|Contact: Sébastien Barbarot, MD 240084086 ext +33 email@example.com|
|Principal Investigator:||Juliette Mazereeuw-Hautier, MD||University Hospital, Toulouse|