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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01881-52 | Other Identifier | UHToulouse |
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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.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child with slow-flow malformation | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focus Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Specific scale of life's quality for slow-flow vascular malformation | Specific scale of life's quality for slow-flow vascular malformation.
| 12 months |
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Inclusion Criteria:
Phase 1:
Phase 2 :
Exclusion criteria :
For both phases: Pregnant or lactating women or girls,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliette Mazereeuw-Hautier, MD | Contact | 5 67 77 81 41 | 33 | mazereeuw-hautier.j@chu-toulouse.fr |
| Isabelle OLIVIER, PhD | Contact | 561777051 | +33 | olivier.i@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Juliette Mazereeuw-Hautier, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHBordeaux | Not yet recruiting | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| UHChambray | Recruiting | Chambray-lès-Tours | 37170 | France |
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| UHNantes | Not yet recruiting | Nantes | 44093 | France |
|
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |