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

NCT03440827 | Unknown

• 2 other identifiers: RC31/17/02102017-A01881-52
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Vascular Malformations

Keywords

low-flow vascular malformations, scale of life's quality

Outcome Measures

Primary Outcomes (1)

• Specific scale of life's quality for slow-flow vascular malformation

  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.

  12 months

Study Arms (1)

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.

Behavioral: Focus Group

Interventions

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.

Child with slow-flow malformation

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (3)

UHBordeaux

Bordeaux, 33076, France

NOT YET RECRUITING

UHChambray

Chambray-lès-Tours, 37170, France

RECRUITING

UHNantes

Nantes, 44093, France

NOT YET RECRUITING

MeSH Terms

Conditions

Vascular Malformations

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Juliette Mazereeuw-Hautier, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliette Mazereeuw-Hautier, MD

CONTACT

5 67 77 81 41; mazereeuw-hautier.j@chu-toulouse.fr

Isabelle OLIVIER, PhD

CONTACT

561777051; olivier.i@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 22, 2018
• Study Start: February 23, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)