Clinical trial NCT02859779: Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions
Official title: Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions: A Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes in Adolescence
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Background: In type 1 diabetes, adolescence is often associated with deterioration in glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to insulin. Therapeutic patient education (TPE) is the key to successful management of the disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the Mediterranean region in France, and the care teams implementing them wish to promote joint reflection with sick teenagers and families to identify needs and expectations of everyone on priority skills to develop, to promote better management of the disease and improved quality of life.

Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions, to promote self-management of their disease and their treatment.

Method: Four audio-recorded focus groups will be organized in all 10 clinical settings (adolescents, parents and health professionals). Thematic analysis will be carried out from the transcript of the focus groups.

Expected results: The results will allow a joint reflection involving the participation of young patients, families, health professionals and the research team to build and implement new educational sessions that meet the identified needs. This action resulting from the research is expected to pool resources in different health facilities providing therapeutic education programs and to harmonize practices.


Eligibility criteria: Inclusion Criteria:

* Aged between 11 and 16 years inclusive
* Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria
* Monitoring in the institutions participating in the research
* Speaking the French language (elementary level)
* Consent signed by the holders of the exercise of parental authority and the participant

Exclusion Criteria:

* Pregnant women, parturient women or breastfeeding mothers
* Persons deprived of liberty by a judicial or administrative decision
* Those hospitalized without consent under articles L. 3212-1 and L. 3213-1 that do not fall under the provisions of Article L. 1121-8
* Persons admitted in a health or social institution for purposes other than research (art. L.1121-6 health public code)

Primary outcomes:
measure: Needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions
timeFrame: one day
Secondary outcomes:
measure: Needs and expectations of parents of adolescents with type 1 diabetes for skills to be developed during the educational sessions
timeFrame: one day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Study officials:
References: