Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions

NCT ID: NCT02859779

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-04
• Study Completion Date: 2022-11-15

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.

Conditions

Type 1 Diabetes in Adolescence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

mediterranean adolescents with type 1 diabetes

Group Type: OTHER

education programs

Intervention Type: BEHAVIORAL

Four audio-recorded discussion groups will be organized in each of the 10 clinical settings

Interventions

education programs

Four audio-recorded discussion groups will be organized in each of the 10 clinical settings

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2015-36

Identifier Type: -

Identifier Source: org_study_id