Type 1 Diabetes in Adolescence Clinical Trial
— BADETOfficial title:
Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions: A Qualitative Study
| Verified date | November 2022 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 15, 2022 |
| Est. primary completion date | April 12, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 11 Years to 16 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital de la Timone Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions | An interview guide was developed from the regulatory framework of therapeutic education in France, the theoretical framework of psychosocial skills in social psychology of health and from a previous experiment in the UK with diabetic children and their parents, to develop communication skills of health professionals (Hawthorne et al., 2011) | one day | |
| Secondary | Needs and expectations of parents of adolescents with type 1 diabetes for skills to be developed during the educational sessions | An interview guide was developed from the regulatory framework of therapeutic education in France, the theoretical framework of psychosocial skills in social psychology of health and from a previous experiment in the UK with diabetic children and their parents, to develop communication skills of health professionals (Hawthorne et al., 2011) | one day |