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

Primary Purpose

Type 1 Diabetes in Adolescence

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
education programs
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes in Adolescence

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

mediterranean adolescents with type 1 diabetes

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
August 1, 2016
Last Updated
November 15, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02859779
Brief Title
Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions
Acronym
BADET
Official Title
Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions: A Qualitative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 4, 2017 (Actual)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes in Adolescence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mediterranean adolescents with type 1 diabetes
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
education programs
Intervention Description
Four audio-recorded discussion groups will be organized in each of the 10 clinical settings
Primary Outcome Measure Information:
Title
Needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions
Description
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)
Time Frame
one day
Secondary Outcome Measure Information:
Title
Needs and expectations of parents of adolescents with type 1 diabetes for skills to be developed during the educational sessions
Description
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)
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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

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