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Trial record 2 of 2791 for:    Type 1 Diabetes

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

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ClinicalTrials.gov Identifier: NCT02859779
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Type 1 Diabetes in Adolescence Behavioral: education programs

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions: A Qualitative Study
Actual Study Start Date : November 25, 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
mediterranean adolescents with type 1 diabetes Behavioral: education programs


Outcome Measures

Primary Outcome Measures :
  1. Needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions [ Time Frame: one day ]
    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 :
  1. Needs and expectations of parents of adolescents with type 1 diabetes for skills to be developed during the educational sessions [ Time Frame: one day ]
    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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859779


Locations
France
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Marie-Claude SIMEONI-LAGOUANELLE    04 91 38 30 00    marie.lagouanelle@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02859779     History of Changes
Other Study ID Numbers: 2015-36
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases