Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program

NCT02422043 | Completed

• 1 other identifier: 2014-28
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to make the teenager to self manage their disease and its treatment. Based on social cognitive theory Bandura, the effects of educational activities for TVE should lead to the strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence of teenager and a better quality of life. However, socio-cognitive determinants and mechanisms to achieve this, implemented by adolescents during and after the ETP program, are not sufficiently documented.

Conditions

Type 1 Diabetes

Keywords

adolescence

Outcome Measures

Primary Outcomes (1)

• self-efficacy (Self-efficacy of Diabetes Management)

  a10-items tools self-passation at M0-J2-M1 and M3

  3 months

Secondary Outcomes (4)

• Quality of life (KIDSCREEN-27)

  3 months

• Adherence (Diabetes Self-Management Profile)

  3 months

• glycated hemoglobin (HbA1c)

  3 months

• socio-cognitive profile

  3 months

Study Arms (1)

type 1 diabetes adolescents cohort

EXPERIMENTAL

The participants of the prospective cohort of adolescents will be 12 to 17 years of age, type 1 diabetics with insulin, included in TPE program

Other: Questionnaires and audio-tape interviews

Interventions

Questionnaires and audio-tape interviews OTHER

therapeutic patient education programs (TPE) to type 1 diabetic adolescents are designed to make the teenager to self manage their disease and their treatment. Based on Bandura's social cognitive theory, effects of educational activities for TPE should lead to the strengthening of self-efficacy

type 1 diabetes adolescents cohort

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Adolescents considered treatment failure, addressed to the SSR for intensive TPE inpatient program over a period of more than a month; Pregnant women, breast-feeding mothers (art L.1121-5 CSP). Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research (art. L.1121-6 CSP) Major persons under a legal protection measure or unable to consent (Article L.1121-8 CSP).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 21, 2015
• Study Start: January 28, 2015
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

FR (1)