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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires and audio-tape interviews
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 focused on measuring adolescence

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged between 12 and 17 inclusive; Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria (IDF & ISPAD, 2011); Length of more than 6 months in the disease; Treatment with insulin for at least 6 months before the educational intervention; Inclusion in a TPE program "Pediatric Diabetes" allowed by the Regional Health Agency Mastery of the French language in written form (elementary level); Mastery of speaking the French language (elementary level); Consent signed by the holders of parental authority and adolescents.

Exclusion Criteria:

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).

Sites / Locations

  • Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

type 1 diabetes adolescents cohort

Arm Description

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

Outcomes

Primary Outcome Measures

self-efficacy (Self-efficacy of Diabetes Management)
a10-items tools self-passation at M0-J2-M1 and M3

Secondary Outcome Measures

Quality of life (KIDSCREEN-27)
a 27-items tools self-passation at M0-M1 and M3
Adherence (Diabetes Self-Management Profile)
a 35-items tools, completed during interview with health professional at M0-J2-M1 and M3
glycated hemoglobin (HbA1c)
Description: biological at M0 and M3
socio-cognitive profile
interviews at M0-M1 and M3

Full Information

First Posted
April 16, 2015
Last Updated
November 15, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02422043
Brief Title
Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program
Official Title
Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 28, 2015 (Actual)
Primary Completion Date
November 15, 2022 (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

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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, coupled with other socio-cognitive factors favoring adherence and a better quality of life for teenager. However, socio-cognitive determinants and mechanisms to achieve this, implemented by adolescents during and after the TPE program, are not sufficiently documented and French assessment tools are missing. Objectives: The main objective of the research is to validate self-efficacy and adherence tools in French for type 1 diabetic teenagers, and secondarily, to describe evolution of a 3-month cohort of type 1 diabetes adolescents who took a TPE program on self-efficacy, quality of life, adherence, glycated hemoglobin (HbA1c) and socio-cognitive factors as Bandura's social cognitive theory and the study of possible links between these endpoints. 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 in one of two study areas. The number of subjects required was estimated to 80 patients. The process of cross-cultural adaptation tools will be through a linguistic and metrological validation. An integrated mixed method was used, consisting of three components: A quantitative before-after study: Collection and analysis of changes over 3 months of self-efficacy, adherence, quality of life and HbA1c (Student t test); A longitudinal qualitative study: interviews with 24 participants M0, M1 and M3 on the socio-cognitive factors according to Bandura (analysis continues theming) An integrative component: exploratory data analysis methods in order to link the evolution of treatment adherence and quality of life, with the evolution of self-efficacy and additional socio-cognitive factors. Outcomes: This pilot research should validate the assessment tools and improve educational sessions for existing and future TPE programs, to type 1 diabetic teenagers to enhance their particular self-efficacy and to promote their independence and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
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
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
type 1 diabetes adolescents cohort
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaires and audio-tape interviews
Intervention Description
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
Primary Outcome Measure Information:
Title
self-efficacy (Self-efficacy of Diabetes Management)
Description
a10-items tools self-passation at M0-J2-M1 and M3
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of life (KIDSCREEN-27)
Description
a 27-items tools self-passation at M0-M1 and M3
Time Frame
3 months
Title
Adherence (Diabetes Self-Management Profile)
Description
a 35-items tools, completed during interview with health professional at M0-J2-M1 and M3
Time Frame
3 months
Title
glycated hemoglobin (HbA1c)
Description
Description: biological at M0 and M3
Time Frame
3 months
Title
socio-cognitive profile
Description
interviews at M0-M1 and M3
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged between 12 and 17 inclusive; Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria (IDF & ISPAD, 2011); Length of more than 6 months in the disease; Treatment with insulin for at least 6 months before the educational intervention; Inclusion in a TPE program "Pediatric Diabetes" allowed by the Regional Health Agency Mastery of the French language in written form (elementary level); Mastery of speaking the French language (elementary level); Consent signed by the holders of parental authority and adolescents. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
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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Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program

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