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

November 15, 2022 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: type 1 diabetes adolescents cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-efficacy (Self-efficacy of Diabetes Management)
Time Frame: 3 months
a10-items tools self-passation at M0-J2-M1 and M3
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (KIDSCREEN-27)
Time Frame: 3 months
a 27-items tools self-passation at M0-M1 and M3
3 months
Adherence (Diabetes Self-Management Profile)
Time Frame: 3 months
a 35-items tools, completed during interview with health professional at M0-J2-M1 and M3
3 months
glycated hemoglobin (HbA1c)
Time Frame: 3 months
Description: biological at M0 and M3
3 months
socio-cognitive profile
Time Frame: 3 months
interviews at M0-M1 and M3
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2015

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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