Description of the Evolution of a Cohort of Adolescents With Type 1 Diabetes Following Their Participation in Therapeutic Education Program Based on Social Cognitive Theory: Socio-cognitive Profile, Physiological Behaviour of Therapeutic Adherence and Quality of Life (ETPACAP)

August 4, 2016 updated by: Assistance Publique Hopitaux De Marseille

Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary management of type 1 diabetes for adolescents, favoring their adherence and improving their quality of life and metabolic control. Six pediatric diabetes teams have engaged in action research to build a regional ETP program based on social cognitive theory of Bandura, assuming that the learning strategies of theory, applied in ETP program, should strengthen self-efficacy of adolescents with type 1 diabetes, which could induce an improvement behaviors adherence, quality of life and physiological profile of participants about 6 months post-inclusion in the program.

Aims: The main objective is to describe the evolution over 6 months of self-efficacy in a cohort of adolescents with type 1 diabetes who followed a therapeutic education program based on social cognitive theory of Bandura in region PACA (ETPACAP program). Secondary objectives are to describe the evolution of 6 months of glycemic control, behavior of adherence, quality of life and other components of social cognitive theory for this population, to explore the effects of socio-cognitive profile on adherence, quality of life and glycemic control among adolescents with type 1 diabetes followed this program.

Method: A prospective multicenter cohort study of adolescents with type 1 diabetes who participated in ETPACAP program, consisting of three components:

  • A quantitative component: collection and analysis of changes over 6 months of self-efficacy, adherence, quality of life and HbA1c levels (ANOVA repeated measures);
  • A qualitative component: interviews with 32 participants at M0, M3 and M6 on the socio-cognitive factors according to Bandura (analysis continues theming);
  • An integrative component, exploring the effects of the components of social cognitive theory on adherence, glycemic control and quality of life of adolescents with type 1 diabetes cohort.

Expected results: This research is expected to bring new knowledge about the ETP programs and the adolescent cohort studied to make an improvement and adjustment of educational sessions relevant to the needs and expectations of this population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

168

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 Contact

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille
        • Contact:

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

11 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 11 and 17 years inclusive;
  • Type 1 diabetes diagnosis confirmed by a doctor according to the diagnostic criteria;
  • More than 6 months in the disease;
  • Treatment with insulin for at least 6 months before the educational intervention;
  • Inclusion in the program ETPACAP;
  • Mastery of the French language written (elementary level)
  • Fluency in speaking the French language (elementary level)
  • Consent signed by the holders of parental authority and adolescents.

Exclusion Criteria:

  • Pregnant women, parturient women or breastfeeding mothers (Article L.1121-5 of the Code of Public Health.)
  • 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 of the Code of Public Health

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: adolescents with type 1 diabetes
adolescents with type 1 diabetes following their participation in therapeutic education program
Other: therapeutic education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy evaluated with the 10 items-SEDM
Time Frame: 6 months
The self-efficacy will be evaluated with the 10 items-SEDM (Iannotti et al., 2006), translated into French by an adaptation process cross-cultural (linguistic validation and metrology)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence will be evaluated using 'the Diabetes Self-Management Profile "tool (DSMP)
Time Frame: 6 months
Adherence will be evaluated using 'the Diabetes Self-Management Profile "tool (DSMP) (Schneider et al., 2007; Iannotti et al, 2006, Harris et al, 2000), translated into french through a process of adaptation-cultural (linguistic and metrological validation)
6 months
Quality of life will be assessed using the KIDSCREEN-27
Time Frame: 6 months
The quality of life will be assessed using the KIDSCREEN-27 (v 8-18 years) (Robitail et al., 2007). The KIDSCREEN is a self-administered generic questionnaire developed and validated as part of a European research project with children and adolescents (Kidscreen Group, 2006)
6 months
Glycemic control: glycated hemoglobin (HbA1c)
Time Frame: 6 months
The glycated hemoglobin (HbA1c) in rising every medical visit (ISPAD, 2011)
6 months
Outcome expectations, socio-structural factors and personal goals
Time Frame: 6 months
An individual semi-structured interview and audio-recorded will be led by a social health psychologist. The duration will not exceed 45 minutes. Identification of the participant in the qualitative component will link data from the interview with the collected quantitative data.
6 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

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM15_0120

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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