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

Not Applicable

• Conditions: Type 1 Pediatric Diabetes
• Interventions: Other: therapeutic education program

• Registration Number: NCT02859818
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-04
• Last Update Submitted: 2016-08-04
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09
• Study Start: 2016-12
• Primary Completion: 2019-12
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adolescents with type 1 diabetes	therapeutic education program	adolescents with type 1 diabetes following their participation in therapeutic education program

Primary Outcome Measures

Name	Time	Method
Self-efficacy evaluated with the 10 items-SEDM	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)

Secondary Outcome Measures

Name	Time	Method
Quality of life will be assessed using the KIDSCREEN-27	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)
Glycemic control: glycated hemoglobin (HbA1c)	6 months	The glycated hemoglobin (HbA1c) in rising every medical visit (ISPAD, 2011)
Adherence will be evaluated using 'the Diabetes Self-Management Profile "tool (DSMP)	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)
Outcome expectations, socio-structural factors and personal goals	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.

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France