Clinical trial NCT02859818: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Pediatric Diabetes
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 168
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-efficacy evaluated with the 10 items-SEDM
timeFrame: 6 months
Secondary outcomes:
measure: Adherence will be evaluated using 'the Diabetes Self-Management Profile "tool (DSMP)
timeFrame: 6 months
measure: Quality of life will be assessed using the KIDSCREEN-27
timeFrame: 6 months
measure: Glycemic control: glycated hemoglobin (HbA1c)
timeFrame: 6 months
measure: Outcome expectations, socio-structural factors and personal goals
timeFrame: 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References: