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

NCT02859818 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2016-08-09

No results posted yet for this study

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.

Conditions

  • Type 1 Pediatric Diabetes

Interventions

OTHER

therapeutic education program

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Urielle DESALBRES · Assistance Publique Hôpitaux de Marseille

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-12-31
Completion
2020-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859818 on ClinicalTrials.gov