Clinical trial NCT02422043: Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program
Official title: Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: adolescence
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: self-efficacy (Self-efficacy of Diabetes Management)
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life (KIDSCREEN-27)
timeFrame: 3 months
measure: Adherence (Diabetes Self-Management Profile)
timeFrame: 3 months
measure: glycated hemoglobin (HbA1c)
timeFrame: 3 months
measure: socio-cognitive profile
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References: