Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02422043 |
| Other study ID # |
2014-28 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 28, 2015 |
| Est. completion date |
November 15, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
