Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications. A Multicenter Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of diabetes management training combined with the method of Motivational Interviewing with elements of Cognitive Behaviour Therapy and E-mail support in the treatment of type 1 diabetes in adolescents (age range 13-20 years) compared to a control group. The investigators assess motivational changes and effects on metabolic control.
Diabetes mellitus type1 requires lifelong insulin substitution, aiming at near normal
glycaemia. Insufficient metabolic control (HbA1c > 8 %) leads to micro and macro- vascular
complications. Especially in adolescence a lack of compliance leads to deteriorated
metabolic control. Motivational factors play a pivotal role in this age-group, however they
have neither been studied so far nor considered in interventions with diabetes patients.
Therefore, the aim of this study is to evaluate in a multi-centred randomized controlled
trial the effectiveness of diabetes management training with the method of Motivational
Interviewing with elements of Cognitive Behaviour Therapy and E-mail support.
Sixty adolescents within the age group of 13-20 years and HbA1c levels > 8 % will - after a
refresher course in diabetes education - be involved to 2-weekly individual interventions
sessions including motivational interviewing and CBT-modules with a psychologist and weekly
e-mail support for a period of six month in order to improve HbA1c levels, self- efficacy in
diabetes management and general quality of life.
As control group sixty adolescents within the age group of 13-20 years and HbA1c levels > 8
will - after a refresher course in diabetes education - get treatment as usual, including
routine medical support visits, unspecific psychological consultations and unspecific e-mail
support to match with the intervention group for time bonus.
We assess motivational changes and effects on metabolic control (HbA1c) and define the
predictors of positive effects on glycaemic control.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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