Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMotivational Interviewing, CBT and E-mail support
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support
Sponsors
National Bank of Austria
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus, type1 * HbA1c\>8 * 1 year of diagnosis * Access to Internet available
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | after 8 months | Metabolic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictors of positive effects on glycaemic control | after 6 months and after 12 months | — |
| Motivational changes | after 6 months and 12 months | — |
| HbA1c | after 12 months | Metabolic control |
Countries
Austria
Outcome results
None listed