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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01520428
Other study ID # ÖNB13686
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 19, 2012
Last updated September 26, 2012
Start date June 2010
Est. completion date January 2014

Study information

Verified date September 2012
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date January 2014
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 20 Years
Eligibility Inclusion Criteria:

- Diabetes mellitus, type1

- HbA1c>8

- 1 year of diagnosis

- Access to Internet available

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing, CBT and E-mail support
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Vienna National Bank of Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1C Metabolic control after 8 months No
Secondary Predictors of positive effects on glycaemic control after 6 months and after 12 months No
Secondary Motivational changes after 6 months and 12 months No
Secondary HbA1c Metabolic control after 12 months No
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