Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications

Not Applicable

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Motivational Interviewing, CBT and E-mail support

• Registration Number: NCT01520428
• Lead Sponsor: Medical University of Vienna

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-30
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27
• Primary Completion: 2013-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Diabetes mellitus, type1
• HbA1c>8
• 1 year of diagnosis
• Access to Internet available

Read More

Exclusion Criteria

• N/A

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational Interviewing, CBT and E-mail support	Motivational Interviewing, CBT and E-mail support	-
E-Mail-support	Motivational Interviewing, CBT and E-mail support	-

Primary Outcome Measures

Name	Time	Method
HbA1C	after 8 months	Metabolic control

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria