Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment motivational interviewing, cbt and e-mail support
Sponsor Medical University of Vienna
Collaborator National Bank of Austria
Start date June 2010
End date January 2013
Trial size 120 participants
Trial identifier NCT01520428, ÖNB13686

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
motivational interviewing, cbt and e-mail support Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support
(Active Comparator)
motivational interviewing, cbt and e-mail support Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support

Primary Outcomes

Measure
HbA1C
time frame: after 8 months

Secondary Outcomes

Measure
Predictors of positive effects on glycaemic control
time frame: after 6 months and after 12 months
Motivational changes
time frame: after 6 months and 12 months
HbA1c
time frame: after 12 months

Eligibility Criteria

Male or female participants from 13 years up to 20 years old.

Inclusion Criteria: - Diabetes mellitus, type1 - HbA1c>8 - 1 year of diagnosis - Access to Internet available Exclusion Criteria: - N/A

Additional Information

Official title Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications. A Multicenter Randomized Controlled Trial
Principal investigator Birgit Rami-Merhar, MD, Uni Prof
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Medical University of Vienna.