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

September 26, 2012 updated by: Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA, Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Motivational Interviewing, CBT and E-mail support
Behavioral: Motivational Interviewing, CBT and E-mail support
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support
Other Names:
  • Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents
ACTIVE_COMPARATOR: E-Mail-support
Behavioral: Motivational Interviewing, CBT and E-mail support
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support
Other Names:
  • Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C
Time Frame: after 8 months
Metabolic control
after 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of positive effects on glycaemic control
Time Frame: after 6 months and after 12 months
after 6 months and after 12 months
Motivational changes
Time Frame: after 6 months and 12 months
after 6 months and 12 months
HbA1c
Time Frame: after 12 months
Metabolic control
after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

National Bank of Austria

Investigators

  • Principal Investigator: Birgit Rami-Merhar, MD, Uni Prof, Medical University of Vienna, Dep. of Pediatrics and Adolescent Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2013

Study Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (ESTIMATE)

January 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2012

Last Update Submitted That Met QC Criteria

September 26, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ÖNB13686

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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