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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA, Medical University of Vienna.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520428
First Posted: January 30, 2012
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA, Medical University of Vienna
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 1 Behavioral: Motivational Interviewing, CBT and E-mail support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications. A Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA, Medical University of Vienna:

Primary Outcome Measures:
  • HbA1C [ Time Frame: after 8 months ]
    Metabolic control


Secondary Outcome Measures:
  • 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 ]
    Metabolic control


Estimated Enrollment: 120
Study Start Date: June 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520428


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
National Bank of Austria
Investigators
Principal Investigator: Birgit Rami-Merhar, MD, Uni Prof Medical University of Vienna, Dep. of Pediatrics and Adolescent Medicine
  More Information

Responsible Party: Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA, Univ.Prof.Dr.Med.MBA, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01520428     History of Changes
Other Study ID Numbers: ÖNB13686
First Submitted: January 19, 2012
First Posted: January 30, 2012
Last Update Posted: September 27, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases