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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01520428
First received: January 19, 2012
Last updated: September 26, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Medical University of Vienna:

Primary Outcome Measures:
  • HbA1C [ Time Frame: after 8 months ] [ Designated as safety issue: No ]
    Metabolic control


Secondary Outcome Measures:
  • Predictors of positive effects on glycaemic control [ Time Frame: after 6 months and after 12 months ] [ Designated as safety issue: No ]
  • Motivational changes [ Time Frame: after 6 months and 12 months ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 19, 2012
Last Updated: September 26, 2012
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on July 29, 2014