Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications
Primary Purpose
Diabetes Mellitus, Type 1
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Motivational Interviewing, CBT and E-mail support
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Diabetes mellitus, type1
- HbA1c>8
- 1 year of diagnosis
- Access to Internet available
Exclusion Criteria:
- N/A
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Motivational Interviewing, CBT and E-mail support
E-Mail-support
Arm Description
Outcomes
Primary Outcome Measures
HbA1C
Metabolic control
Secondary Outcome Measures
Predictors of positive effects on glycaemic control
Motivational changes
HbA1c
Metabolic control
Full Information
NCT ID
NCT01520428
First Posted
January 19, 2012
Last Updated
September 26, 2012
Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
1. Study Identification
Unique Protocol Identification Number
NCT01520428
Brief Title
Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications
Official Title
Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications. A Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing, CBT and E-mail support
Arm Type
Active Comparator
Arm Title
E-Mail-support
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing, CBT and E-mail support
Other Intervention Name(s)
Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents
Intervention Description
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support
Primary Outcome Measure Information:
Title
HbA1C
Description
Metabolic control
Time Frame
after 8 months
Secondary Outcome Measure Information:
Title
Predictors of positive effects on glycaemic control
Time Frame
after 6 months and after 12 months
Title
Motivational changes
Time Frame
after 6 months and 12 months
Title
HbA1c
Description
Metabolic control
Time Frame
after 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes mellitus, type1
HbA1c>8
1 year of diagnosis
Access to Internet available
Exclusion Criteria:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Rami-Merhar, MD, Uni Prof
Organizational Affiliation
Medical University of Vienna, Dep. of Pediatrics and Adolescent Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications
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