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

NCT ID: NCT01520428

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Motivational Interviewing, CBT and E-mail support

Group Type ACTIVE_COMPARATOR

Motivational Interviewing, CBT and E-mail support

Intervention Type BEHAVIORAL

Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support

E-Mail-support

Group Type ACTIVE_COMPARATOR

Motivational Interviewing, CBT and E-mail support

Intervention Type BEHAVIORAL

Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support

Interventions

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Motivational Interviewing, CBT and E-mail support

Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support

Intervention Type BEHAVIORAL

Other Intervention Names

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Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Bank of Austria

OTHER_GOV

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA

Univ.Prof.Dr.Med.MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgit Rami-Merhar, MD, Uni Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Dep. of Pediatrics and Adolescent Medicine

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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ÖNB13686

Identifier Type: -

Identifier Source: org_study_id