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

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Medical University of Vienna

Status

Unknown

Conditions

Diabetes Mellitus, Type 1

Treatments

Behavioral: Motivational Interviewing, CBT and E-mail support

Study type

Interventional

Funder types

Other

Identifiers

NCT01520428
ÖNB13686

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

13 to 20 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • N/A

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Motivational Interviewing, CBT and E-mail support
Active Comparator group
Treatment:
Behavioral: Motivational Interviewing, CBT and E-mail support
E-Mail-support
Active Comparator group
Treatment:
Behavioral: Motivational Interviewing, CBT and E-mail support

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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