NCT01520428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

2.6 years

First QC Date

January 19, 2012

Last Update Submit

September 26, 2012

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    Metabolic control

    after 8 months

Secondary Outcomes (3)

  • Predictors of positive effects on glycaemic control

    after 6 months and after 12 months

  • Motivational changes

    after 6 months and 12 months

  • HbA1c

    after 12 months

Study Arms (2)

Motivational Interviewing, CBT and E-mail support

ACTIVE COMPARATOR
Behavioral: Motivational Interviewing, CBT and E-mail support

E-Mail-support

ACTIVE COMPARATOR
Behavioral: Motivational Interviewing, CBT and E-mail support

Interventions

Motivational Interviewing, CBT and E-mail supportBEHAVIORAL

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

Also known as: Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents
E-Mail-supportMotivational Interviewing, CBT and E-mail support

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Motivational InterviewingCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesBehavior TherapyPsychotherapy

Study Officials

  • Birgit Rami-Merhar, MD, Uni Prof

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof.Dr.Med.MBA

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 30, 2012

Study Start

June 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2014

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

AU(1)