Diabetes Mellitus, Type 1NCT01520428
Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications
A study testing Motivational Interviewing, CBT and E-mail support in people with Diabetes Mellitus, Type 1, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Motivational Interviewing, CBT and E-mail support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diabetes mellitus, type1
- HbA1c>8
- 1 year of diagnosis
- Access to Internet available
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications. A Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Motivational Interviewing, CBT and E-mail support
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing, CBT and E-mail supportBehavioural
Also called Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents
Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing, CBT and E-mail support | Active comparator | Not described Receives: Behavioral: Motivational Interviewing, CBT and E-mail support |
| E-Mail-support | Active comparator | Not described Receives: Behavioral: Motivational Interviewing, CBT and E-mail support |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Metabolic control
Measured: after 8 months
Secondary outcomes (3)
Predictors of positive effects on glycaemic control
Measured: after 6 months and after 12 months
Motivational changes
Measured: after 6 months and 12 months
HbA1c
Metabolic control
Measured: after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJun 2010
- Primary completionJan 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- National Bank of Austria
- Responsible party
- Principal investigator, Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA, Medical University of Vienna
- Investigators
- Birgit Rami-Merhar, MD, Uni Prof, Principal investigator, Medical University of Vienna, Dep. of Pediatrics and Adolescent Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520428
- Sponsor's protocol ID
- ÖNB13686
- Status last verified
- Sep 2012
- First submitted
- 19 Jan 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications. A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01520428
- Acronym / sponsor ID
- ÖNB13686
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- National Bank of Austria
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diabetes mellitus, type1
- HbA1c>8
- 1 year of diagnosis
- Access to Internet available
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing, CBT and E-mail supportAlso: Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescentsMotivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support | Behavioural | E-Mail-support, Motivational Interviewing, CBT and E-mail support |
Primary outcome
HbA1C
Time frame: after 8 months
Metabolic control
3 secondary outcomes
Predictors of positive effects on glycaemic control
Time frame: after 6 months and after 12 months
Motivational changes
Time frame: after 6 months and 12 months
HbA1c
Time frame: after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Rami-Merhar, MD, Uni Prof principal investigator
Medical University of Vienna, Dep. of Pediatrics and Adolescent Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing, CBT and E-mail support in people with Diabetes Mellitus, Type 1, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: after 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.