Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/01/2010
Date assigned
08/03/2010
Last edited
15/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Gitte Reventlov Husted

ORCID ID

Contact details

Hillerød Hospital
Dyrehavevej 15B
Hillerød
3400
Denmark
+45 2026 4339
gihu@hih.regionh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Life skills for adolescents with type 1 diabetes and their parents: an interventional study with a concurrent mixed methods design

Acronym

Study hypothesis

Guided self-determination can be developed and implemented for adolescents and their parents in Paediatric Outpatient Clinics and have a positive impact on adolescents' development of diabetes self-management to specific diabetes-related problems including achieving better glycaemic control.

Ethics approval

The study has been considered by the Danish Ethical Committee and they concluded that as this trial does not involve any interventions further than a routine HbA1c test, formal ethics approval was not required. This project is registered at the the Danish Data Tilsyn (ref: 2008-41-2322).

Study design

Interventional randomised controlled trial with a concurrent mixed methods design (quantitative and qualitative)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type I diabetes

Intervention

Participants are randomised to an intervention group (n = 34) or a control group (n = 34). Adolescents and parents in the intervention group receive guided self-determination at the Paediatric Outpatient Clinic appointments using reflection sheets as a starting point for the conversations with doctors, nurses and dietricians. Participants in the control group carry out the appointments as usual, when attending the Paediatric Outpatient Clinic.

The paticipants are seen 8 times a year irrespective of whether they are in the intervention group or in the control group. The first four visist are planned to be every month and thereafter every second month for both groups.

The paticipants in the intervention group are seen an hour at every visit. Futhermore the parents are offered to be seen to times alone during the project year beside the visits they participate in together with their adolescents.

The participants in the control group are seen as normal routine visits from half an hour to 45 minutes. Parents are offered to participate as they are used to do.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at baseline and every third month until the end of the study:
1. HbA1c
2. Perception of Parents Scale (POPS)
3. Health Care Climate Questionaire (HCCQ)
4. Problem Areas in Diabetes (PAID)
5. Perception of Competence (PCD)
6. World Health Organization Wellbeing Index (WHO5 - well-being)
7. Self monitoring blood glucose (SMBG) per week and cancellations or failure to show up are registered

Secondary outcome measures

Measured at baseline, 6 months and 12 months:
Regarding the qualitative part, adolescents and their parents from the intervention group are being followed through the process. Consultations at the Paediatric Outpatient Clinics are being taped. At the end of the study adolescents, parents and health professionals are interviewed. Constant comparative analysis as recommended by Grounded Theory is used.

Overall trial start date

09/09/2009

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adolescents between the ages 13 - 18 years, either sex, and their parents
2. A diagnosis of type 1 diabetes for at least 1 year
3. Poorly regulated, defined by a HbA1c above or equal to 8.0%
4. Participants must speak, read, write and understand Danish

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

68 adolescents and (n) parents

Participant exclusion criteria

1. Adolescents with severe illness, mental problems, in current psychological or psychiatric treatment
2. Adolescents who do not want to participate and do not sign a consent form
3. Parents with severe illness, mental problems, in current psychological or psychiatric treatment
4. Parents who do not want to participate and do not sign a consent form
5. Unable to speak, read, write and understand Danish

Recruitment start date

09/09/2009

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Denmark

Trial participating centre

Hillerød Hospital
Hillerød
3400
Denmark

Sponsor information

Organisation

Hillerød Hospital (Denmark)

Sponsor details

c/o Assistant Professor Vibeke Zoffmann
Dyrehavevej 15 B
Hillerød
3400
Denmark
+45 2026 4339
gihu@hih.regionh.dk

Sponsor type

Hospital/treatment centre

Website

http://www.hillerodhospital.dk/menu/

Funders

Funder type

Charity

Funder name

Hillerød Hospital (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Region Hovedstadens Phd. fond (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novo Nordisk (Denmark)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Denmark

Funder name

Lundbeck (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sahva (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Trygfonden (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kaptajn Løjtnant and Wife (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21672252
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25118146

Publication citations

  1. Protocol

    Husted GR, Thorsteinsson B, Esbensen BA, Hommel E, Zoffmann V, Improving glycaemic control and life skills in adolescents with type 1 diabetes: a randomised, controlled intervention study using the Guided Self-Determination-Young method in triads of adolescents, parents and health care providers integrated into routine paediatric outpatient clinics., BMC Pediatr, 2011, 11, 55, doi: 10.1186/1471-2431-11-55.

  2. Results

    Husted GR, Thorsteinsson B, Esbensen BA, Gluud C, Winkel P, Hommel E, Zoffmann V, Effect of guided self-determination youth intervention integrated into outpatient visits versus treatment as usual on glycemic control and life skills: a randomized clinical trial in adolescents with type 1 diabetes., Trials, 2014, 15, 1, 321, doi: 10.1186/1745-6215-15-321.

Additional files

Editorial Notes