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Life skills for adolescents with type 1 diabetes and their parents
ISRCTN ISRCTN54243636
DOI 10.1186/ISRCTN54243636
ClinicalTrials.gov identifier
EudraCT number
Public title Life skills for adolescents with type 1 diabetes and their parents
Scientific title Life skills for adolescents with type 1 diabetes and their parents: an interventional study with a concurrent mixed methods design
Acronym N/A
Serial number at source 1
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.
Lay summary Not provided at time of registration
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)
Countries of recruitment Denmark
Disease/condition/study domain Type I diabetes
Participants - 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
Participants - 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
Anticipated start date 09/09/2009
Anticipated end date 01/01/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 68 adolescents and (n) parents
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding 1. Hillerød Hospital (Denmark)
2. Region Hovedstadens Phd. fond (Denmark)
3. Novo Nordisk (Denmark)
4. Lundbeck (Denmark)
5. Sahva (Denmark)
6. Trygfonden (Denmark)
7. Kaptajn Løjtnant and Wife (Denmark)
Trial website
Publications 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21672252
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25118146
Contact name Mrs  Gitte Reventlov  Husted
  Address Hillerød Hospital
Dyrehavevej 15B
  City/town Hillerød
  Zip/Postcode 3400
  Country Denmark
  Tel +45 2026 4339
  Fax +45 4829 4859
  Email gihu@hih.regionh.dk
Sponsor Hillerød Hospital (Denmark)
  Address c/o Assistant Professor Vibeke Zoffmann
Dyrehavevej 15 B
  City/town Hillerød
  Zip/Postcode 3400
  Country Denmark
  Tel +45 2026 4339
  Fax +45 4829 4859
  Email gihu@hih.regionh.dk
  Sponsor website: http://www.hillerodhospital.dk/menu/
Date applied 22/01/2010
Last edited 15/08/2014
Date ISRCTN assigned 08/03/2010
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