Life skills for adolescents with type 1 diabetes and their parents

ISRCTN	ISRCTN54243636
DOI	https://doi.org/10.1186/ISRCTN54243636
Protocol serial number	1
Sponsor	Hillerød Hospital (Denmark)
Funders	Hillerød Hospital (Denmark), Region Hovedstadens Phd. fond (Denmark), Novo Nordisk (Denmark), Lundbeck (Denmark), Sahva (Denmark), Trygfonden (Denmark), Kaptajn Løjtnant and Wife (Denmark)

Submission date: 22/01/2010
Registration date: 08/03/2010
Last edited: 15/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Gitte Reventlov Husted
Scientific

Hillerød Hospital
Dyrehavevej 15B
Hillerød
3400
Denmark

Phone	+45 2026 4339
Email	gihu@hih.regionh.dk

Study information

Primary study design	Interventional
Study design	Interventional randomised controlled trial with a concurrent mixed methods design (quantitative and qualitative)
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Life skills for adolescents with type 1 diabetes and their parents: an interventional study with a concurrent mixed methods design
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
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
Key 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.
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	13 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	68
Key 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
Key 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
Date of first enrolment	09/09/2009
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

Denmark

Study participating centre

Hillerød Hospital

Hillerød
3400
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/08/2014		Yes	No
Protocol article	protocol	14/06/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes