Life skills for adolescents with type 1 diabetes and their parents
| ISRCTN | ISRCTN54243636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54243636 |
| Secondary identifying numbers | 1 |
- 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
Scientific
Hillerød Hospital
Dyrehavevej 15B
Hillerød
3400
Denmark
| Phone | +45 2026 4339 |
|---|---|
| gihu@hih.regionh.dk |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 09/09/2009 |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 68 adolescents and (n) parents |
| 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
3400
Denmark
Sponsor information
Hillerød Hospital (Denmark)
Hospital/treatment centre
Hospital/treatment centre
c/o Assistant Professor Vibeke Zoffmann
Dyrehavevej 15 B
Hillerød
3400
Denmark
| Phone | +45 2026 4339 |
|---|---|
| gihu@hih.regionh.dk | |
| Website | http://www.hillerodhospital.dk/menu/ |
Funders
Funder type
Charity
Hillerød Hospital (Denmark)
No information available
Region Hovedstadens Phd. fond (Denmark)
No information available
Novo Nordisk (Denmark)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novo Nordisk Global
- Location
- Denmark
Lundbeck (Denmark)
No information available
Sahva (Denmark)
No information available
Trygfonden (Denmark)
No information available
Kaptajn Løjtnant and Wife (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/06/2011 | Yes | No | |
| Results article | results | 12/08/2014 | Yes | No |
