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21 March 2013
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| [ Print-friendly version ] |
| A new beginning in life for young adults with poorly controlled type 1 diabetes |
| ISRCTN | ISRCTN70566290 |
| DOI | 10.1186/ISRCTN70566290 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | A new beginning in life for young adults with poorly controlled type 1 diabetes |
| Scientific title | Guided self-determination tested in a flexible program for young adults with poorly controlled type 1 diabetes: a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | It is hypothesised that attending in a group based or individual course using Guided Self-determination (GSD) will improve the way young adults with poorly controlled type 1 diabetes live with their illness. The null hypothesis of no difference will be rejected if participants in the intervention group compared to those in a control group have decreased their HbA1c and improved their psychosocial functioning 18 months after the intervention. |
| Lay summary |
Background and study aims:
Being young and having to face a life with a chronic condition is a great challenge. In diabetes care more than half of the patients with type 1 diabetes live with poor glycaemic control which can lead to increased risk of diabetes related complications and poor quality of life. This study investigates patients’ own judgement of their situation and the problems connected with diabetes self-management. Who can participate? Young adults aged 18-35 years old, who have had type 1 diabetes for at least 1 year. What does the study involve? Participants are randomly distributed to having GSD immediately or 18 months delayed. They choose whether the course should have an individual or a group based form. Patients fill in reflection sheets before each appointment and talk with GSD-trained nurses about the issues they have written or drawn on the sheets. Through this process the young adults discover new aspects of their own way of living with the illness and also a new potential for managing diabetes in daily life. The nurses also discover new aspects in each patient’s life and thereby become able to support patients in finding their own way in managing the situation. What are the possible benefits and risks of participating? Participants will benefit from the course by learning to better control their diabetes. There are no known risks associated with taking part in this study. Where is the study run from? Steno Diabetes Center, Denmark When is the study starting and how long is it expected to run for? The study started n March 2010 and is due to end in September 2013. Who is funding the study? Steno Diabetes Center, Denmark Danish National Board of Health, Denmark Novo Nordisk - Department of Global Health, Denmark Who is the main contact? Vibeke Zoffmann vzof@steno.dk |
| Ethics approval |
The National Committee on Health Research Ethics ref: H-D-2009-Fsp-29
The Danish Data Protection Agency ref: 2010-41-5448 |
| Study design | Randomized controlled trial a waitlist design |
| Countries of recruitment | Denmark |
| Disease/condition/study domain | Type 1 diabetes in poor control |
| Participants - inclusion criteria |
1. Young adults, 18-35 years old with duration of type 1 diabetes at least 1 year
2. HbA1c at least 8.0% and mean HbA1c during the past 1-2 years at least 7.5% |
| Participants - exclusion criteria | Young adults who due to mental or physical state and language barriers are unable to read and reflect on the reflection sheets used in GSD |
| Anticipated start date | 01/03/2010 |
| Anticipated end date | 30/09/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 200 |
| Interventions | Participants are by chance distributed 2:1 to having GSD immediately or 18 months delayed. They choose whether the course should have an individual form (eight 1-hour sessions in day time) or a group based form (eight 2½-hour sessions late afternoon). Patients fill in reflection sheets before each appointment and talk with GSD-trained nurses about the issues they have written or drawn on the sheets. Through this process the young adults discover new aspects of their own way of living with the illness and also a new potential for managing diabetes in daily life. The nurses also discover new aspects in each patient’s life and thereby become able to support patients in finding their own way in managing the situation. As part of GSD, advantages and disadvantages of different levels of HbA1c are also translated to patients in a meaningful way allowing patients to take autonomous decisions about their own goals which consequently in higher degree will be self-concordant. |
| Primary outcome measure(s) | HbA1c |
| Secondary outcome measure(s) |
1. Health Care Climate Questionnaire (HCCQ)
2. Treatment Self Regulation Questionnaire (TSRQ) 3. Problem Areas In Diabetes (PAID) 4. Perceived Competence with diabetes (PCD) 5. WHO-5 6. Rosenberg’s self-esteem scale (RSES) 7. Self-monitored blood-glucoses (SMBG) per week 8.Cancellations or failures to show-up 9. Type and amount of insulin treatment. |
| Sources of funding |
Steno Diabetes Center [Kliniske udviklingsmidler] (Denmark)
Danish national Board of Health (Denmark) ref: 7-203-02-434/5 Novo Nordisk Department of Global Health (Denmark) |
| Trial website | |
| Publications | |
| Contact name | Dr Vibeke Zoffmann |
| Address |
Steno Diabetes Center
Jellerød Have 32 |
| City/town | Kokkedal |
| Zip/Postcode | 2980 |
| Country | Denmark |
| Sponsor | Steno Diabetes Center (Denmark) |
| Address | Niels Steensens vej 2 |
| City/town | Gentofte |
| Zip/Postcode | 2820 |
| Country | Denmark |
| Sponsor website: | http://www.steno.dk/documents/home_page/document/index.asp |
| Date applied | 02/12/2012 |
| Last edited | 12/12/2012 |
| Date ISRCTN assigned | 12/12/2012 |
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| © 2013 ISRCTN unless otherwise stated. | |
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