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- Klinische proef NCT01317459
Guided Self-determination - Promoting Self-management in Type 1 Diabetes (GSD)
Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.
Background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. The need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. At present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved.
Aim and Methods: Guided self-determination (GSD) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. In this evidence-based group-intervention the main objective is to implement and evaluate GSD through a randomised controlled trial. GSD methods will be performed seven times for the intervention group. The control group will receive traditional out-patient consultations - 'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. GSD is presumably an intervention providing psychosocial support applicable in busy clinical practice.
An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College, and Bergen University to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Bergen, Noorwegen, 5021
- Helse Vest HF, Haukeland University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Diabetes type one, HbA1c >= 8%
Exclusion Criteria:
Pregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the Norwegian language
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Leefstijlbegeleiding
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Group counselling
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Experimenteel: No intervention
Care as usual
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Group counselling
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in HbA1c
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Who 5
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
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TSRQ scales
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
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PAID scales
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
|
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Rosenberg's self-esteem scale
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
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PCD scales
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
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HCCQ scales
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
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DDS scales
Tijdsspanne: 0, 9 and 18 months
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0, 9 and 18 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Marit Graue, RN, PhD, Bergen University College
Publicaties en nuttige links
Algemene publicaties
- Mohn J, Igland J, Zoffmann V, Peyrot M, Graue M. Factors explaining variation in self-esteem among persons with type 1 diabetes and elevated HbA1c. PLoS One. 2018 Aug 10;13(8):e0201006. doi: 10.1371/journal.pone.0201006. eCollection 2018.
- Mohn J, Graue M, Assmus J, Zoffmann V, Thordarson H, Peyrot M, Rokne B. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c >/=64 mmol/mol: a group-based randomised controlled trial. BMJ Open. 2017 Jul 3;7(6):e013295. doi: 10.1136/bmjopen-2016-013295.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2010/1325
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