- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Bergen, Norge, 5021
- Helse Vest HF, Haukeland University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Livsstilsrådgivning
|
Group counselling
|
|
Experimentell: No intervention
Care as usual
|
Group counselling
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in HbA1c
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Who 5
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
TSRQ scales
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
PAID scales
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
Rosenberg's self-esteem scale
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
PCD scales
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
HCCQ scales
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
DDS scales
Tidsram: 0, 9 and 18 months
|
0, 9 and 18 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Marit Graue, RN, PhD, Bergen University College
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2010/1325
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