- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Bergen, Norge, 5021
- Helse Vest HF, Haukeland University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Livsstilsrådgivning
|
Group counselling
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Eksperimentell: No intervention
Care as usual
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Group counselling
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in HbA1c
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Who 5
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
TSRQ scales
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
PAID scales
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
Rosenberg's self-esteem scale
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
PCD scales
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
HCCQ scales
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
|
DDS scales
Tidsramme: 0, 9 and 18 months
|
0, 9 and 18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Marit Graue, RN, PhD, Bergen University College
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2010/1325
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