Viewing Study NCT01317459


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Study NCT ID: NCT01317459
Status: UNKNOWN
Last Update Posted: 2015-09-10
First Post: 2011-03-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Guided Self-determination - Promoting Self-management in Type 1 Diabetes
Sponsor: Haukeland University Hospital
Organization:

Study Overview

Official Title: Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.
Status: UNKNOWN
Status Verified Date: 2015-09
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GSD
Brief Summary: 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: