Guided Self-determination - Promoting Self-management in Type 1 Diabetes (GSD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01317459
First received: March 11, 2011
Last updated: September 24, 2013
Last verified: September 2013

March 11, 2011
September 24, 2013
March 2011
December 2013   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01317459 on ClinicalTrials.gov Archive Site
  • Who 5 [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • TSRQ scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • PAID scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • Rosenberg's self-esteem scale [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • PCD scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • HCCQ scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
  • DDS scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Guided Self-determination - Promoting Self-management in Type 1 Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes
Behavioral: Guided self-determination
Group counselling
  • Experimental: Lifestyle counselling
    Intervention: Behavioral: Guided self-determination
  • Experimental: No intervention
    Care as usual
    Intervention: Behavioral: Guided self-determination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
216
December 2021
December 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01317459
2010/1325
No
Haukeland University Hospital
Haukeland University Hospital
Not Provided
Principal Investigator: Marit Graue, RN, PhD Bergen University College
Haukeland University Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP