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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01317459
Recruitment Status : Active, not recruiting
First Posted : March 17, 2011
Last Update Posted : September 10, 2015
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Guided self-determination Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.
Study Start Date : March 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Lifestyle counselling Behavioral: Guided self-determination
Group counselling

Experimental: No intervention
Care as usual
Behavioral: Guided self-determination
Group counselling

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 0, 9 and 18 months ]

Secondary Outcome Measures :
  1. Who 5 [ Time Frame: 0, 9 and 18 months ]
  2. TSRQ scales [ Time Frame: 0, 9 and 18 months ]
  3. PAID scales [ Time Frame: 0, 9 and 18 months ]
  4. Rosenberg's self-esteem scale [ Time Frame: 0, 9 and 18 months ]
  5. PCD scales [ Time Frame: 0, 9 and 18 months ]
  6. HCCQ scales [ Time Frame: 0, 9 and 18 months ]
  7. DDS scales [ Time Frame: 0, 9 and 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01317459

Helse Vest HF, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Principal Investigator: Marit Graue, RN, PhD Bergen University College

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Haukeland University Hospital Identifier: NCT01317459     History of Changes
Other Study ID Numbers: 2010/1325
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015

Keywords provided by Haukeland University Hospital:
Self management
Diabetes type one
Intrinsic motivation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases