Guided Self-determination - Promoting Self-management in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Guided self-determination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counselling<br> | Behavioral: Guided self-determination<br>* Group counselling<br>|
| Experimental: No intervention<br>Care as usual | Behavioral: Guided self-determination<br>* Group counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 0, 9 and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Who 5 |  | 0, 9 and 18 months | 
| TSRQ scales |  | 0, 9 and 18 months | 
| PAID scales |  | 0, 9 and 18 months | 
| Rosenberg's self-esteem scale |  | 0, 9 and 18 months | 
| PCD scales |  | 0, 9 and 18 months | 
| HCCQ scales |  | 0, 9 and 18 months | 
| DDS scales |  | 0, 9 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self management, Diabetes type one, Empowerment, Intrinsic motivation