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

H

Haukeland University Hospital

Status

Unknown

Conditions

Diabetes

Treatments

Behavioral: Guided self-determination

Study type

Interventional

Funder types

Other

Identifiers

NCT01317459
2010/1325

Details and patient eligibility

About

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.

Enrollment

216 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

216 participants in 2 patient groups

Lifestyle counselling
Experimental group
Treatment:
Behavioral: Guided self-determination
No intervention
Experimental group
Description:
Care as usual
Treatment:
Behavioral: Guided self-determination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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