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

Not Applicable

• Conditions: Diabetes
• Interventions: Behavioral: Guided self-determination

• Registration Number: NCT01317459
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10
• Primary Completion: 2016-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counselling	Guided self-determination	-
No intervention	Guided self-determination	Care as usual

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	0, 9 and 18 months

Secondary Outcome Measures

Name	Time	Method
PCD scales	0, 9 and 18 months
DDS scales	0, 9 and 18 months
TSRQ scales	0, 9 and 18 months
Who 5	0, 9 and 18 months
PAID scales	0, 9 and 18 months
Rosenberg's self-esteem scale	0, 9 and 18 months
HCCQ scales	0, 9 and 18 months

Trial Locations

Locations (1)

Helse Vest HF, Haukeland University Hospital; 🇳🇴 Bergen, Norway