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

Diabetes Clinical Trial

— GSD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01317459
• Other study ID #: 2010/1325
• Status: Active, not recruiting
• Phase: N/A
• First received: March 11, 2011
• Last updated: September 9, 2015
• Start date: March 2011
• Est. completion date: December 2021

Study information

• Verified date: September 2015
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Guided self-determination
Group counselling

Locations

Country	Name	City	State
Norway	Helse Vest HF, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		0, 9 and 18 months	No
Secondary	Who 5		0, 9 and 18 months	No
Secondary	TSRQ scales		0, 9 and 18 months	No
Secondary	PAID scales		0, 9 and 18 months	No
Secondary	Rosenberg's self-esteem scale		0, 9 and 18 months	No
Secondary	PCD scales		0, 9 and 18 months	No
Secondary	HCCQ scales		0, 9 and 18 months	No
Secondary	DDS scales		0, 9 and 18 months	No