Overview

This trial is active, not recruiting.

Condition diabetes
Treatment guided self-determination
Sponsor Haukeland University Hospital
Start date March 2011
End date December 2016
Trial size 216 participants
Trial identifier NCT01317459, 2010/1325

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
guided self-determination
Group counselling
(Experimental)
Care as usual
guided self-determination
Group counselling

Primary Outcomes

Measure
Change in HbA1c
time frame: 0, 9 and 18 months

Secondary Outcomes

Measure
Who 5
time frame: 0, 9 and 18 months
TSRQ scales
time frame: 0, 9 and 18 months
PAID scales
time frame: 0, 9 and 18 months
Rosenberg's self-esteem scale
time frame: 0, 9 and 18 months
PCD scales
time frame: 0, 9 and 18 months
HCCQ scales
time frame: 0, 9 and 18 months
DDS scales
time frame: 0, 9 and 18 months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.
Principal investigator Marit Graue, RN, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.