Clinical trial NCT01317459: Guided Self-determination - Promoting Self-management in Type 1 Diabetes
Official title: Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: Self management
Diabetes type one
Empowerment
Intrinsic motivation
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 0, 9 and 18 months
Secondary outcomes:
measure: Who 5
timeFrame: 0, 9 and 18 months
measure: TSRQ scales
timeFrame: 0, 9 and 18 months
measure: PAID scales
timeFrame: 0, 9 and 18 months
measure: Rosenberg's self-esteem scale
timeFrame: 0, 9 and 18 months
measure: PCD scales
timeFrame: 0, 9 and 18 months
measure: HCCQ scales
timeFrame: 0, 9 and 18 months
measure: DDS scales
timeFrame: 0, 9 and 18 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Helse Vest HF, Haukeland University Hospital
Study officials:
affiliation: Bergen University College
name: Marit Graue, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohn J, Igland J, Zoffmann V, Peyrot M, Graue M. Factors explaining variation in self-esteem among persons with type 1 diabetes and elevated HbA1c. PLoS One. 2018 Aug 10;13(8):e0201006. doi: 10.1371/journal.pone.0201006. eCollection 2018.
citation: Mohn J, Graue M, Assmus J, Zoffmann V, Thordarson H, Peyrot M, Rokne B. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c >/=64 mmol/mol: a group-based randomised controlled trial. BMJ Open. 2017 Jul 3;7(6):e013295. doi: 10.1136/bmjopen-2016-013295.