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

NCT ID: NCT01317459

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2021-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lifestyle counselling

Group Type: EXPERIMENTAL

Guided self-determination

Intervention Type: BEHAVIORAL

Group counselling

No intervention

Care as usual

Group Type: EXPERIMENTAL

Guided self-determination

Intervention Type: BEHAVIORAL

Group counselling

Interventions

Guided self-determination

Group counselling

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marit Graue, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Bergen University College

Locations

Helse Vest HF, Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 30096144 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28674125 (View on PubMed)

Other Identifiers

2010/1325

Identifier Type: -

Identifier Source: org_study_id