Guided Self-determination - Promoting Self-management in Type 1 Diabetes (GSD)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes |
Behavioral: Guided self-determination |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study. |
- Change in HbA1c [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
- Who 5 [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
- TSRQ scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
- PAID scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
- Rosenberg's self-esteem scale [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
- PCD scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
- HCCQ scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
- DDS scales [ Time Frame: 0, 9 and 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 216 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2021 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lifestyle counselling |
Behavioral: Guided self-determination
Group counselling
|
|
Experimental: No intervention
Care as usual
|
Behavioral: Guided self-determination
Group counselling
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lars B. Nesje, MD, PhD | +47 5597 2980 | lnes@helse-bergen.no |
| Contact: Hrafnkell Thordarsson, MD | +47 5597 2628 | hraf@helse-bergen.no |
| Norway | |
| Helse Vest HF, Haukeland University Hospital | Recruiting |
| Bergen, Norway, 5021 | |
| Principal Investigator: | Marit Graue, RN, PhD | Bergen University College |
More Information
No publications provided
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT01317459 History of Changes |
| Other Study ID Numbers: | 2010/1325 |
| Study First Received: | March 11, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by Haukeland University Hospital:
|
Self management Diabetes type one Empowerment Intrinsic motivation |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013