An interventional study of Guided self-determination programme (GSD) in Type 2 Diabetes, sponsored by University of Stavanger. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-02.
Sponsored by University of Stavanger · Not applicable, Interventional, and Supportive care
The overall aim of this study is to assess the effectiveness of a web-based Guided Self-Determination program among adults with type 2 diabetes in general practice in order to improve diabetes self-management behaviours and HbA1c through enhanced patient activation, self-care competence, and autonomy.
Web-based self-management programs have the potential to support adults with type 2 diabetes in managing their disease condition. However, improving health care outcomes through self-management interventions have shown somewhat ambiguous results. Therefore, it is suggested that interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. To meet these challenges, the overall aim of this study is to assess the effectiveness of a theory-driven web-based Guided Self-Determination intervention among adults with type 2 diabetes in general practice in order to enable adults with diabetes to use their individual resources to self-manage their condition and reach treatment goals.
A complex intervention design based on the framework of UK Medical Research Council is employed as a guide for developing and evaluating the intervention.
This study consists of three phases:
The two first phases will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effect on health care outcomes of this systematically developed intervention.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 172 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Stavanger is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Intervention group: Eighty six adults with type 2 diabetes will be recruited from the general practices where the trained nurses in Guided self-determination programme are working.
Behavioral: Guided self-determination programme (GSD)
Control group: Eighty six adults with type 2 diabetes will be recruited from general practices with employed registered nurses without the Guided self-determination training.
The GSD intervention consist of four e-consultations with structured reflection sheets. Reflection sheets are intended to increase patients' ability to express their views and prepare them for active participation in the care process. Through the web-based platform, the subsequent four e-consultations will allow for communication between patients and nurses. The platform allows the participants to fill in the reflection sheets using their own words and drawings to express their own experiences with self-management as well as to formulate behavioral goals and plans to achieve their goals. It also permits feedback from the nurses on these reflections sheets via secure emails. Each person will be able to access the web-based program from his or her own computers or other electronic devices.
The Patient Activation Measure (PAM)
Time frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
The Health Care Climate Questionnaire (HCCQ)
Time frame: Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months
Perceived Competence for Diabetes Scale (PCDS)
Time frame: Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months
Treatment Self-Regulation (TSRQ)
Time frame: At three time points: at baseline, 12-16 weeks later at the end of the intervention and six months after finishing the intervention.
Diabetes Management Self-efficacy Scale (SE-type 2 diabetes)
Time frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Summary of diabetes self-care activities (SDSCA)
Time frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
The WHO 5-item Well-Being Index (WHO-5)
Time frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
Diabetes Distress Scale (DDS)
Time frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
Glycosylated haemoglobin (HbA1c)
Time frame: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months
No study locations are listed for this record.
Start is estimated for Sep 2018; primary completion for Sep 2019, 12 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University of Stavanger