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Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol.

Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol.
Author Information (click to view)

Karlsen B, Oftedal B, Stangeland Lie S, Rokne B, Peyrot M, Zoffmann V, Graue M,


Karlsen B, Oftedal B, Stangeland Lie S, Rokne B, Peyrot M, Zoffmann V, Graue M, (click to view)

Karlsen B, Oftedal B, Stangeland Lie S, Rokne B, Peyrot M, Zoffmann V, Graue M,

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BMJ open 2016 12 136(12) e013026 doi 10.1136/bmjopen-2016-013026
Abstract
INTRODUCTION
Self-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous results of such interventions, interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. This study is designed to assess the effectiveness of a theory-driven web-based Guided Self-Determination (GSD) intervention among adults with T2DM in general practice to improve diabetes self-management behaviours and glycosylated haemoglobin (HbA1c).

METHODS AND ANALYSIS
A complex intervention design based on the framework of the UK Medical Research Council is employed as a guide for developing the intervention, assessing its feasibility and evaluating its effectiveness. The study consists of three phases: (1) the modelling phase adapting the original GSD programme for adults with T2DM, using a qualitative design, (2) feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and (3) evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design. The first phase, which is completed, and the second phase, which is underway, will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effectiveness of this systematically developed intervention.

ETHICS AND DISSEMINATION
The Norwegian Regional Committee for Medical and Health Research Ethics (REK west number 2015/60) has approved the study design. Patients recruited in the different phases will fill out an informed consent form prior to inclusion and will be guaranteed anonymity and the right to withdraw from the study at any time. The results of the study will be published in peer-reviewed journals, electronically and in print, and presented at research conferences.

TRIAL REGISTRATION NUMBER
NCT02575599.

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