title: Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol.
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02575599.
authors.affiliation: Department of Health Studies, University of Stavanger, Stavanger, Norway.
authors.forename: Bjørg
authors.initials: B
authors.lastname: Karlsen
authors.affiliation: Department of Health Studies, University of Stavanger, Stavanger, Norway.
authors.forename: Bjørg
authors.initials: B
authors.lastname: Oftedal
authors.affiliation: Department of Health Studies, University of Stavanger, Stavanger, Norway.
authors.forename: Silje
authors.initials: S
authors.lastname: Stangeland Lie
authors.affiliation: Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
authors.forename: Berit
authors.initials: B
authors.lastname: Rokne
authors.affiliation: Sociology Department, Loyola University Maryland, Baltimore, Maryland, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Peyrot
authors.affiliation: Juliane Marie Centre, University Hospital of Copenhagen, Copenhagen, Denmark.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Zoffmann
authors.affiliation: Centre for Evidence-Based Practice, Bergen University College, Bergen, Norway.
authors.forename: Marit
authors.initials: M
authors.lastname: Graue
mesh_terms: D000328:Adult; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D005260:Female; D058006:General Practice / Q000458:organization & administration; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D020407:Internet; D008297:Male; D009664:Norway; D026684:Personal Autonomy; D017410:Practice Guidelines as Topic; D012044:Regression Analysis; D012107:Research Design; D012648:Self Care / Q000379:methods*
chemical_list: D006442:Glycated Hemoglobin
keywords: DIABETES & ENDOCRINOLOGY; MEDICAL EDUCATION & TRAINING; PRIMARY CARE