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

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.

Involving people with diabetes and the wider community in diabetes research: a realist review protocol.

BACKGROUND: Patient and public involvement in diabetes research is now actively encouraged in different countries because it is believed that involving people with experience of the condition will improve the quality and relevance of the research. However, reviews of patient involvement have noted that inadequate resources, patients' and communities' lack of research knowledge, and researchers' lack of skills to involve patients and communities in research may present significant contextual barriers. Little is known about the extent of patient/community involvement in designing or delivering interventions for people with diabetes. A realist review of involvement will contribute to assessing when, how and why involvement works, or does not work, to produce better diabetes interventions. METHODS/DESIGN: This protocol outlines the process for conducting a realist review to map how patients and the public have been involved in diabetes research to date. The review questions ask the following: How have people with diabetes and the wider community been involved in diabetes research? What are the characteristics of the process that appear to explain the relative success or failure of involvement? How has involvement (or lack of involvement) in diabetes research influenced the development and conduct of diabetes research? The degree of support in the surrounding context will be assessed alongside the ways in which people interact in different settings to identify patterns of interaction between context, mechanisms and outcomes in different research projects. The level and extent of the involvement will be described for each stage of the research project. The descriptions will be critically reviewed by the people with diabetes on our review team. In addition, researchers and patients in diabetes research will be asked to comment. Information from researcher-patient experiences and documents will be compared to theories of involvement across a range of disciplines to create a mid-range theory describing how involvement (or lack of involvement) in diabetes research influences the development and conduct of diabetes research.

Perceived family burden and emotional distress: similarities and differences between mothers and fathers of children with type 1 diabetes in a population-based study.

BACKGROUND: Parenting children with diabetes entail an extra burden for the families. More information is needed about associations between perceived family burden and emotional distress in both mothers and fathers. OBJECTIVE: To analyze (i) perceived burden and emotional distress in mothers and fathers of children with type 1 diabetes and (ii) associations between parental burden and distress and factors related to the child. METHODS: Mothers (n = 103) and fathers (n = 97) of 115 children (1-15 yr) with type 1 diabetes participated in this population-based survey. The parents completed the Hopkins Symptom Checklist-25 items (HSCL-25), measuring emotional distress, and the Family Burden Scale, which includes five questions measuring perceived family burden related to the child's diabetes. RESULTS: Both mothers and fathers reported that the greatest burden was related to long-term health concerns. The mothers reported a significantly greater burden related to medical treatment and significantly more emotional distress than the fathers. The mothers' perceived burden was significantly correlated with emotional distress. Nighttime blood glucose measurements were significantly associated with perceived parental burden, and experienced nocturnal hypoglycemia was significantly associated with parental emotional distress. CONCLUSIONS: The higher perceived burden related to medical treatment, the more emotional distress, and the correlations between burdens and emotional distress in mothers vs. fathers emphasize the importance of discussing both parents' roles and responsibilities in relation to the child's diabetes in follow-up. In the consultations, emphasizing nighttime caregiving and nocturnal hypoglycemia might also be important to prevent emotional distress.