Individual goal-based plan based on nursing theory for adults with type 2 diabetes and self-care deficits: a study protocol of a randomised controlled trial

INTRODUCTION: The prevalence and costs of type 2 diabetes are increasing worldwide. A cornerstone in the treatment and care of diabetes is supporting each patient in self-management. In Sweden, most patients with type 2 diabetes are cared for in the primary care setting, which is heavily burdened. Because of implementation difficulties regarding evidenced-based diabetes self-management education and support in this setting, there is a need for an instrument that is easy to use and implement. We developed an individual care plan based on the self-care deficit nursing theory of Dorothea Orem as an instrument to facilitate more individualised self-care support for patients with type 2 diabetes. In this study, we aim to determine whether a written, theory-based, individual goal-based plan for patients with type 2 diabetes and self-management deficits can affect their glycaemic control and health-related quality of life, as well as their experiences of living with diabetes and of support from diabetes care. METHODS AND ANALYSIS: The study design is a randomised controlled trial using a quantitative approach. A total of 110 patients will be included. Additionally, a qualitative interview study will be conducted 12 months after the intervention. The primary outcome will be glycosylated haemoglobin levels. Secondary outcomes will be health-related quality of life measured using the RAND-36, and the patient's experience of living with diabetes and of the support from diabetes care measured using the Diabetes Questionnaire. Quantitative data will be analysed using the paired t-test, unpaired t-test, and Mann-Whitney U test with IBM SPSS V.26.0 software. Qualitative content analysis will be used for qualitative data. ETHICS AND DISSEMINATION: This study has been approved by the Ethical Review Authority in Uppsala, Sweden (Etikprövningsmyndigheten, Uppsala, Sverige) (Dnr: 2020-03421). The results will be disseminated in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN10030245.