Individual goal-based plan based on nursing theory for adults with type 2 diabetes and self-care deficits: a study...

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.

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.

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.

ISRCTN10030245.