Department of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden
Primary Care and Health, Uppsala County Council, Uppsala, Sweden.
BMJ Open. 2022 Mar 29;12(3):e053955. doi: 10.1136/bmjopen-2021-053955.
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.
2 型糖尿病的患病率和成本在全球范围内都在上升。支持每位患者进行自我管理是糖尿病治疗和护理的基石。在瑞典，大多数 2 型糖尿病患者在初级保健环境中接受治疗，而初级保健环境的负担非常沉重。由于在这种环境中实施基于证据的糖尿病自我管理教育和支持存在实施困难，因此需要一种易于使用和实施的工具。我们基于 Dorothea Orem 的自我护理缺陷护理理论开发了一种个体化护理计划，作为一种工具，以促进为 2 型糖尿病患者提供更个性化的自我护理支持。在这项研究中，我们旨在确定针对 2 型糖尿病和自我管理缺陷患者的书面、基于理论、个体化目标为本的计划是否可以影响他们的血糖控制和健康相关生活质量，以及他们对糖尿病的生活体验和对糖尿病护理的支持体验。
研究设计是一项采用定量方法的随机对照试验。总共将纳入 110 名患者。此外，还将在干预后 12 个月进行定性访谈研究。主要结局指标将是糖化血红蛋白水平。次要结局指标将是使用 RAND-36 测量的健康相关生活质量，以及患者对糖尿病的生活体验和对糖尿病护理的支持体验使用糖尿病问卷进行测量。使用 IBM SPSS V.26.0 软件对定量数据进行配对 t 检验、非配对 t 检验和曼-惠特尼 U 检验进行分析。对定性数据进行定性内容分析。
这项研究已经得到瑞典乌普萨拉伦理审查局（Etikprövningsmyndigheten， Uppsala，Sverige）的批准（Dnr：2020-03421）。结果将在同行评议的出版物中公布。
ISRCTN85556555。
