Zara Sandra, Kruse Johannes, Leveling Anna Maria, Schmitz Jana, Hempler Isabelle, Kampling Hanna
Department of Psychosomatic Medicine and Psychotherapy, Justus Liebig University Giessen, Giessen, Germany.
Department for Psychosomatic Medicine and Psychotherapy, Medical Center of the Philipps University Marburg, Marburg, Germany.
JMIR Res Protoc. 2022 Aug 1;11(8):e38477. doi: 10.2196/38477.
Diabetes is one of the most common diseases worldwide and is associated with increased morbidity, mortality, and reduced quality of life. Many patients experience high diabetes-related distress as well as depression and anxiety symptoms, which are associated with poor diabetes self-management. As disease management is a central component in diabetes treatment, poor management enhances the occurrence of micro- and macrovascular complications. This emphasizes the relevance of reducing diabetes-related distress and providing adequate treatment options addressing the individual psychosocial burden of patients with diabetes. Since patients' perspectives diverge significantly from those of practitioners in terms of relevant treatment aspects, the patient perspective on, for example, barriers to and facilitators of diabetes treatment is crucial for adequate and effective treatment as well as improvements to self-management and therefore, needs to be further explored.
This study aims to examine diabetes-related distress, the course of distress throughout diabetes management, as well as barriers and facilitating factors in dealing with diabetes from the individual perspective of patients with type 1 and type 2 diabetes.
The study employs a mixed methods design combining qualitative and quantitative data. Semistructured interviews (N=40) will be conducted with patients with type 1 diabetes (n=20) and patients with type 2 diabetes (n=20). The primary outcomes comprise (1) diabetes-related distress, (2) the severity of distress, (3) the course of distress throughout diabetes management, (4) barriers, and (5) facilitating factors. Questionnaires will provide data on the following secondary outcomes: diabetes-related emotional distress (the Problem Areas in Diabetes scale), symptoms of depression and anxiety (Patient Health Questionnaire, German version), personality functioning (Operationalized Psychodynamic Diagnosis-Structure Questionnaire), mentalizing capacities (Mentalization Questionnaire), epistemic trust (Epistemic Trust, Mistrust and Credulity Questionnaire) and experiences of child maltreatment (Childhood Trauma Questionnaire), and the overall health status of the patient (routine medical data).
As of April 2022, the conceptualization phase of the study was finalized. Ethics approval was received in January 2022 from the local ethics committee of the Justus Liebig University Giessen - Faculty of Medicine (AZ 161/21).
This study will provide insights into the individual perspective of patients with type 1 and type 2 diabetes regarding their experiences with diabetes management and what they perceive to be relevant, obstructive, or beneficial. The insights gained could help further tailor diabetes treatment to the individual needs of patients with diabetes and therefore optimize diabetes self-management.
German Clinical Trial Register DRKS00024999; https://tinyurl.com/2wb4xdh8.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/38477.
糖尿病是全球最常见的疾病之一，与发病率和死亡率上升以及生活质量下降相关。许多患者经历与糖尿病相关的高度痛苦以及抑郁和焦虑症状，这些与糖尿病自我管理不善有关。由于疾病管理是糖尿病治疗的核心组成部分，管理不善会增加微血管和大血管并发症的发生。这凸显了减轻与糖尿病相关的痛苦并提供适当治疗方案以解决糖尿病患者个体心理社会负担的重要性。由于患者在相关治疗方面的观点与从业者有很大差异，患者对糖尿病治疗的障碍和促进因素等方面的看法对于充分有效的治疗以及自我管理的改善至关重要，因此需要进一步探索。
本研究旨在从1型和2型糖尿病患者的个体角度，研究与糖尿病相关的痛苦、糖尿病管理过程中的痛苦历程以及应对糖尿病的障碍和促进因素。
本研究采用混合方法设计，结合定性和定量数据。将对20名1型糖尿病患者和20名2型糖尿病患者进行半结构化访谈（N = 40）。主要结果包括：（1）与糖尿病相关的痛苦；（2）痛苦的严重程度；（3）糖尿病管理过程中的痛苦历程；（4）障碍；（5）促进因素。问卷将提供以下次要结果的数据：与糖尿病相关的情绪困扰（糖尿病问题领域量表）、抑郁和焦虑症状（患者健康问卷，德文版）、人格功能（操作性心理动力诊断-结构问卷）、心理化能力（心理化问卷）、认知信任（认知信任、不信任和轻信问卷）以及儿童虐待经历（童年创伤问卷），以及患者的整体健康状况（常规医疗数据）。
截至2022年4月，该研究的概念化阶段已完成。2022年1月获得了吉森尤斯·利比希大学医学院当地伦理委员会的伦理批准（编号161/21）。
本研究将深入了解1型和2型糖尿病患者在糖尿病管理方面的个体观点，以及他们认为相关、阻碍或有益的因素。获得的见解有助于进一步根据糖尿病患者的个体需求调整糖尿病治疗，从而优化糖尿病自我管理。
德国临床试验注册中心DRKS00024999；https://tinyurl.com/2wb4xdh8。
国际注册报告识别码（IRRID）：PRR1-10.2196/38477。
