Department of Internal Medicine, Erasmus MC Transplant Institute, University Medical Center, Dr. Molewaterplein 40, Rotterdam, 3015 GD, The Netherlands.
Department of Internal Medicine, Nursing Studies, Erasmus Medical Center, Rotterdam, The Netherlands.
Trials. 2022 Jan 6;23(1):14. doi: 10.1186/s13063-021-05896-0.
Recipients of an organ transplantation face a number of challenges and often need to change their health behaviour. Good self-management skills are essential for optimal clinical outcomes. However, few interventions are available to support post-transplant self-management. To fill this gap, we developed a self-management support intervention offered by nurse practitioners. The primary aim of the study is to implement and test the effectiveness of the ZENN intervention in promoting self-management skills among heart, kidney liver and lung transplant recipients in comparison to standard care. The secondary aim is to assess the self-management support skills of nurse practitioners who will deliver the intervention.
This multi-centre stepped-wedge randomized controlled trial will take place from September 2020 until May 2023. All departments will commence with inclusion of patients in the control period. Each department will be randomly assigned to a start date (step in the wedge) to commence the experimental period. Patients in the control period will receive standard care and will be asked to complete questionnaires at baseline (T0), 6 months (T1) and 12 months (T2), to assess self-management, self-regulation, quality of life and adherence. During the experimental period, patients will receive standard care plus the ZENN intervention and receive the same set of questionnaires as participants in the control period. Nurse practitioners will complete a baseline and follow-up questionnaire to assess differences in self-management support skills. Video recordings of outpatient clinic consultations during the control and experimental periods will determine the differences in nurses' needs-thwarting and needs-supporting skills between the control and experimental period.
The ZENN intervention could be a useful approach to support patients' self-management skills after organ transplantation and thus promote clinical outcomes as well as avoid adverse events.
Dutch Trial Register NL8469 . Registered on March 19, 2020.
器官移植受者面临许多挑战，通常需要改变其健康行为。良好的自我管理技能对于获得最佳临床结果至关重要。然而，支持移植后自我管理的干预措施却很少。为了弥补这一空白，我们开发了一种由护士从业者提供的自我管理支持干预措施。该研究的主要目的是实施并测试 ZENN 干预措施在促进心脏、肾脏、肝脏和肺移植受者自我管理技能方面的有效性，与标准护理相比。次要目的是评估实施干预措施的护士从业者的自我管理支持技能。
这是一项多中心分步楔形随机对照试验，将在 2020 年 9 月至 2023 年 5 月进行。所有科室都将在对照期开始纳入患者。每个科室将被随机分配一个开始日期（楔形中的一个步骤）开始实验期。对照期的患者将接受标准护理，并被要求在基线（T0）、6 个月（T1）和 12 个月（T2）时完成问卷，以评估自我管理、自我调节、生活质量和依从性。在实验期间，患者将接受标准护理加 ZENN 干预，并接受与对照组相同的问卷。护士从业者将完成基线和随访问卷，以评估自我管理支持技能的差异。对照期和实验期门诊咨询的视频记录将确定对照期和实验期护士的需求挫败和需求支持技能之间的差异。
ZENN 干预措施可能是一种支持患者器官移植后自我管理技能的有用方法，从而促进临床结果，避免不良事件。
荷兰试验注册 NL8469。于 2020 年 3 月 19 日注册。
