Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, the Netherlands.
Department of Nephrology, Radboud Institute for Health Sciences, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.
Trials. 2022 Jun 7;23(1):477. doi: 10.1186/s13063-022-06392-9.
Kidney failure and dialysis treatment have a large impact on a patient's life. Patients experience numerous, complex symptoms and usually have multiple comorbid conditions. Despite the multitude of problems, patients often have priorities for improvement of specific aspects of their functioning, which would be helpful for clinicians to become informed of. This highlights a clear need for patient-centered care in this particular patient group, with routine screening as a vital element to timely recognize symptoms and tailored treatment to match individual patients' needs and priorities. By also providing feedback on patient's screening results to the patient itself, the patient is empowered to actively take control in one's mostly uncontrollable disease process. The current paper describes the study design of a multicenter randomized controlled trial evaluating the effectiveness of the "E-HEealth treatment in Long-term Dialysis" (E-HELD) intervention. This therapist-guided Internet-based cognitive-behavioral therapy (ICBT) intervention is focused on and personalized to the myriad of problems that dialysis patients experience and prioritize.
After a screening procedure on adjustment problems, 130 eligible dialysis patients will be randomized to care as usual or the E-HELD intervention. Patients will complete questionnaires on distress (primary outcome measure), several domains of functioning (e.g., physical, psychological, social), potential predictors and mediators of treatment success, and the cost-effectiveness of the intervention, at baseline, 6-month follow-up, and 12-month follow-up. In addition, to take account of the personalized character of the intervention, the Personalized Priority and Progress Questionnaire (PPPQ) will be administered which is a personalized instrument to identify, prioritize, and monitor individual problems over time.
The present study design will provide insight in the effectiveness of tailored ICBT in patients with kidney failure who are treated with dialysis. When proven effective, the screening procedure and the subsequent ICBT intervention could be implemented in routine care to detect, support, and treat patients struggling with adjustment problems.
NL63422.058.17 [Registry ID: METC-LDD] NL7160 [Netherlands Trial Register; registered on 16 July 2018].
肾衰竭和透析治疗对患者的生活有很大影响。患者会经历许多复杂的症状，通常还会有多种合并症。尽管存在许多问题，但患者通常会优先改善其特定功能方面，这将有助于临床医生了解患者的需求。这突出表明，在这群特定的患者中，需要以患者为中心的护理，常规筛查是及时识别症状和针对个体患者的需求和优先级制定个性化治疗方案的重要组成部分。通过向患者本人反馈患者的筛查结果，患者可以积极控制自己在无法控制的疾病过程中。本文介绍了一项多中心随机对照试验的研究设计，该试验评估了“长期透析的 E-HEalth 治疗”（E-HELD）干预措施的有效性。这种由治疗师指导的基于互联网的认知行为疗法（ICBT）干预措施针对并针对透析患者所经历的和优先考虑的无数问题进行了个性化定制。
在进行调整问题的筛查程序后，将对 130 名符合条件的透析患者进行随机分组，分别接受常规护理或 E-HELD 干预。患者将在基线、6 个月随访和 12 个月随访时，填写关于痛苦（主要结局指标）、多个功能领域（如身体、心理、社会）、治疗成功的潜在预测因素和中介因素，以及干预的成本效益的问卷。此外，为了考虑到干预措施的个性化特点，将使用个性化优先级和进展问卷（PPPQ）进行评估，这是一种个性化的工具，可以随着时间的推移识别、优先考虑和监测个人问题。
本研究设计将为针对接受透析治疗的肾衰竭患者进行个体化 ICBT 的有效性提供深入了解。当被证明有效时，筛选程序和随后的 ICBT 干预措施可以在常规护理中实施，以发现、支持和治疗那些正在努力调整的患者。
NL63422.058.17[注册号：METC-LDD]NL7160[荷兰试验注册；于 2018 年 7 月 16 日注册]。
