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器官移植后由护士主导的自我管理支持——一项多中心、阶梯式楔形随机对照试验

Nurse-Led Self-Management Support After Organ Transplantation - A Multicenter, Stepped-Wedge Randomized Controlled Trial.

作者信息

van Zanten Regina, van Dijk Monique, van Rosmalen Joost, Beck Denise K, van Staa AnneLoes, Van Hecke Ann, Massey Emma K

机构信息

Department of Internal Medicine, Erasmus MC Transplant Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.

Department of Internal Medicine, Section Nursing Science, Erasmus Medical Center, Rotterdam, Netherlands.

出版信息

Transpl Int. 2025 Jan 6;37:13175. doi: 10.3389/ti.2024.13175. eCollection 2024.

Abstract

UNLABELLED

In this unblinded multi-center stepped-wedge randomized controlled trial the effectiveness of the nurse-led ZENN-intervention was tested in promoting self-management skills in comparison to standard care among heart, lung and kidney transplant recipients. This intervention is based on behaviour change theories and was conducted in four sessions over 6 months at the outpatient clinic. The experimental group received standard care, plus the ZENN-intervention, while the control group received only standard care. Both groups completed questionnaires at baseline, at 6 months and 1 year follow-up. At baseline, the experimental group (n = 69) scored significantly lower than the control group (n = 106) on the primary outcome Skills and Technique Acquisition (STA). No significant between-group differences were found on the secondary outcomes self-management, self-regulation, quality of life and medication adherence at T1 and T2. There was a significant increase on the self-management scale STA between T0 and T1 in the experimental group. Therefore, participants included in the experimental group had lower self-management skills at baseline and reported significant improvement after completing the intervention. No significant intervention effect was found in the primary analysis, however, for recipients with reduced self-management skills the intervention may be beneficial.

CLINICAL TRIAL REGISTRATION

https://onderzoekmetmensen.nl/en/trial/24150, Netherlands Trial Register NL8469.

摘要

未标注

在这项非盲法多中心阶梯楔形随机对照试验中,研究了由护士主导的ZENN干预措施相较于标准护理,在促进心脏、肺和肾移植受者自我管理技能方面的有效性。该干预措施基于行为改变理论,在门诊进行,为期6个月,共四期。实验组接受标准护理加ZENN干预,而对照组仅接受标准护理。两组在基线、6个月和1年随访时均完成问卷调查。在基线时,实验组(n = 69)在主要结局技能与技术获取(STA)方面的得分显著低于对照组(n = 106)。在T1和T2时,两组在次要结局自我管理、自我调节、生活质量和药物依从性方面未发现显著差异。实验组在T0和T1之间的自我管理量表STA上有显著增加。因此,纳入实验组的参与者在基线时自我管理技能较低,在完成干预后报告有显著改善。然而,在初步分析中未发现显著的干预效果,不过,对于自我管理技能降低的受者,该干预可能有益。

临床试验注册

https://onderzoekmetmensen.nl/en/trial/24150,荷兰试验注册编号NL8469。

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