慢性肾病患者自我管理方案的有效性随机对照试验

　　Effectiveness of self-management program in people with chronic kidney disease: A pragmatic randomized controlled trial

　　慢性肾病患者自我管理方案的有效性：一项实用的随机对照试验

　　ABSTRACT 

　　Aims :

　　To examine the effectiveness of a self-management intervention compared with usual care in adults with chronic kidney disease on self-management, knowledge, self-efficacy, health -related quality of life and blood pressure.

　　Design :

　　A parallel group randomized controlled trial.

　　Methods:

　　Patients aged ≥ 18 years with chronic kidney disease stages 3?5 were recruited between November 2015 - June 2016. Participants were randomly allocated into either the intervention (N = 68) or control group (N = 67). The control group received usual care, while the intervention group received usual care plus a self-management program from a nurse. The intervention was guided by social cognitive theory and included a face -to -face educational session followed by telephone support. Both groups were followed for 16 weeks.

　　Results:

　　There were no significant differences in self-management, knowledge, self-efficacy, health -related quality of life and blood pressure between the two groups at baseline. At week 16, compared with the control group, large effect sizes for improved self-management, knowledge and self-efficacy were detected. For health -related quality of life, the physical and mental health components significantly improved. However, no significant differences in either systolic or diastolic blood pressures were found.

　　Conclusion:

　　In earlier stages of chronic kidney disease, a simple self-management education benefits patients.

　　Impact:

　　Effective self-management in the earlier stages of chronic kidney disease contributes to slowing its progression, improving health outcomes and lowering the burden on healthcare systems. This study demonstrated that social cognitive theory increases chronic kidney disease self-management by strengthening knowledge and self-efficacy. Nurses can provide this education.

　　Keywords: blood pressure, chronic kidney disease, health-related quality of life, knowledge, nurse, randomized controlled trial, self-efficacy, self-management, social cognitive theory.

　　摘要

　　目的：

　　研究成年慢性肾病患者自我管理干预与常规护理相比，在自我管理、知识、自我效能、健康相关的生活质量和血压方面的有效性。

　　设计：

　　平行组随机对照试验。

　　方法：

　　2015年11月至2016年6月期间，招募年龄≥18岁，患慢性肾病3-5期的患者。参与者被随机分配到干预组（N = 68）或对照组（N = 67）。对照组接受常规护理，而干预组接受常规护理和护士提供的自我管理方案。干预以社会认知理论为指导，包括面对面的教育会议，然后再进行电话支持。两组均随访16周。

　　结果：两组患者在基线时自我管理，知识，自我效能，健康相关生活质量和血压无显著差异。在第16周，与对照组相比，自我管理、知识和自我效能的改善效果显著。在健康相关的生活质量方面，生理和心理健康部分得到显著改善。然而，收缩压或舒张压均无显著差异。

　　结论：在慢性肾病的早期阶段，简单的自我管理教育有益于患者。

　　影响：慢性肾病患者早期阶段有效的自我管理，有助于减缓病情发展，改善健康结果并可降低医疗系统的负担。该研究表明，社会认知理论通过强化知识和自我效能来增强慢性肾病患者的自我管理。护理人员便可提供这种教育。

　　关键词：血压 慢性肾病 健康相关生活质量 知识 护理 随机对照试验 自我效能 自我管理 社会认知理论

　　INTRODUCTION

　　Chronic kidney disease (CKD) is a growing health problem worldwide, with approximately 80% of people with CKD living in low to middle income countries (Mills et al., 2016). The global prevalence of CKD in adults is estimated at between 10% to 16% largely due to the rising prevalence of diabetes and hypertension (Dienemann et al., 2016). The disease is classified into stages according to the estimated glomerular filtration rate (eGFR) with stage five also termed end-stage kidney disease (ESKD) when kidney replacement therapy (KRT) is required to sustain life (Webster, Nagler, Morton, & Masson, 2017). Most people with this disease are in stages 3 –5 (Hill et al., 2016). CKD creates a significant impact on the physical health, psychological well-being and social domains of life and it contributes to lower health - related quality of life (HRQoL) (Almutary, Douglas, & Bonner, 2017). Empowering people through providing simple information to improve their knowledge and confidence to better self-manage chronic disease is likely to affect overall health and wellbeing (Jordan & Osborne, 2007) and in CKD is known to slow the disease progression (Lee, Wu, Hsieh, & Tsai, 2016; Lin, Liu, Hsu, & Tsai, 2017; Lopez -Vargas, Tong, Howell, & Craig, 2016).

　　前言

　　慢性肾病（CKD）是世界范围内一个日益严重的健康问题，大约80％的CKD患者生活在中低收入国家。全球成年CKD患病率估计在10％至16％之间，主要是由于糖尿病和高血压的患病率上升。根据估算肾小球滤过率（eGFR）将慢性肾病分为不同的阶段，当需要肾脏替代疗法（KRT）维持生命时，第五阶段也称为终末期肾病（ESKD）。大多数患有这种疾病的人处于3-5期。CKD对身体健康，心理健康和生活的社会领域产生重大影响，导致与健康相关的生活质量（HRQoL）下降。通过提供简单的信息来提高他们的知识和信心，从而对慢性病进行更好地自我管理，很可能会对患者整体健康和福祉有积极影响，并且CKD已知可以被减缓疾病进展。

　　Vietnam is an example of a low income country and it is estimated that six million people have CKD (Hyodo et al., 2017). The healthcare system in this country has an almost non - existent primary healthcare service and, as a consequence, the acute hospital system is severely over-stretched with the growing burden of chronic disease. It is usual in acute hospitals to find 2?3 patients occupying the same bed and outpatient clinics, where people have to return to have medications prescribed, are extremely overcrowded. Hence, slowing the progression of CKD to avoid needing KRT and to reduce the disease burden on society and healthcare systems requires urgent attention in this country.

　　越南是一个典型的低收入国家，估计有600万人患有CKD。这个国家的医疗系统几乎不存在初级医疗服务，因此，由于慢性病负担日益加重，急症医院系统严重超负荷。通常是在急症医院系统看到2-3名患者占据同一床位，在门诊的病人不得不按药方拿药，场面极度拥挤不堪。因此，这个国家迫切需要减缓CKD的病情发展，以避免需要KRT，从而减少社会和医疗系统的负担。

　　Background

　　CKD is usually asymptomatic and often unrecognized until at an advanced stage of kidney failure. The lack of debilitating symptoms may mean that people are less inclined to believe that they have CKD (Braun, Sood, Hogue, Lieberman, & Copley -Merriman, 2012; Picariello, Moss -Morris, Macdougall, & Chilcot, 2017) and could reduce their engagement in selfmanagement behaviour. Providing self-management education is essential to assist people in knowing what CKD is, how to identify early symptoms and how to take steps to manage their disease.

　　背景

　　CKD通常是无症状的，直到肾衰竭晚期才会被发现。患者缺乏明显衰弱的症状，所以他们不太相信自己患有CKD，这也可能会降低他们在自我管理行为中的参与度。提供自我管理教育，对于帮助人们了解CKD是什么，如何识别早期症状以及如何采取措施管理疾病至关重要。

　　There have been five systematic reviews of CKD self-management (Bonner et al., 2014; Lee et al., 2016; Lin et al., 2017; Lopez -Vargas et al., 2016; Welch et al., 2014), although most of the included studies involved participants with ESKD and, specifically, being treated with haemodialysis. In these systematic reviews, there have been eight randomized controlled trials (RCTs) involving 1,011 people with CKD who were not on dialysis (Blakeman et al., 2014; Byrne, Khunti, Stone, Farooqi, & Carr, 2011; Campbell, Ash, & Bauer, 2008; Chen et al., 2011; Flesher et al., 2011; Paes -Barreto et al., 2013; Teng, Yen, Fetzer, Sung, & Hung, 2013; Williams, Manias, Walker, & Gorelik, 2012). Since the systematic reviews have been published there has been one further RCT (Joboshi & Oka, 2016).

　　CKD自我管理已有五次系统评价，虽然纳入研究大多涉及ESKD的参与者，特别是正在接受血液透析治疗。在这些系统评价中，有8项随机对照试验（RCT）涉及1,011名未接受透析的CKD患者。自系统评价发表以来，还有一项随机对照试验。

　　Across the nine studies there was inconsistent use of a framework or theory to inform the interventions; only social cognitive theory (SCT) was used in more than one study (Byrne et al., 2011; Joboshi & Oka, 2016). Briefly, the goal of SCT is to effectively explain and change behaviour. This theory is about how human behaviour is modified by improving a person’s self-efficacy—a belief in their ability to successfully perform that behaviour (Bandura, 1997). While self-efficacy is a central tenet of SCT, it is the outcome of self-efficacy which is important. By having greater confidence in your ability to self-manage a chronic disease, a person is more likely to engage in that behaviour and overtime, health outcomes are likely to improve. In the two previous studies which reported using SCT, (Byrne et al., 2011; Joboshi & Oka, 2016), it was unclear how the components of SCT were used to improve self-efficacy or self-management behaviours. Nevertheless, both of these studies did show that an educational intervention could affect these outcomes in people with CKD.

　　在这9项研究中，没有一致地框架或理论来规范干预措施，只有社会认知理论（SCT）被用于不止一项研究。简而言之，SCT的目标是有效地解释和改变行为。这个理论是关于如何通过提高一个人的自我效能来改变个人行为的——自我效能是一种相信自己有能力成功完成这种行为的信念。虽然自我效能是SCT的核心原则，但是自我效能的结果才是最重要的。通过对自我管理慢性病的能力更有信心，一个人更有可能参与这种行为，从而改善健康结果。在之前使用SCT报告的两项研究中，目前尚不清楚SCT的组成部分如何改善自我效能或自我管理行为。然而，这两项研究都表明，教育干预可能会影响CKD患者的这些结果。

　　The previous studies also differed with regard to the intervention. For example, four studies focused on improving overall CKD knowledge (Blakeman et al., 2014; Byrne et al., 2011; Chen et al., 2011) whereas others specifically focused on diet (Campbell et al., 2008; Chen et al., 2011; Flesher et al., 2011; Joboshi & Oka, 2016). The format of the self-management interventions also varied with the most frequently used format being face -to -face education delivered by nurses (Byrne et al., 2011; Chen et al., 2011; Flesher et al., 2011; Joboshi & Oka, 2016; Williams et al., 2012). The duration of the interventions ranged from 12 weeks (Campbell et al., 2008; Joboshi & Oka, 2016) to twelve months (Chen et al., 2011; Flesher et al., 2011; Teng et al., 2013; Williams et al., 2012). Due to the heterogeneity of the studies, it is not possible to identify the ideal format and duration of a CKD self-management program.

　　以往的研究在干预方面也有所不同。例如，有四项研究侧重于改善CKD知识水平，而其他研究特别关注于饮食。自我管理干预的形式也各不相同，最常用的形式是护士提供面对面的教学。干预的持续时间从12周到12个月不等。由于研究的异质性，无法确定最佳的CKD自我管理项目形式和持续时间。

　　Notably the studies also measured different patient -reported and clinical outcomes. Regarding patient -reported outcomes and although improvement in self-management was the aim in all nine studies, only six studies measured this outcome using six different instruments (Blakeman et al., 2014; Flesher et al., 2011; Joboshi & Oka, 2016; Paes-Barreto et al., 2013; Teng et al., 2013; Williams et al., 2012). Knowledge about CKD was assessed as an outcome in three studies (Blakeman et al., 2014; Chen et al., 2011; Teng et al., 2013). Self-efficacy was measured in only one study (Joboshi & Oka, 2016). Improvement in HRQoL, an indicator of the beneficial effects of improved self-management (Pagels et al., 2012), was assessed in only two studies (Blakeman et al., 2014; Campbell et al., 2008). Nevertheless, across all studies, self-management programs seemed to show benefits in improved patient reported self-management, knowledge, self-efficacy and HRQoL. In regards to clinical outcomes, change in eGFR (Chen et al., 2011; Flesher et al., 2011; Joboshi & Oka, 2016; Paes -Barreto et al., 2013; Williams et al., 2012) and BP (Blakeman et al., 2014; Flesher et al., 2011; Joboshi & Oka, 2016; Williams et al., 2012) were the two most frequently assessed. Overall inconsistent findings were demonstrated for these clinical outcomes.

　　值得注意的是，这些研究还衡量了不同的患者报告和临床结果。关于患者报告的结果，尽管所有9项研究的目标都是改善自我管理，但只有6项研究使用6种不同的工具衡量了这一结果。三项研究将CKD知识作为评估结果。仅有一项研究中测量了自我效能。HRQoL的改善是改善自我管理有益效果的指标，但仅有两项研究中对其进行了评估。然而，在所有研究中，自我管理项目似乎能够改善病人自我管理报告、知识、自我效能和HRQoL。在临床结果方面，eGFR的变化和BP是最常见的两种评估。但这些临床结果的总体结果不一致。

　　In summary, the existing evidence for practice is weak because the previous studies have methodological limitations and, due to heterogeneity of methods and outcomes, a meta -analysis is not possible. This study seeks to avoid these limitations and to contribute to the evidence-base by robustly using a behavioural change theory, SCT, to inform a CKD self-management intervention which is simple and inexpensive to deliver. Its effectiveness will be determined by using person-centred outcome measures (PROMs) which align with SCT (i.e. knowledge, self-efficacy, self-management behaviour and HRQoL). Figure 1 presents the theoretical framework of the study .

　　总之，现有的实践证据很不充足，因为之前的研究具有方法上的局限性，并且由于方法和结果的异质性，而不能进行系统评价。本研究为了避免这些局限性并提供更多证据支持，通过使用社会认知理论来干预CKD自我管理，这种干预简单且成本低廉。研究的有效性将通过使用与SCT一致的以人为中心的结局估量（PROMs）（即知识，自我效能，自我管理行为和HRQoL）来确定。图1表示了该研究的理论框架。

　　THE STUDY

　　Aims

　　The aim of the study was to examine the effectiveness of a self-management intervention compared with usual care in improving self-management behaviour, knowledge, selfefficacy, HRQoL and BP in adults with CKD stages 3?5.

　　研究 

　　目标

　　该研究的目的是检查自我管理干预与常规护理相比，在改善CKD 3-5期成人的自我管理行为、知识、自我效能、HRQoL和BP方面的有效性。

　　Hypotheses

　　The study hypothesized that participants in the intervention group will have: (1) greater selfmanagement behaviour, knowledge, self-efficacy, HRQoL than those in the control group; and (2) lower systolic and diastolic blood pressure compared with the control group.

　　假设

　　该研究假设干预组将会：（1）比对照组有更好的自我管理行为、知识，自我效能、HRQoL;（2）收缩压和舒张压低于对照组。

　　Design

　　The study design was a single-blind pragmatic randomized controlled trial (pRCT) with one - to -one allocation into two parallel groups with repeated measures. A pRCT enables a broader range of patients to be included in an intervention, thus enhancing external validity and the translation of results into clinical care (de Boer et al., 2016; Saturni et al., 2014).

　　设计

　　该研究设计是一项单盲实用随机对照试验（pRCT），其中一对一分配为两个平行组，并进行重复测量。pRCT可使更广泛的患者纳入干预，从而增强外部有效性，并将结果转化为临床护理。

　　Participants and setting

　　Participants were recruited from renal outpatient clinics at a large general hospital in Hanoi, Vietnam from November 2015 to June 2016. The inclusion criteria were aged ≥ 18 years, with a medical diagnosis of CKD stages 3?5 and not receiving dialysis, able to communicate in Vietnamese, contactable by phone and willing to consent to participate. Participants were excluded if they had cognitive impairment or were seriously unwell (both determined by a medical practitioner) or were enrolled in another trial.

　　参与者和设置

　　2015年11月至2016年6月，在越南河内的一家大型综合医院的肾科门诊招募参与者。招募标准为年龄≥18岁，医学诊断为CKD 3-5期且未接受透析，能够用越南语沟通，可通过电话联系并同意参加。如参与者有认知障碍、严重不适（由医生确定）或参加了另一项试验，则将其剔除。

　　Intervention

　　Control group

　　Participants randomized to the control group received usual CKD care provided by renal medical practitioners and nurses at the outpatient clinic. Usual care consisted of brief verbal information (2 -5 minutes) about taking medications, reducing salt, smoking cessation and reducing alcohol consumption. There was no structured program or the provision of written material to patients.

　　干预

　　对照组

　　被随机分配到对照组的参与者在门诊接受了肾脏医生和护士提供的常规CKD护理。常规护理包括关于服用药物，减少盐分，戒烟和减少饮酒的简短口头信息（2-5分钟）。没有结构化的程序或向患者提供书面材料。

　　Intervention group

　　Participants assigned to the intervention group received both usual CKD care and a 12 -week self-management intervention delivered by the first author who is an experienced nurse teacher. The intervention involved a CKD booklet and a handout, one face -to -face session and two brief follow-up sessions. The face -to -face session was provided in a private room at the renal clinic on an individual basis, while the follow -up sessions were undertaken by phone. The CKD self-management program is presented in Table 1.

　　干预组

　　干预组的参与者接受了常规CKD护理和由第一作者（一名经验丰富的护士老师）提供的为期12周的自我管理干预。干预包括CKD手册和讲义，一次面对面会话和两次简短的跟进会话。面对面会话是在肾脏诊所的私人房间内单独进行的，而跟进会话则使用电话进行。CKD自我管理计划如表1所示。

　　The CKD booklet was translated and adapted by the first author with permission from Living with Reduced Kidney Function handbook (Kidney Health Australia, 2008) and Living Well with Chronic Kidney Disease handbook (American Kidney Fund, 2010); both of these booklets are suitable for people with low literacy skills. The Vietnamese CKD booklet explained the function of the kidneys, the early signs and symptoms of CKD and strategies for managing or delaying the progression of CKD, such as the benefits of maintaining a healthy lifestyle and adherence to medications. It also contained a diary for participants to record and monitor their clinical data, treatment plan and questions for medical appointments. Prior to the study, a nephrologist checked the content for accuracy. The handout summarized the main points in the CKD booklet and important self-management skills such as taking medications, nutrition and exercise, smoking cessation, understanding renal clinical results and using available resources to self-manage CKD.

　　CKD手册由第一作者翻译改编，并获得了《Living with Reduced Kidney Function handbook》和《Living Well with Chronic Kidney Disease》手册的许可，这两本手册都适合阅读能力低的人。越南CKD手册解释了肾脏的功能，慢性肾病的早期症状和体征，以及管理或延缓慢性肾病进展的方法，例如保持健康的生活方式和坚持服用药物的好处。它还包含一份日记，供参与者记录和监测他们的临床数据、治疗计划和预约医疗的问题。在这项研究之前，肾病学家检查了手册内容的准确性。讲义总结了CKD手册的主要内容和自我管理技巧重点，如服用药物，营养和运动，戒烟，了解肾脏临床指标和利用现有资源自我管理CKD。

　　The intervention started with a 1 -hour face-to-face session, focused on improving CKD knowledge and self-management by u sing the four self-efficacy information sources. In SCT, self-efficacy can be improved through performance accomplishment, vicarious experience, verbal persuasion and self-appraisal as strategies to support self-management behaviour (Bandura, 1997). Performance accomplishment is the confidence that comes from within a person when they feel a sense of success, particularly if they believe that they have mastered that behaviour (Bandura, 1997 ). Performance accomplishment is the most important strategy to assist participants to actually engage in performing self-management behaviour (Bandura, 1997). Participants were asked to identify CKD -related problems and set two realistic achievable goals based on their priorities. These goals were recorded in their CKD booklet and monitored at each follow-up. Vicarious experience can increase self-efficacy through observation of people similar to oneself successfully performing a task (Bandura, 1997). In Vietnam peer learning through vicarious experience in renal clinics is not common. We developed written scenarios of people who successfully overcome challenges to self-manage their kidney problems, using local images and pictures throughout the CKD booklet. Verbal persuasion was used to enhance self-efficacy and support participants to start taking action.

　　干预始于1小时的面对面会话，重点是通过使用四种自我效能信息来源来提高CKD知识和自我管理。在SCT中，通过执行成就，替代经验，言语说服和自我评价作为支持自我管理行为的策略，提高自我效能感。执行成就是一个人在感到成功时产生的信心，尤其是当他们认为自己已经掌握了这种行为时。执行成就是帮助参与者实际参与自我管理行为的最重要方式。要求参与者确定自身与CKD相关的问题，并根据他们的优先级设定两个切实可行的目标。这些目标记录在他们的CKD手册中，并在每次随访时进行监测。替代经验即是通过观察与自己相似的人成功完成一项任务，可以获得更多的自我效能感。在越南，通过肾脏诊所的替代经验进行学习并不多见。我们在CKD手册中，利用本地图像和图片，开发了成功克服问题并进行肾病自我管理的人的书面情景。采用言语说服来提高自我效能，鼓励参与者开始采取行动。

　　Self-appraisal was used to encourage participants to identify where they were succeeding with self-management such as adhering to medications and also to express their concerns or difficulties in managing CKD, for instance struggling with reducing salt in their diet. Participants were then supported to identify possible solutions to achieve their goals.

　　使用自我评价的方法，鼓励参与者确认他们在自我管理方面额成功之处，例如坚持服药。同时也表达他们在管理CKD方面的顾虑或困难，例如在饮食中努力减少盐的摄入。然后，鼓励参与者确定有助于实现目标的解决方案。

　　Participants received two follow-up phone calls of 20?30 minutes at weeks 4 and 12 by the nurse to reinforce the self-management action plan and to review progress towards goals. The focus was to identify improvements and to encourage participants to continue behaviour change through positive reinforcement. Structured around the CKD booklet topics, the discussion supported participants to build on small changes and to use problem-solving skills to overcome daily challenges. Participants were encouraged to use the booklet at home. At the completion of the study, participants in the control group were provided with the CKD booklet.

　　参与者在第4周和第12周接受了两次20-30分钟的后续电话，由护士加强其自我管理行动计划并审查他们的目标进展情况。电话回访重点是找到改进之处，并鼓励参与者通过积极强化继续改变行为。围绕CKD手册主题，回访鼓励参与者以小的变化为基础，使用解决问题的技巧来克服日常挑战。并鼓励参与者在家中使用这本小册子。在研究结束时，对照组的参与者也获得了CKD手册。

　　Outcome measures

　　Primary outcomes

　　The primary outcome was CKD self-management. The original Chronic Kidney Disease SelfManagement (CKD-SM) instrument comprises 29 items (Lin, Wu, Wu, Chen, & Chang, 2012) and it was modified with permission from the instrument developer. Three items were added, including one item about medication [I take my medications even when I am not at home] and two items about problem-solving [I take action when my early warning signs and symptoms get worse; When I have questions about my kidney disease, I discuss what to do with my doctors or nurses]. These three items were added because the original CKD -SM instrument did not include these aspects of self-management. Therefore, a 32 -item CKD -SM instrument was used to measure self-management behaviour factors, including self-integration, problem-solving, seeking social support and adherence to recommended regimen (Lin et al., 2012). Each item is scored on a Likert scale from 1?4 with 1 being ‘never’ and 4 ‘always’. Total scores of the CKD -SM range from 32 to 128 and higher scores indicate a greater level of sel f-management behaviour in managing CKD.

　　结果测量

　　主要成果

　　主要结果是CKD自我管理。原慢性肾病自我管理（CKD-SM）工具包括29项，我们经工具开发者许可进行了修改，添加了三项内容，其中一项是关于药物治疗的（即使我不在家也会服药）和另两项是关于解决问题的（当我有预警信号和症状恶化时我会采取行动;当我对我的肾脏疾病有疑问时，我会和我的医生或护士讨论该怎么做）。增加这三项内容是因为最初的CKD-SM工具没有包括这些自我管理方面。因此，使用32项CKD-SM工具来衡量自我管理行为因素，包括自我整合，解决问题，寻求社会支持和坚持推荐的治疗方案（Lin et al。，2012）。每个项目使用李克特量表进行评分，评分范围为1-4，其中1分为“从不”，4分为“总是”。CKD-SM的总分在32到128之间，分数越高，说明CKD的自我管理行为水平越高。

　　Another primary outcome was kidney disease knowledge. The Kidney Disease Knowledge Survey (KiKS) consists of 28 items that measures the participants’ knowledge related to kidney disease management, such as kidney function, treatment options for kidney failure, signs and symptoms of disease progression, potential medications that harm or benefit the kidney, BP targets and other information related to preserving kidney function (Wright, Wallston, Elasy, Ikizler, & Cavanaugh, 2011). Each item is scored as 1 for a correct response, or 0 for an incorrect response. Total scores of the KiKS range from 0 to 28 and higher scores indicate better understanding of kidney disease.

　　另一个主要结果是肾病知识。肾病知识调查（KiKS）由28个项目组成，用于衡量参与者的肾病知识，如肾功能、肾功能衰竭的治疗方案、疾病进展的迹象和症状、潜在的药物伤害/获益、BP目标和其他与保持肾功能有关的信息。每个项目评分为1代表正确答案，评分为0代表错误答案。KiKS的总分在0到28之间，得分越高，表明对肾病知识的认识越好。

　　Both the CKD -SM instrument and KiKS have been shown to be valid and reliable in previous studies in people with CKD (Anaya et al., 2016; Lin et al., 2012; Wembenyui, 2017; Wright et al., 2011). Permission was sought from both instrument developers prior to translating into Vietnamese. We followed the translation process developed by Sousa and Rojjanasrirat (2011) whereby two bilingual healthcare professionals independently translated both instruments from English to Vietnamese (forward -translation). Then two new bilingual healthcare professionals independently translated the instruments from Vietnamese to English (backward -translation). Both versions were then compared by the authors. No changes were required at this point. Then both the Vietnamese versions of the CKD -SM and KiKS were validated by an expert panel of ten members and tested for reliability in a CKD sample in Vietnam in a previous study (de-identified for review). In this study, the reliability of the CKD -SM was ɑ =0.87 and the KiKS Kuder -Richardson -20 was 0.57.

　　在既往CKD患者的研究中，CKD-SM工具和KiKS被证明是有效和可靠的。在翻译成越南语之前，都征求了两家开发人员的许可。我们遵循了Sousa和Rojjanasrirat（2011）开发的翻译流程，其中两位双语医疗护理专业人员，分别将这两种工具从英语翻译成越南语（正向翻译）。然后，两位新的双语医疗护理专业人员，又将这两种工具从越南语翻译成英语（反向翻译）。然后作者对这两个版本进行了比较，此时不需要更改。然后，越南版本的CKD-SM和KiKS由十名成员组成的专家小组进行了验证，并对CKD样本进行了信度检验。在这项研究中，CKD-SM的信度为ɑ= 0.87，KiKS库德理查森-20信度为0.57。

　　Secondary outcomes

　　The Self-efficacy for Managing Chronic Disease (SECD) measures the level of confidence with undertaking a range of chronic disease -related activities and is widely used in chronic disease studies (Lorig, Sobel, Ritter, Laurent, & Hobbs, 2001). The SECD contains six items and each item scores from 1 to 10 with higher scores indicate greater levels of self-efficacy. The SECD was translated by two bilingual Masters qualified nurses using an independent forward and backwards process similar to above. The reliability of the SECD in this study was ɑ = .92.

　　次要结果

　　慢性病管理的自我效能（SECD）广泛应用于慢性病研究，它衡量的是进行一系列与慢性疾病相关活动的信心水平。SECD包含6个项目，每个项目得分从1到10，得分越高表示自我效能水平越高。SECD由两位合格的双语护理硕士翻译，采用类似于上述的独立正向和反向翻译。本研究中SECD的信度为ɑ= 0.92。

　　The SF-36v2 measures participants’ perceptions of HRQoL (McHorney, Ware, & Raczek, 1993) and has been extensively used in CKD populations. The SF -36v2 is available in Vietnamese language (Bullinger et al., 1998; Ware et al., 2008) and the Cronbach’s alpha in this sample for the physical component (PCS) and mental component (MCS) summary subscales were .85 and .87, respectively.

　　SF-36v2量表广泛应用于CKD人群，在此研究中用以衡量参与者对HRQoL的感知。SF-36v2采用越南语版本，该样本中物理成分（PCS）和心理成分（MCS）组成的分量表克朗巴赫系数分别为.85和.87。

　　A manual BP cuff was used to measure BP at each clinic appointment and recorded in the medical record. Both systolic pressure (SBP) and diastolic pressure (DBP) in mmHg were obtained.

　　每个门诊使用手动血压袖带测量血压，并记录在病历中。分别测定以mmHg为计量单位的收缩压（SBP）和舒张压（DBP）。

　　Additionally, participants’ demographic and renal clinical characteristics were obtained at baseline. Demographic characteristics were age, gender, marital status, level of education and occupation. Renal clinical characteristics were eGFR, comorbidities, medications, time diagnosed with CKD and body mass index (BMI) with all extracted from patients’ medical records. The CKD -EPI formula (National Kidney Foundation, 2015) was used to calculate eGFR for each participant using age, gender and serum creatinine level, which was then used to classify participant’s stage of CKD. A list of chronic diseases was collected to enable the Charlson comorbidity index (CCI) to be calculated (Quan et al., 2011). The CCI is classified into three levels: mild (score of 1 –2), moderate (score of 3 –4) and severe comorbidity (scores ≥ 5).

　　此外，在基线时获得参与者的人口统计学和肾脏临床特征。人口统计学特征包括年龄、性别、婚姻状况、教育程度和职业。肾脏临床特征为eGFR，共病，使用药物，CKD诊断时间和体重指数（BMI），数据均取自于患者病历。使用CKD-EPI公式，通过参年龄，性别和血清肌酐水平计算参与者的eGFR，然后将其用于对CKD参与者的阶段进行分类。收集慢性病列表以计算Charlson共病指数（CCI）。CCI分为三个级别：轻度（1-2分），中度（3-4分）和严重并发症（分数≥ 5).

　　Sample size calculation

　　This study aimed to improve participants’ self-management behaviour. The sample size was calculated assuming 80% power (1 -beta = .8), a type 1 error rate (alpha) of .05 (two -tailed) and a medium effect size (Cohen’s d = 0.5) on improved self-management reported by Bonner et al. (2014) in other CKD studies where participants were not receiving dialysis. A minimum of 134 participants (67 per group) were required.

　　样本量计算

　　本研究旨在改善参与者的自我管理行为。Bonneret 等人在其他CKD研究中报道，在参与者未接受透析的情况下，样本量的计算假设为80%的把握度(1 -beta = .8)、0.05的Ⅰ型错误率(alpha)(双尾)和中等效应(Cohen’s d = 0.5)来改善自我管理。至少需要134名参与者（每组67人）。

　　Randomization

　　A random -number table was generated in Microsoft Excel to produce an allocation sequence for the control and intervention groups. A number was placed inside an opaque sealed envelope according to the random -number table. All sealed envelopes were then mixed and placed into a box. After baseline data was collected, each participant selected an envelope. Allocation concealment was achieved with a trained recruitment research assistant assessing for eligibility, conducting recruitment, collecting baseline data and supervising participants selecting an envelope. The recruitment research assistant then used the coding sheet to randomly allocate participants into either the control or intervention group.

　　随机化

　　在Microsoft Excel中生成一个随机数字表，为对照组和干预组的安排顺序。根据随机数字表，将每个数字放在一个不透明的密封信封内，然后将所有密封的信封混合并放入一个盒子中。在收集基线数据后，每个参与者选择一个信封。通过招募一名训练有素的研究助理，来评估合格性、进行招聘、收集基线数据和监督参与者选择信封，从而实现了分组隐藏。然后，研究助理使用随机数字表将参与者随机分配到对照组或干预组。

　　Blinding

　　To minimize bias, participants and the recruitment research assistant were blinded until allocation. The outcome research assistant did not have access to the coding sheet or the interpretation of the code, was therefore blinded to group allocation.

　　盲法

　　为了尽量减少偏见，参与者和招募的研究助理在分配之前均不知情。研究助理无法获悉编码表或对编码的解释，因此对分组不知情。

　　Procedure

　　Recruitment flyers were given to potential eligible participants by renal nurses on arrival to the outpatient clinic. Due to the very long waiting time, often 3?4 hours in clinics, the recruitment research assistant could provide a written information sheet, verbally explain the study and answer questions and obtain consent. Then baseline data and random group allocation occurred. The recruitment research assistant then referred participants in the intervention group to the nurse who delivered the 1 -hour teaching session. At weeks 4 and 12, a 20?30 minutes telephone self-management follow -up occurred. The outcome research assistant collected repeated measures in the outpatient clinic or via telephone. The CKD -SM, KiKS and SECD were measured at baseline, weeks 8 and 16. HRQoL and BP were measured at baseline and week 16.

　　过程

　　肾脏护士在到达门诊时，向潜在的合格参与者发放招募传单。由于需等待很长的时间，通常在诊所3-4小时，招聘的研究助理可以提供一份书面信息表，口头解释这项研究，回答他们的问题以致获得同意。然后采集基线数据和随机组分配。然后，研究助理将干预组的参与者介绍给护士，为其提供1小时教学会话。在第4周和第12周，进行了20-30分钟的电话跟进，了解患者自我管理状况。研究助理在门诊或通过电话收集重复测量的数据。在基线，第8周和第16周测量CKD-SM，KiKS和SECD。在基线和第16周测量HRQoL和BP。

　　Validity and reliability

　　To enhance validity and reliability of the data, measurements with good psychometric properties were used to assess the study outcomes. The psychometric properties of the CKD - SM, KiKS, SECD and HRQoL have been shown to be acceptable in previous studies (Anaya et al., 2016; Freund et al., 2013; Hu, Gruber, & Hsueh, 2010; Lin et al., 2012). All eligible participants were randomly allocated to the control or intervention group and included in the data analysis using intention -to -treat (Hoffmann, Bennett, & Del Mar, 2017). The study was conducted and reported in accordance with the CONSORT 2010 Statement (Moher et al., 2010).

　　效度和信度

　　为了提高数据的效度和信度，采用具有良好心理测量特性的测量方法对研究结果进行评估。CKD-SM，KiKS，SECD和HRQoL的心理测量特性，在以前的研究中已被证明是合理的。所有符合条件的参与者被随机分配到对照组或干预组，并使用意向性治疗分析。该研究是根据CONSORT 2010声明进行和报告的。

　　Ethical considerations

　　The study was approved by the (de -identified university) Human Research Ethics Committee and the hospital in which the study was conducted (Approval No. 1500000678). Potential participants were given a verbal explanation of the study and provided with an information sheet prior to consenting. Participants were assured that they had the right to refuse to participate or to withdraw from the study at any time and if they refused or withdrew from the study there would be no effect on the healthcare they received. Confidentiality was assured and no personal information was disclosed to any other person. All data were stored in a secure area and only u sed for the purpose of the study. The results were reported as group data and no names or other forms of identity were disclosed.

　　伦理学问题

　　该研究得到（未指明的大学）人类研究伦理审查委员会和进行该研究所在医院（批准号1500000678）的批准。在同意之前，潜在参与者被给予对该研究的口头解释，并提供了一份信息表。研究人员向参与者保证，他们有权随时拒绝参加或退出研究，如果他们拒绝或退出研究，他们所获得的医疗服务不受影响。并保证了研究的保密性，没有向任何其他人透露任何个人信息。所有数据均存储在安全位置，仅用于研究目的。结果以组数据形式展示，未披露姓名或其他形式的身份特征。

　　Data analysis

　　Data were entered into IBM SPSS Statistics version 22 (IBM Corporation, NY, USA) and an intention-to-treat analysis was performed. Missing data was not replaced , and outcomes were normally distributed. Baseline characteristics for control and intervention groups were compared. Linear mixed models were used to evaluate the effects of the intervention on primary and secondary outcomes. Group, time and group × time were included in each of the models as fixed effects. To account for correlation between patients’ repeated measures over time, patient-level random effects were also included in each model. The group × time interaction was examined to determine the overall treatment effects between groups over time. Outcome variables were assessed prior to testing. Residuals were normally distributed, had a mean of zero and had a constant variance (Tabachnick & Fidell, 2013) . Cohen’s d effect size was used to calculate the magnitude of the treatment effect of the intervention group compared wit h the control group at each time point using the pooled standard deviation (SDpooled ). Values of Cohen’s d are small, medium and large effect (0.2, 0.5 and 0.8, respectively; Cohen, 1988) .

　　数据分析

　　将数据输入IBM SPSS Statistics版本22（IBM Corporation，NY，USA）并进行意向治疗分析。丢失的数据没有被替换，结果呈正态分布。比较对照组和干预组的基线特征。采用线性混合模型评价干预对主要和次要结果的影响。组、时间和组×时间在每个模型中作为固定效应。为了解释患者的重复测量值随时间的相关性，每个模型中还包括患者水平的随机效应。检查组×时间相互作用以确定组间随时间的总体治疗效果。在测试之前评估结果变量。残差为正态分布，均值为零并且方差恒定。使用合并的标准偏差，使用Cohen’s d效应量来计算干预组与对照组相比在每个时间点的治疗效果的大小。Cohen’s d的值是小，中，大效应（分别为0.2,0.5和0.8; Cohen，1988）。

　　RESULTS

　　Participant flow

　　A total of 148 people were assessed for eligibility and of these 135 agreed to participate in the study with 67 allocated into the control group and 68 in the intervention group. At week 8, the intervention and control groups had lost two participants each and by week 16, the control group had lost six participants and the intervention group had lost five participants. Figure 2 depicts the study flow of participants.

　　结果 

　　研究对象变化

　　共有148人接受了资格评估，其中135人同意参与该研究，其中67人分配到对照组，68人分配到干预组。在第8周，干预组和对照组各减少了两名参与者，到第16周，对照组减少了6名参与者，干预组减少了5名参与者。图2描述了研究对象的流向。

　　Demographic and renal clinical characteristics

　　Participants’ demographic and renal clinical characteristics are reported in Table 2. Ages of ranged from 22 to 80 years old with a mean age of 48.9 (SD 13.8). Half of the participants were female (67/135). Most participants were in either CKD stages 3B (48/135) or 4 (43/135). There were no differences in demographic and renal clinical characteristics between the two groups at baseline.

　　人口统计学和肾脏临床特征 

　　参与者的人口统计学和肾脏临床特征见表2.年龄范围为22至80岁，平均年龄为48.9（标准差13.8）。有一半的参与者是女性（67/135）。大多数参与者处于CKD第3B期（48/135）或第4期（43/135）。在基线时，两组间的人口统计学和肾脏临床特征无差异。

　　Effects of self-management program on study outcomes

　　Table 3 presents the primary and secondary outcomes at each time point.

　　自我管理项目对研究结果的影响

　　表3列出了每个时间点的主要和次要结果。

　　Primary outcomes

　　Linear mixed models were used to examine the change in self-management and knowledge at each time point (see Table 3). Overall the effect of the intervention on self-management behaviour between groups over time was significant ( F = 178.84, p < .001). Figure 3A shows that although there was no difference in mean scores for self-management at baseline, there was a large improvement in the intervention group by week 8 (mean difference = 12.44, 95% Confidence Intervals [CI] = 7.48?17.40, d = 0.84 ) and a further improvement by week 16 (mean difference = 18.13, 95% CI = 13.14?23.11, d = 1.25). Compared with the control group, participants in the intervention group also had improvements in kidney disease knowledge over time (F = 226.89, p < .001). Figure 3B shows that while knowledge scores were similar at baseline and remained stable in the control group, there was a large improvement in the intervention group by week 8 (mean difference = 5.71, 95% CI = 4.80?6.62, d = 2.15 ) and sustained improvement by week 16 (mean difference = 7.43, 95% CI = 6.50?8.36, d = 2.86).

　　主要成果

　　采用线性混合模型检测每个时间点自我管理和知识的变化（见表3）。总体而言，干预对组间自我管理行为的影响是显著的（F = 178.84，p <.001）。表3A显示，尽管基线时自我管理的平均得分没有差异，但干预组在第8周时有很大改善（平均差= 12.44,95％置信区间[CI] = 7.48-17.40，并在第16周有进一步改善（平均差= 18.13,95％CI = 13.14-23.11，d = 1.25）。与对照组相比，干预组的参与者肾病知识随着时间的推移也有改善（F = 226.89，p <.001）。表3B显示虽然知识得分在基线时相似，并且在对照组中保持稳定，但干预组在第8周时有很大改善（平均差= 5.71,95％CI = 4.80-6.62，d = 2.15）第16周有持续改善（平均差= 7.43,95％）CI = 6.50-8.36，d = 2.86）。

　　Secondary outcomes

　　Similar mixed models were used to examine the change in participants’ self-efficacy, HRQoL, SBP and DBP (Table 3). The overall intervention effect on self-efficacy between groups over time was significant ( F = 40.81, p < .001). Figure 3C shows that there was no difference in self-efficacy scores at baseline, which remained unchanged in the control group over weeks 8 and 16. By contrast, the intervention group had increased in self-efficacy scores at week 8 (mean difference = 1.02, 95% CI = 0.49?1.55, d = 0.64) and a larger increase after 16 weeks (mean difference = 1.43, 95% CI = 0.90?1.96, d = 0.96). Figures 3D and 3E display that there were no differences in mean scores for HRQoL at baseline . However, at 16 weeks compared with the control group, the intervention group reported improved HRQoL with medium effect sizes for both PCS (mean difference = 6.91, 95% CI = 1.22?12.60, d = 0.72) and MCS (mean difference = 7.83, 95% CI = 1.88?13.78, d = 0.59). Figures 3F and 3G show that there were no change found between groups over time for SBP ( F = 1.15, p = .28) and DBP (F = 0.19, p = .66).

　　次要结果

　　采用相似的混合模型检测参与者的自我效能、HRQoL、SBP和DBP的变化（表3）。随着时间的推移，干预组自我效能的总体干预效果显著（F = 40.81，p <.001）。表3C显示，在基线时自我效能评分没有差异，在第8周和第16周时对照组评分没有变化。相比之下，干预组在第8周的自我效能评分增加（平均差= 1.02） ，95％CI = 0.49-1.55，d = 0.64）并且在16周后增加幅度更大（平均差= 1.43,95％CI = 0.90-1.96，d = 0.96）。表3D和表3E显示HRQoL在基线时的平均得分没有差异。然而，与对照组相比，干预组在16周时改善了HRQoL，PCS（平均差= 6.91,95％CI = 1.22-12.60，d = 0.72）和MCS（平均差= 7.83， 95％CI = 1.88-13.78，d = 0.59）。表3F和3G显示，SBP（F = 1.15，p = .28）和DBP（F = 0.19，p = .66），两组随时间没有发现变化。

　　Adverse events

　　No intervention -related adverse events were observed during the study period.

　　不良事件

　　在研究期间未观察到与干预相关的不良事件。

　　DISCUSSION

　　This study demonstrated that a self-management intervention guided by SCT improved selfmanagement behaviour, knowledge, self-efficacy and HRQoL in patients with CKD stages 3?5. Compared with the control group, the intervention group showed large improvements in self-management behaviour, knowledge and self-efficacy. Physical and mental health improvements were also detected after 16 weeks. The effect on BP, however, was not demonstrated during the study period .

　　讨论

　　本研究表明，SCT指导的自我管理干预改善了CKD 3-5期患者的自我管理行为、知识、自我效能和HRQoL。与对照组相比，干预组在自我管理行为、知识和自我效能方面有显著改善。健康状况在16周后也得到了改善。然而，在研究中没有发现对血压有影响。

　　The effectiveness of the self-management intervention on the study outcomes is consistent with SCT. The intervention group pattern of findings showed increases in participants’ knowledge and self-efficacy which translated into improved self-management behaviour and HRQoL. Behaviour modification theories such as SCT to inform clinical care are crucial. We found a large improvement in self-efficacy in the intervention group indicating that these participants believed in their ability to take action. As few CKD interventions have been informed by theories and that important PROMs have not always been reported (Bonner et al., 2014; Welch et al., 2014), this study provides evidence for theory -guided clinical practice in CKD.

　　本项研究中自我管理干预对研究结果的影响与SCT一致。干预组的研究结果显示，参与者的知识和自我效能有所提高，这转化为改善自我管理行为和HRQoL。行为改造理论，如SCT，为临床护理提供了至关重要的信息。我们发现干预组的自我效能有很大改善，表明这些参与者相信自己有能力采取行动。由于理论所知的CKD干预措施很少，且并未总是报道重要的PROMs，因此本研究为CKD理论指导临床实践提供了依据。

　　Knowledge is a precondition for behaviour change and in our study the intervention group showed a large improvement in kidney disease knowledge. Improvement in kidney disease - related knowledge is integral to self-management behaviour because people need to have sufficient understanding of the disease to take action to self-manage (Havas, Douglas, & Bonner, 2017; Narva, Norton, & Boulware, 2015) . We also found a large improvement in self-management behaviour compared with the control group after 16 weeks indicating that improvement in behaviour is achievable when knowledge and confidence (i.e. self-efficacy) are also part of the self-management program. Setting realistic and achievable goals together with follow -up support on the phone may have also contributed to building self-confidence to do the everyday tasks to self-manage CKD.

　　知识是行为改变的前提，在我们的研究中，干预组在肾病知识方面有了大幅改善。提高肾病患者相关知识水平，是自我管理行为不可或缺的重要因素。因为，人们需要对疾病有足够的了解，才能采取行动进行自我管理的行动。我们还发现，与对照组相比，16周后自我管理行为有了很大改善，这表明，当知识和信心（即自我效能）也是自我管理计划的一部分时，行为的改善是可以实现的。设置现实可行的目标以及电话的跟进支持，可能也有助于建立自信，来完成日常任务以便自我管理CKD。

　　Changes in HRQoL reflect how patients are able to self-manage CKD to achieve overall well -being and it can serve as an important indicator to evaluate the effectiveness of selfmanagement interventions (Wyld, Chadban, & Morton, 2016). After 16 weeks, the improvement in both the physical and mental health component scores in this study indicated that the intervention group had better HRQoL compared with the control group. This is an important finding as CKD is often asymptomatic due to the long, slow decline in renal function and people do adapt to this slow change and the effects on their life. Response shift (Howard, Mattacola, Howell, & Lattermann, 2011) may mask the treatment impact of selfmanagement on HRQoL although, given that our study was only 16 weeks, the improvement seen in HRQoL was probably real.

　　HRQoL的变化，反映了患者如何能够自我管理CKD以实现整体幸福感，并且，它可以作为评估自我管理干预效果的重要指标。16周后，本研究中生理和心理健康得分的提高，表明干预组与对照组相比具有更好的HRQoL。这是一个重要的发现，因为CKD通常是无症状的，因为肾功能长期缓慢下降，人们会适应这种缓慢的变化及其对生命的影响。反应转移可能掩盖了自我管理对HRQoL的治疗影响，尽管我们的研究只有16周，但HRQoL的改善可能是真实的。

　　We did not find any change in BP in the intervention group and this finding is similar to other studies (Flesher et al., 2011; Joboshi & Oka, 2016; Williams et al., 2012). In the context of CKD, people may need longer than 16 weeks to develop selfmanagement habits to control BP. Nevertheless, good BP control is an important outcome of improved self-efficacy and changed behaviour.

　　我们在干预组中没有发现血压有任何变化，这一发现与其他研究一致。在慢性肾病的情况下，人们可能需要超过16周的时间，才能养成控制血压的自我管理习惯。然而，良好的血压控制是提高自我效能和改变行为的重要结果。

　　Self-management of CKD requires food management, BP management, blood result management and medication management (Ong, Jassal, Porter, Logan, & Miller, 2013). Each of these tasks is shaped by the culture and context in which they occur. The Vietnamese culture is strongly influenced by familial relationships and people often live in extended, multigenerational families (Van, Duangpaeng, Deenan, & Bonner, 2012). Self-management is not only an individual issue, but should be considered in the broader family context, where the family is often involved in supporting and creating a good environment that helps in maintaining everyday activities to manage CKD (Chen et al., 2018). For example, families often provide support to their family member who has CKD to eat the correct food and to take their medication. The support from family members is an important aspect in each individual’s disease management (Hoang, Green & Bonner, 2018); therefore, healthcare providers should recognize this and include family members in self-management education sessions (Thirsk & Clark, 2014). Further research is needed about the role of family members in supporting CKD self-management.

　　CKD的自我管理需要食品管理，BP管理，血液结果管理和药物管理。这些条目中的每一项都由它们发生的文化和环境决定。家庭关系强烈影响越南文化，人们常常生活在多代同堂的家庭中。自我管理不仅是一个个人问题，而且应该在更广泛的家庭背景下加以考虑，因为家庭经常参与支持和创造一个良好的环境，帮助维持日常活动来管理CKD。例如，家庭经常为患有CKD的家庭成员提供支持，以便食用正确的食物和服用药物。家庭成员支持是个体疾病管理的一个重要方面。因此，医疗保健提供者应该认识到这一点，并将家庭成员纳入自我管理教育会话中。家庭成员在支持CKD自我管理方面的作用需要做进一步的研究。

　　Limitations

　　There are some limitations to this study. First, this study attempted to blind outcome evaluators to group allocation although it was not always possible because some participants receiving the intervention disclosed their allocation to the outcome research assistant. Second, the Vietnamese version of the KiKS demonstrated low reliability although this may have been due to the variability of CKD knowledge in this sample. This instrument requires further testing in this target population. Finally, the duration of the study may have been too short and the sample size too small to capture the intervention effects on clinical outcomes such as BP and eGFR.

　　限制

　　这项研究有一定的局限性。首先，本研究试图对结果评估者进行分组，但并不总是可行的，因为一些接受干预的参与者向结果研究助理透漏了他们的分配。其次，越南版的KiKS表现出较低的信度，尽管这可能是由于该样本中CKD知识的可变性。需要使用该工具对这个目标人群作进一步测试。最后，研究的持续时间可能太短，样本量太小，无法确定干预对BP和eGFR等临床结果的影响。

　　CONCLUSION

　　The self-management program was found to be an effective and simple approach to engage people with CKD in developing knowledge, confidenc e and skills to manage their illness. This approach has also shown that nurses can provide self-management education in busy outpatient clinics. The study has significant implications which can inform the development and application of self-management programs in clinical practice, in healthcare for chronic disease and for the role of the nurse. It was also the first self-management trial for CKD in Vietnam and it contributes to extending nursing knowledge in this area internationally so that patient care can be improved .

　　结论

　　自我管理计划被认为是一种有效而简单的方法，可以让患有CKD的人们提高相关知识水平，信心和技能来管理他们的疾病。这种方法还表明，护士可以在繁忙的门诊诊所提供自我管理教育。这项研究具有重要的意义，它为临床实践中的自我管理的发展和应用、慢性病护理和护理工作提供了资料。这也是在越南的首个CKD自我管理试验，有助于在国际上推广该领域的护理知识，从而改善对患者的护理水平。