Isautier Jennifer, Webster Angela C, Lambert Kelly, Shepherd Heather L, McCaffery Kirsten, Sud Kamal, Kim Jinman, Liu Na, De La Mata Nicole, Raihana Shahreen, Kelly Patrick J, Muscat Danielle M
Sydney Health Literacy Lab, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
JMIR Res Protoc. 2022 Aug 31;11(8):e39909. doi: 10.2196/39909.
We developed a smartphone app-the SUCCESS (Supporting Culturally and Linguistically Diverse CKD Patients to Engage in Shared Decision-Making Successfully) app-to support Australian adults with kidney failure undertaking dialysis to actively participate in self-management and decision-making. The content of the SUCCESS app was informed by a theoretical model of health literacy that recognizes the importance of reducing the complexity of health information as well as providing skills necessary to access, understand, and act on this information.
The purpose of this study is to investigate the efficacy of the SUCCESS app intervention.
We designed a multicenter pragmatic randomized controlled trial to compare the SUCCESS app plus usual care (intervention) to usual care alone (control). A total of 384 participants receiving in-center or home-based hemodialysis or peritoneal dialysis will be recruited from six local health districts in the Greater Sydney region, New South Wales, Australia. To avoid intervention contamination, a pragmatic randomization approach will be used for participants undergoing in-center dialysis, in which randomization will be based on the days they receive hemodialysis and by center (ie, Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). Participants undergoing home-based dialysis will be individually randomized centrally using simple randomization and two stratification factors: language spoken at home and research site. Consenting participants will be invited to use the SUCCESS app for 12 months. The primary endpoints, which will be assessed after 3, 6, and 12 months of app usage, are health literacy skills, evaluated using the Health Literacy Questionnaire; decision self-efficacy, evaluated using the Decision Self-Efficacy Scale; and rates of unscheduled health encounters. Secondary outcomes include patient-reported outcomes (ie, quality of life, evaluated with the 5-level EQ-5D; knowledge; confidence; health behavior; and self-management) and clinical outcomes (ie, symptom burden, evaluated with the Palliative care Outcome Scale-Renal; nutritional status, evaluated with the Patient-Generated Subjective Global Assessment; and intradialytic weight gain). App engagement will be determined via app analytics. All analyses will be undertaken using an intention-to-treat approach comparing the intervention and usual care arms.
The study has been approved by Nepean Blue Mountains Human Research Ethics Committee (2020/ETH00910) and recruitment has begun at nine sites. We expect to finalize data collection by 2023 and publish the manuscript by 2024.
Enhancing health literacy skills for patients undergoing hemodialysis is an important endeavor, given the association between poor health literacy and poor health outcomes, especially among culturally diverse groups. The findings from this trial will be published in peer-reviewed journals and disseminated at conferences, and updates will be shared with partners, including participating local health districts, Kidney Health Australia, and consumers. The SUCCESS app will continue to be available to all participants following trial completion.
Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000235808; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380754&isReview=true.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39909.
我们开发了一款智能手机应用程序——SUCCESS（支持文化和语言多样化的慢性肾脏病患者成功参与共同决策）应用程序，以支持患有肾衰竭并正在接受透析治疗的澳大利亚成年人积极参与自我管理和决策。SUCCESS应用程序的内容是根据一种健康素养理论模型设计的，该模型认识到降低健康信息复杂性以及提供获取、理解和基于此信息采取行动所需技能的重要性。
本研究旨在调查SUCCESS应用程序干预措施的效果。
我们设计了一项多中心实用随机对照试验，将SUCCESS应用程序加常规护理（干预组）与单纯常规护理（对照组）进行比较。将从澳大利亚新南威尔士州大悉尼地区的六个当地卫生区招募总共384名接受中心血液透析、家庭血液透析或腹膜透析的参与者。为避免干预污染，对于接受中心透析的参与者将采用实用随机化方法，其中随机化将基于他们接受血液透析的日期和中心（即周一、周三和周五或周二、周四和周六）。接受家庭透析的参与者将使用简单随机化和两个分层因素（在家中使用的语言和研究地点）进行集中个体随机化。同意参与的参与者将被邀请使用SUCCESS应用程序12个月。主要终点将在应用程序使用3个月、6个月和12个月后进行评估，包括使用健康素养问卷评估的健康素养技能、使用决策自我效能量表评估的决策自我效能以及非计划健康就诊率。次要结局包括患者报告的结局（即使用5级EQ-5D评估的生活质量、知识、信心、健康行为和自我管理）和临床结局（即使用姑息治疗结局量表-肾脏评估的症状负担、使用患者生成的主观整体评估评估的营养状况以及透析期间体重增加）。应用程序参与度将通过应用程序分析来确定。所有分析将采用意向性分析方法，比较干预组和常规护理组。
该研究已获得内佩恩蓝山人类研究伦理委员会（2020/ETH00910）的批准，并且已经在九个地点开始招募。我们预计到2023年完成数据收集，并在2024年发表手稿。
鉴于健康素养差与不良健康结局之间的关联，尤其是在文化多样化群体中，提高接受血液透析患者的健康素养技能是一项重要工作。该试验的结果将发表在同行评审期刊上并在会议上传播，更新内容将与合作伙伴分享，包括参与的当地卫生区、澳大利亚肾脏健康组织和消费者。试验完成后，SUCCESS应用程序将继续向所有参与者提供。
澳大利亚新西兰临床试验注册中心（ANZCTR）ACTRN12621000235808；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380754&isReview=true。
国际注册报告识别号（IRRID）：DERR1-10.2196/39909。
