Design and rationale of the SMaRRT-HD study: A pragmatic, randomized trial of symptom monitoring for individuals receiving maintenance hemodialysis

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-08-30 DOI:10.1016/j.cct.2025.108058

Jennifer E. Flythe , Cassandra B. Picataggio , Leah Bernardo , Lorien S. Dalrymple , Robert J. Kossmann , Darren A. DeWalt , Laura C. Hanson , Virginia Wang , Mark L. Unruh , Jesse Y. Hsu , Laura M. Dember

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引用次数: 0

Abstract

Individuals with hemodialysis-dependent kidney failure often suffer from numerous symptoms that contribute to poor patient outcomes. The Symptom Monitoring in Renal Replacement Therapy-Hemodialysis (SMaRRT-HD) Study is a pragmatic randomized trial of monitoring and follow-up of symptoms for individuals receiving maintenance hemodialysis. The trial uses an effectiveness-implementation hybrid design with randomization at the clinic level to compare the effectiveness of once monthly symptom monitoring with supported clinician follow-up via an electronic patient-reported outcome measure (ePROM) system called SMaRRT-HD compared to routine symptom monitoring without supported follow-up (Usual Care) to improve patient-reported and biomedical outcomes over a 12-month intervention period. This manuscript describes the design of the trial with a focus on the effectiveness evaluation component. The primary outcome is symptom severity ascertained with the Dialysis Symptom Index at 6 and 12 months. Secondary outcomes are additional patient-reported outcomes (PROs) including health-related quality of life, fatigue, pain, hemodialysis recovery time, depression, anxiety, and healthcare engagement and biomedical outcomes including hospitalizations, missed hemodialysis treatments, and shortened hemodialysis treatments. Exploratory outcomes include death and quality of communication between patients and clinicians. The trial will include up to 36 hemodialysis clinics located across the United States. The enrollment targets are 2400 participants for the Full Cohort from which the biomedical outcomes will be ascertained, and 1200 participants for the PRO Subset from which PROs will be ascertained. The findings of the trial will inform approaches to symptom monitoring and follow-up for people with hemodialysis-dependent kidney failure.

Clinical Trials Registration Number: NCT05738330

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SMaRRT-HD研究的设计和基本原理：对接受维持性血液透析的个体进行症状监测的一项实用的随机试验。

血液透析依赖性肾衰竭患者通常会出现多种症状，导致患者预后不佳。肾替代疗法-血液透析症状监测（SMaRRT-HD）研究是一项实用的随机试验，对接受维护性血液透析的个体进行症状监测和随访。该试验采用临床水平随机化的有效性-实施混合设计，比较每月一次的症状监测与支持临床医生随访的有效性，通过电子患者报告结果测量（ePROM）系统称为SMaRRT-HD，与常规症状监测相比，没有支持随访（常规护理），在12个月的干预期内改善患者报告和生物医学结果。这份手稿描述了试验的设计，重点是有效性评估部分。主要结局是在6和12 个月时用透析症状指数确定症状严重程度。次要结局是患者报告的额外结局（PROs），包括与健康相关的生活质量、疲劳、疼痛、血液透析恢复时间、抑郁、焦虑和医疗保健参与，以及生物医学结局，包括住院、错过血液透析治疗和缩短血液透析治疗。探索性结果包括死亡和患者与临床医生之间的沟通质量。该试验将包括位于美国各地的多达36家血液透析诊所。纳入目标为全队列2400名参与者，从中确定生物医学结果，而PRO子集1200名参与者将从中确定PRO。该试验的发现将为血液透析依赖性肾衰竭患者的症状监测和随访方法提供信息。临床试验注册号：NCT05738330。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.