跳至主要内容
临床试验/NCT07012499
NCT07012499Enrolling By Invitation不适用

The Investigation of Quality of Life and Mental Health Using Remote Monitoring System (Sharesource) With Automated Peritoneal Dialysis in End-stage Renal Disease Patients

Wonju Severance Christian Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
2
主要终点
changes of quality of life KDQOL-36

研究概览

简要总结

Although peritoneal dialysis (PD) is a representative renal replacement therapy along with hemodialysis, number of PD patients decreases every year. Among the various contributing factors for such trends, the essential issue that the patients should perform dialytic therapy by themselves is thought to be critical for the patients to avoid choosing PD as primary dialytic therapy. In particular, unlike hemodialysis, the patients with PD have troubles in getting timely medical advice in their daily life, although continuous advice are essential for maintaining therapy. Thus, remote monitoring and control system is believed to be useful in PD therapy.

Automated PD (APD) is a good option because of its convenience and improved accessibility. So, in Korea, although the rate of incident PD patients was decreased, the proportion of APD were rapidly increased (3.7% in 2001 vs. 39% in 2018, Korean Society of Nephrology (KSN) data) In the COVID-19 pandemic, the investigators should improve Remote therapy monitoring (RTM). Technologies that collect medical information and transmit it to health care providers for patient management, have the potential to improve the patients' outcomes without visiting hospital receiving automated peritoneal dialysis (APD) at home. However, there are only a few retrospective studies and no prospective study about remote patients monitoring programs in APD. Remote medical service is currently illegal in South Korea. However, recently the Korean government has approved remote medical service in only a few areas of Gangwon province, including Wonju city, which belongs to our institution.

Thus, the investigators aim to use such a benefit to investigate the 'Quality of Life (QOL)' in Korean patients undergoing APD. The investigators plan to compare the various clinical indexes, including mainly QOL, mental health focusing depression, and volume-nutritional status between the patients with previous classic APD and APD combined by the SharesourceTM system (Baxter Co.).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • More than 18 years old
  • ESRD patients on APD(≥1 month)
  • Consent to participate in the study

排除标准

  • Patients who plan to receive kidney transplantation within 1 year
  • Patients with co-morbidities: cardiovascular disease(myocardial infarction, heart failure, arrhythmia), cancer, psychiatric diseases, liver cirrhosis

结局指标

主要结局

changes of quality of life KDQOL-36

时间窗: 6, 12 months

changes of quality of life PHQ-9

时间窗: 6, 12 months

changes of quality of life BDI

时间窗: 6, 12 months

changes of quality of life CESD

时间窗: 6, 12 months

次要结局

  • adverse events(12 months)
  • change volume status(6, 12 months)
  • change nutrition status(6, 12 months)
  • dialysis adequacy(6,12 months)
  • Questionnaire form.(6,12 months)
  • Body mass index (BMI: kg/m2)(6 months, 12 months)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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