Меню
Набор по приглашению NCT07012499

QOL and Mental Health Using APD With Remote Monitoring System

Без фазы С лечением Quality of Life Mental Health Wellness 1

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Automated peritoneal dialysis with Sharesource device, APD without sharesource.
Кому может быть актуально
Состояния в реестре: Quality of Life, Mental Health Wellness 1. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.).

Вмешательства

  • Устройство Automated peritoneal dialysis with Sharesource device
    Patients receive APD with an FMC device that contains sharesource software which can communicate with the medical team.
  • Устройство APD without sharesource
    Patients received APD with Same machine but this patients dose not using sharesource software

Первичные конечные точки

  • changes of quality of life KDQOL-36 [Срок оценки: 6, 12 months]
  • changes of quality of life PHQ-9 [Срок оценки: 6, 12 months]
  • changes of quality of life BDI [Срок оценки: 6, 12 months]
  • changes of quality of life CESD [Срок оценки: 6, 12 months]
Вторичные конечные точки (6)
  • change volume status [Срок оценки: 6, 12 months]
  • change nutrition status [Срок оценки: 6, 12 months]
  • dialysis adequacy [Срок оценки: 6,12 months]
  • Questionnaire form. [Срок оценки: 6,12 months]
  • adverse events [Срок оценки: 12 months]
  • Body mass index (BMI: kg/m2) [Срок оценки: 6 months, 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Wonju Severance Christian Hospital — Wŏnju

Идентификаторы

NCT: NCT07012499 · 2020-08-0031

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗