QOL and Mental Health Using APD With Remote Monitoring System
- Conditions
- Quality of LifeMental Health Wellness 1
- Registration Number
- NCT07012499
- Lead Sponsor
- Wonju Severance Christian Hospital
- Brief Summary
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.).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- More than 18 years old
- ESRD patients on APD(≥1 month)
- Consent to participate in the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method changes of quality of life KDQOL-36 6, 12 months changes of quality of life PHQ-9 6, 12 months changes of quality of life BDI 6, 12 months changes of quality of life CESD 6, 12 months
- Secondary Outcome Measures
Name Time Method Questionnaire form. 6,12 months change of PD perscription, personalized prescription changes, hospital admission, ER admission, unplanned hospital visit, exchanges over telephone
adverse events 12 months peritonitis, mechanical comlications
Body mass index (BMI: kg/m2) 6 months, 12 months change volume status 6, 12 months Overhydration (measured by bioimpedance device)
change nutrition status 6, 12 months GNRI (geriatric nutrition risk index), Handgrip strength test (kg)
dialysis adequacy 6,12 months KT/V
Trial Locations
- Locations (1)
Wonju Severance Christian Hospital
🇰🇷Wŏnju, Kangwondo, Korea, Republic of