Clinical trial NCT07012499: QOL and Mental Health Using APD With Remote Monitoring System
Official title: The Investigation of Quality of Life and Mental Health Using Remote Monitoring System (Sharesource) With Automated Peritoneal Dialysis in End-stage Renal Disease Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Quality of Life
Mental Health Wellness 1
Keywords: remote control
Automated peritoneal dialysis
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of the APD model with internet-based feedback system versus without it
Primary purpose: TREATMENT

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.).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: changes of quality of life KDQOL-36
timeFrame: 6, 12 months
measure: changes of quality of life PHQ-9
timeFrame: 6, 12 months
measure: changes of quality of life BDI
timeFrame: 6, 12 months
measure: changes of quality of life CESD
timeFrame: 6, 12 months
Secondary outcomes:
measure: change volume status
timeFrame: 6, 12 months
measure: change nutrition status
timeFrame: 6, 12 months
measure: dialysis adequacy
timeFrame: 6,12 months
measure: Questionnaire form.
timeFrame: 6,12 months
measure: adverse events
timeFrame: 12 months
measure: Body mass index (BMI: kg/m2)
timeFrame: 6 months, 12 months
Other outcomes:
measure: Total time or PD
timeFrame: 90 Days
measure: Medical coast of treatment
timeFrame: 12 month
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Kangwondo
Study officials:
References: