QOL and Mental Health Using APD With Remote Monitoring System

NCT ID: NCT07012499

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2025-12-31

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.).

Conditions

Quality of Life; Mental Health Wellness 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

APD with Sharesource

Patients received APD with Sharesource system

Group Type: EXPERIMENTAL

Automated peritoneal dialysis with Sharesource device

Intervention Type: DEVICE

Patients receive APD with an FMC device that contains sharesource software which can communicate with the medical team.

APD without Sharesource

Patients received APD without sharesource

Group Type: PLACEBO_COMPARATOR

APD without sharesource

Intervention Type: DEVICE

Patients received APD with Same machine but this patients dose not using sharesource software

Interventions

Automated peritoneal dialysis with Sharesource device

Patients receive APD with an FMC device that contains sharesource software which can communicate with the medical team.

Intervention Type: DEVICE

APD without sharesource

Patients received APD with Same machine but this patients dose not using sharesource software

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wonju Severance Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wonju Severance Christian Hospital

Wŏnju, Kangwondo, South Korea

Countries

South Korea

Other Identifiers

2020-08-0031

Identifier Type: -

Identifier Source: org_study_id