QOL and Mental Health Using APD With Remote Monitoring System

NCT07012499 | Enrolling By Invitation DMC

• 1 other identifier: 2020-08-0031
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

remote control; Automated peritoneal dialysis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• change volume status

  6, 12 months

• change nutrition status

  6, 12 months

• dialysis adequacy

  6,12 months

• Questionnaire form.

  6,12 months

• adverse events

  12 months

Other Outcomes (2)

• Total time or PD

  90 Days

• Medical coast of treatment

  12 month

Study Arms (2)

APD with Sharesource

EXPERIMENTAL

Patients received APD with Sharesource system

Device: Automated peritoneal dialysis with Sharesource device

APD without Sharesource

PLACEBO COMPARATOR

Patients received APD without sharesource

Device: APD without sharesource

Interventions

Automated peritoneal dialysis with Sharesource device DEVICE

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

APD with Sharesource

APD without sharesource DEVICE

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

APD without Sharesource

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Kangwondo, 26426, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of the APD model with internet-based feedback system versus without it

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: June 10, 2025
• Study Start: December 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)