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Enrolling by Invitation

NCT Number: NCT07012499

QOL and Mental Health Using APD With Remote Monitoring System

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.).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonju Severance Christian Hospital

Wŏnju, Kangwondo, 26426, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 without sharesource

Device

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

Primary outcomes

  1. changes of quality of life KDQOL-36

    Time frame: 6, 12 months

  2. changes of quality of life PHQ-9

    Time frame: 6, 12 months

  3. changes of quality of life BDI

    Time frame: 6, 12 months

  4. changes of quality of life CESD

    Time frame: 6, 12 months

Secondary outcomes

  1. change volume status

    Time frame: 6, 12 months

    Overhydration (measured by bioimpedance device)

  2. change nutrition status

    Time frame: 6, 12 months

    GNRI (geriatric nutrition risk index), Handgrip strength test (kg)

  3. dialysis adequacy

    Time frame: 6,12 months

    KT/V

  4. Questionnaire form.

    Time frame: 6,12 months

    change of PD perscription, personalized prescription changes, hospital admission, ER admission, unplanned hospital visit, exchanges over telephone

  5. adverse events

    Time frame: 12 months

    peritonitis, mechanical comlications

  6. Body mass index (BMI: kg/m2)

    Time frame: 6 months, 12 months

Other outcomes

  1. Total time or PD

    Time frame: 90 Days

    Total time of PD

  2. Medical coast of treatment

    Time frame: 12 month

    Medical coast

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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