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Quality of LifeNCT07012499

QOL and Mental Health Using APD With Remote Monitoring System

A study testing Automated peritoneal dialysis with Sharesource device and APD without sharesource in people with Quality of Life and Mental Health Wellness 1, run by Wonju Severance Christian Hospital at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life, Mental Health Wellness 1
What is being tested?
Automated peritoneal dialysis with Sharesource device and APD without sharesource
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Wonju Severance Christian Hospital

    Wŏnju, Kangwondo, 26426

Other trials in South Korea

About this study

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

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.).

Being tested
Automated peritoneal dialysis with Sharesource device, APD without sharesource
Keywords
remote control, Automated peritoneal dialysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated peritoneal dialysis with Sharesource deviceDevice

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

  • APD without sharesourceDevice

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

Study groups in NCT07012499
Study groupRoleWhat they receive
APD with SharesourceExperimentalPatients received APD with Sharesource system
Receives: Device: Automated peritoneal dialysis with Sharesource device
APD without SharesourcePlacebo comparatorPatients received APD without sharesource
Receives: Device: APD without sharesource

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes of quality of life KDQOL-36

    Measured: 6, 12 months

  2. changes of quality of life PHQ-9

    Measured: 6, 12 months

  3. changes of quality of life BDI

    Measured: 6, 12 months

  4. changes of quality of life CESD

    Measured: 6, 12 months

Secondary outcomes (6)

  1. change volume status

    Overhydration (measured by bioimpedance device)

    Measured: 6, 12 months

  2. change nutrition status

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

    Measured: 6, 12 months

  3. dialysis adequacy

    KT/V

    Measured: 6,12 months

  4. Questionnaire form.

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

    Measured: 6,12 months

  5. adverse events

    peritonitis, mechanical comlications

    Measured: 12 months

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

    Measured: 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparison of the APD model with internet-based feedback system versus without it
Masking
Single blind
Who is masked
Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07012499
Sponsor's protocol ID
2020-08-0031
Status last verified
Jun 2025
First submitted
24 Feb 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Automated peritoneal dialysis with Sharesource device and APD without sharesource in people with Quality of Life and Mental Health Wellness 1, run by Wonju Severance Christian Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes of quality of life KDQOL-36 (time frame: 6, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07012499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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