QOL and Mental Health Using APD With Remote Monitoring System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated peritoneal dialysis with Sharesource device, APD without sharesource.
- Who it may be relevant to
- Registry conditions: Quality of Life, Mental Health Wellness 1. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.).
Interventions
- Device Automated peritoneal dialysis with Sharesource device
Patients receive APD with an FMC device that contains sharesource software which can communicate with the medical team. - Device APD without sharesource
Patients received APD with Same machine but this patients dose not using sharesource software
Primary outcome measures
- changes of quality of life KDQOL-36 [Time frame: 6, 12 months]
- changes of quality of life PHQ-9 [Time frame: 6, 12 months]
- changes of quality of life BDI [Time frame: 6, 12 months]
- changes of quality of life CESD [Time frame: 6, 12 months]
Secondary outcome measures (6)
- change volume status [Time frame: 6, 12 months]
- change nutrition status [Time frame: 6, 12 months]
- dialysis adequacy [Time frame: 6,12 months]
- Questionnaire form. [Time frame: 6,12 months]
- adverse events [Time frame: 12 months]
- Body mass index (BMI: kg/m2) [Time frame: 6 months, 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Wonju Severance Christian Hospital — Wŏnju
Identifiers
NCT: NCT07012499 · 2020-08-0031