Mental Health Wellness 1, Quality of Life
Conditions
Keywords
remote control, Automated peritoneal dialysis
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.).
Interventions
DEVICEAutomated peritoneal dialysis with Sharesource device
Patients receive APD with an FMC device that contains sharesource software which can communicate with the medical team.
DEVICEAPD without sharesource
Patients received APD with Same machine but this patients dose not using sharesource software
Sponsors
Wonju Severance Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Comparison of the APD model with internet-based feedback system versus without it
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes of quality of life BDI | 6, 12 months |
| changes of quality of life CESD | 6, 12 months |
| changes of quality of life KDQOL-36 | 6, 12 months |
| changes of quality of life PHQ-9 | 6, 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire form. | 6,12 months | change of PD perscription, personalized prescription changes, hospital admission, ER admission, unplanned hospital visit, exchanges over telephone |
| Body mass index (BMI: kg/m2) | 6 months, 12 months | — |
| adverse events | 12 months | peritonitis, mechanical comlications |
| change volume status | 6, 12 months | Overhydration (measured by bioimpedance device) |
| change nutrition status | 6, 12 months | GNRI (geriatric nutrition risk index), Handgrip strength test (kg) |
| dialysis adequacy | 6,12 months | KT/V |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total time or PD | 90 Days | Total time of PD |
| Medical coast of treatment | 12 month | Medical coast |
Countries
South Korea
Outcome results
None listed