Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD)
Conditions
Keywords
RPM-APD, Manual PD, Maintenance HD
Brief summary
This is a multicenter, prospective, observational real-world study designed to evaluate clinical effectiveness, quality of life, and healthcare resource utilization in patients with end-stage renal disease (ESRD) initiating dialysis therapy in China. Participants will be grouped according to the dialysis modality selected through routine clinical practice and shared decision-making with their treating physicians: remote patient monitoring-assisted automated peritoneal dialysis (RPM-APD), manual peritoneal dialysis (PD), or maintenance hemodialysis (HD). No study-specific interventions will be assigned. The study will compare outcomes across these cohorts, including quality of life, social reintegration, clinical outcomes (e.g., complications and survival), and healthcare resource utilization. Propensity score matching will be applied to adjust for baseline differences between cohorts.
Interventions
DEVICERemote patient monitoring-automated peritoneal (RPM-APD)
RPM-APD refers to peritoneal dialysis performed at home using an APD cycler, with the prescription, treatment process, monitoring, and management conducted via a remote management system.
DEVICEManual peritoneal dialysis (PD) cohort
Manual PD refers to home-based dialysis exchange therapy performed by the patient/caregiver according to the physician's prescription without the use of automated equipment.
DEVICEMaintenance hemodialysis (HD)
Maintenance HD refers to conventional hemodialysis therapy performed by professional staff in a dialysis center/hemopurification unit, initiated after the induction dialysis period.
Sponsors
Vantive Health LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years and \< 80 years. * Diagnosed with ESRD and planned to initiate RPM-APD / manual PD / HD as maintenance dialysis within 3 months after signing the ICF. * Able to continue long-term follow-up and treatment at the study site after enrollment. * Voluntarily sign the ICF and are able to complete study visits and questionnaires as required by the Investigator or have a caregiver to assist in completing study-related procedures.
Exclusion criteria
* Diagnosed with acute kidney injury (AKI). * Received dialysis therapy for more than 1 month. * History of kidney transplantation. * Presence of other severe diseases, such as malignancies with active or residual lesions despite treatment, systemic infections, decompensated liver cirrhosis, severe lactic acidosis, etc. * Patients with HIV infection or syphilis infection. * Presence of psychiatric disorders or inability to cooperate. * Pregnant or breastfeeding women, as well as women of childbearing potential unwilling to use effective contraception during the study period. * Currently participating in another interventional study or having participated in another interventional study within 1 month prior to enrollment. * Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient survival rates | 6, 12, and 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Scores (EQ-5D-5L) | 6, 12 and 24 months | Change in quality of life scores measured using the EuroQol Five Dimensions (EQ-5D-5L) scales |
| Quality of Life Scores (KDQOL-36) | 6, 12, and 24 months | Change in quality of life scores measured using the Kidney Disease Quality of Life-36 (KDQOL-36) |
| Social Reintegration | 6, 12, and 24 months | Social functioning and reintegration assessed using the Work and Social Adjustment Scale (WSAS) |
| Healthcare Resource Utilization (Direct Medical Costs) | 6, 12, and 24 months | Assessment of healthcare resource utilization including hospitalization rate |
| Healthcare workforce utilization | 6, 12, and 24 months | Time and resource utilization by healthcare providers per patient including remote communication collected via healthcare staff questionnaire |
| Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs) | 6, 12, and 24 months | Costs related to non-medical expenditures and productivity loss collected via patient questionnaires |
Countries
China
Contacts
CONTACTGlobal CORP Clinical Trials Disclosure
Outcome results
None listed