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.
Study Type
OBSERVATIONAL
Enrollment
750
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.
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.
Maintenance HD refers to conventional hemodialysis therapy performed by professional staff in a dialysis center/hemopurification unit, initiated after the induction dialysis period.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Haidian Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGGuangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHebei Medical University Third Hospital
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
NOT_YET_RECRUITING...and 10 more locations
Patient survival rates
Time frame: 6, 12, and 24 months
Quality of Life Scores (EQ-5D-5L)
Change in quality of life scores measured using the EuroQol Five Dimensions (EQ-5D-5L) scales
Time frame: 6, 12 and 24 months
Quality of Life Scores (KDQOL-36)
Change in quality of life scores measured using the Kidney Disease Quality of Life-36 (KDQOL-36)
Time frame: 6, 12, and 24 months
Social Reintegration
Social functioning and reintegration assessed using the Work and Social Adjustment Scale (WSAS)
Time frame: 6, 12, and 24 months
Social Reintegration
Social functioning and reintegration assessed using the EQ-5D-5L
Time frame: 6, 12 and 24 months
Social Reintegration
Social functioning and reintegration assessed using supplementary questionnaires
Time frame: 6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including hospitalization rate
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including number of hospitalizations
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including length of hospital stay
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including outpatient and emergency visits
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Assessment of healthcare resource utilization including total hospitalization costs
Time frame: 6, 12, and 24 months
Healthcare workforce utilization
Time and resource utilization by healthcare providers per patient including remote communication collected via healthcare staff questionnaire
Time frame: 6, 12, and 24 months
Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs)
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
Time frame: 6, 12, and 24 months
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