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Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities

Recruitingn/aAges 18 Years - 79 YearsAllVantive Health LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged โ‰ฅ 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.
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What it tests

  • Remote patient monitoring-automated peritoneal (RPM-APD)
  • Manual peritoneal dialysis (PD) cohort
  • Maintenance hemodialysis (HD)
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Where

20 sites
China-Japan Friendship Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Beijing Haidian Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, China
Hebei Medical University Third Hospital
Shijiazhuang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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