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

18. August 2026 aktualisiert von: Vantive Health LLC

Clinical Effectiveness and Healthcare Resource Utilization in Patients With End-Stage Renal Disease Receiving Remote Patient Monitoring-Automated Peritoneal Dialysis, Manual Peritoneal Dialysis, or Hemodialysis: A Multicenter, Prospective, Observational Real-World Study

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

750

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
      • Beijing, Beijing Municipality, China, 100034
        • Noch keine Rekrutierung
        • Peking University First Hospital
        • Kontakt:
      • Beijing, Beijing Municipality, China, 100080
        • Noch keine Rekrutierung
        • Beijing Haidian Hospital
        • Kontakt:
      • Beijing, Beijing Municipality, China, 100191
        • Noch keine Rekrutierung
        • Peking University Third Hospital
        • Kontakt:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Noch keine Rekrutierung
        • The Second Affiliated Hospital of Chongqing Medical University
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Noch keine Rekrutierung
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Kontakt:
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Noch keine Rekrutierung
        • Hebei Medical University Third Hospital
        • Kontakt:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Noch keine Rekrutierung
        • The Second Affiliated Hospital of Harbin Medical University
        • Kontakt:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Noch keine Rekrutierung
        • Henan Provincial People's Hospital
        • Kontakt:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Noch keine Rekrutierung
        • Zhongnan Hospital of Wuhan University
        • Kontakt:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Noch keine Rekrutierung
        • The Third XIANGYA Hospital of Central South University
        • Kontakt:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Noch keine Rekrutierung
        • The First Affiliated Hospital of Baotou Medical College
        • Kontakt:
    • Jiangsu
      • Wuxi, Jiangsu, China, 214023
    • Jilin
      • Changchun, Jilin, China, 130041
        • Noch keine Rekrutierung
        • The Second Norman Bethune Hospital of Jilin University
        • Kontakt:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Noch keine Rekrutierung
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Kontakt:
    • Shandong
      • Qingdao, Shandong, China, 266555
        • Noch keine Rekrutierung
        • The Affiliated Hospital of Qingdao University
        • Kontakt:
      • Yantai, Shandong, China, 264000
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300190
        • Noch keine Rekrutierung
        • Tianjin First Central Hospital
        • Kontakt:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310007
        • Noch keine Rekrutierung
        • Hangzhou Hospital of Traditional Chinese Medicine
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

This study plans to screen Chinese patients receiving remote patient monitoring-automated peritoneal dialysis (RPM-APD), manual peritoneal dialysis (manual PD), or maintenance hemodialysis (HD). Each patient must meet all inclusion criteria and none of the exclusion criteria for this study. No exceptions are permitted under any circumstances.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
RPM-APD cohort
Gerät: Remote 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.
Manual PD cohort
Gerät: Manual 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.
HD cohort
Gerät: Maintenance 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Patient survival rates
Zeitfenster: 6, 12, and 24 months
6, 12, and 24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of Life Scores (EQ-5D-5L)
Zeitfenster: 6, 12 and 24 months
Change in quality of life scores measured using the EuroQol Five Dimensions (EQ-5D-5L) scales
6, 12 and 24 months
Quality of Life Scores (KDQOL-36)
Zeitfenster: 6, 12, and 24 months
Change in quality of life scores measured using the Kidney Disease Quality of Life-36 (KDQOL-36)
6, 12, and 24 months
Social Reintegration
Zeitfenster: 6, 12, and 24 months
Social functioning and reintegration assessed using the Work and Social Adjustment Scale (WSAS)
6, 12, and 24 months
Social Reintegration
Zeitfenster: 6, 12 and 24 months
Social functioning and reintegration assessed using the EQ-5D-5L
6, 12 and 24 months
Social Reintegration
Zeitfenster: 6, 12 and 24 months
Social functioning and reintegration assessed using supplementary questionnaires
6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Zeitfenster: 6, 12, and 24 months
Assessment of healthcare resource utilization including hospitalization rate
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Zeitfenster: 6, 12, and 24 months
Assessment of healthcare resource utilization including number of hospitalizations
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Zeitfenster: 6, 12, and 24 months
Assessment of healthcare resource utilization including length of hospital stay
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Zeitfenster: 6, 12, and 24 months
Assessment of healthcare resource utilization including outpatient and emergency visits
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Zeitfenster: 6, 12, and 24 months
Assessment of healthcare resource utilization including total hospitalization costs
6, 12, and 24 months
Healthcare workforce utilization
Zeitfenster: 6, 12, and 24 months
Time and resource utilization by healthcare providers per patient including remote communication collected via healthcare staff questionnaire
6, 12, and 24 months
Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs)
Zeitfenster: 6, 12, and 24 months
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
6, 12, and 24 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of infection-related complications
Zeitfenster: 1, 3, 6, 12, 18, and 24 months
Infection related complications including but not limited to peritonitis, pulmonary infections, peritoneal dialysis catheter-related infections, hemodialysis catheter-related infections, and urinary tract infections.
1, 3, 6, 12, 18, and 24 months
Incidence of cardiovascular and cerebrovascular events
Zeitfenster: 1, 3, 6, 12, 18, and 24 months
Cardiovascular events include but are not limited to acute myocardial infarction, angina, sudden cardiac death, heart failure, arrhythmia and other ischemic heart diseases. Cerebrovascular events include but are not limited to stroke, cerebral hemorrhage, and peripheral arterial disease.
1, 3, 6, 12, 18, and 24 months
Incidence of dialysis access-related complications
Zeitfenster: 1, 3, 6, 12, 18, and 24 months
dialysis access-related complications including access-related infections and dysfunction for both PD and HD: Peritoneal dialysis catheter-related infections, Peritoneal dialysis catheter dysfunction, Hemodialysis access-related infections and Hemodialysis access dysfunction
1, 3, 6, 12, 18, and 24 months
Change from baseline in 24-hour urine output
Zeitfenster: 3, 12, and 24 months
For PD patients, 24-hour urine volume data is collected during dialysis adequacy assessment. For HD patients, 24-hour urine volume is the average volume over two consecutive days (a dialysis day and a non-dialysis day).
3, 12, and 24 months
Dialysis quality control indicators
Zeitfenster: 6, 12, and 24 months
The rate of achieving the standard for small molecule solute clearance
6, 12, and 24 months
Dialysis quality control indicators
Zeitfenster: 6, 12, and 24 months
Hypertension control rate: The proportion of maintenance HD or PD patients meeting the blood pressure control targets during the assessment period
6, 12, and 24 months
Dialysis quality control indicators
Zeitfenster: 6, 12, and 24 months
Renal anemia control rate: The proportion of maintenance HD or PD patients with hemoglobin (Hb) levels ≥ 110 g/L during the assessment period
6, 12, and 24 months
Dialysis quality control indicators
Zeitfenster: 6, 12, and 24 months
CKD-Mineral and Bone Disorder (CKD-MBD) indicators control rate: The proportion of maintenance HD or PD patients meeting the control standards for CKD-MBD indicators during the assessment period
6, 12, and 24 months
Dialysis quality control indicators
Zeitfenster: 6, 12, and 24 months
Serum albumin control rate: The proportion of maintenance HD or PD patients with serum albumin levels ≥ 35 g/L during the assessment period
6, 12, and 24 months
Proportion of patients transferred to HD
Zeitfenster: 6, 12, and 24 months
Transferred to HD is defined as transfer from PD to HD for ≥ 30 consecutive days
6, 12, and 24 months
Ultrafiltration volume and solute clearance
Zeitfenster: 3, 12, and 24 months
Collection of data from dialysis adequacy assessment including 24-hour ultrafiltration volume
3, 12, and 24 months
Ultrafiltration volume and solute clearance
Zeitfenster: 3, 12, and 24 months
Collection of data from dialysis adequacy assessment including weekly residual renal Kt/V, weekly dialysis Kt/V, and weekly total Kt/V
3, 12, and 24 months
Ultrafiltration volume and solute clearance
Zeitfenster: 3, 12, and 24 months
Collection of data from dialysis adequacy assessment including weekly residual renal creatinine clearance (Ccr), weekly dialysis Ccr, and weekly total Ccr.
3, 12, and 24 months
Change from baseline in blood pressure
Zeitfenster: 1, 3, 6, 12, 18, and 24 months
Office blood pressure (OBP), defined as blood pressure (systolic and diastolic) measured in a healthcare setting by a physician, nurse, or other trained professional using a validated sphygmomanometer.
1, 3, 6, 12, 18, and 24 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Vantive Health LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juni 2029

Studienabschluss (Geschätzt)

30. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

20. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. August 2026

Zuerst gepostet (Tatsächlich)

24. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BXU625422

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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