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

18 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

750

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
RPM-APD cohort
Dispositif: 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
Dispositif: 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
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Patient survival rates
Délai: 6, 12, and 24 months
6, 12, and 24 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Quality of Life Scores (EQ-5D-5L)
Délai: 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)
Délai: 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
Délai: 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
Délai: 6, 12 and 24 months
Social functioning and reintegration assessed using the EQ-5D-5L
6, 12 and 24 months
Social Reintegration
Délai: 6, 12 and 24 months
Social functioning and reintegration assessed using supplementary questionnaires
6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Délai: 6, 12, and 24 months
Assessment of healthcare resource utilization including hospitalization rate
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 6, 12, and 24 months
Assessment of healthcare resource utilization including total hospitalization costs
6, 12, and 24 months
Healthcare workforce utilization
Délai: 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)
Délai: 6, 12, and 24 months
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
6, 12, and 24 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Incidence of infection-related complications
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vantive Health LLC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 juin 2026

Achèvement primaire (Estimé)

30 juin 2029

Achèvement de l'étude (Estimé)

30 juin 2029

Dates d'inscription aux études

Première soumission

20 juillet 2026

Première soumission répondant aux critères de contrôle qualité

18 août 2026

Première publication (Réel)

24 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BXU625422

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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