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

18 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

750

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
RPM-APD cohort
Dispositivo: 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
Dispositivo: 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
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Patient survival rates
Lasso di tempo: 6, 12, and 24 months
6, 12, and 24 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life Scores (EQ-5D-5L)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6, 12 and 24 months
Social functioning and reintegration assessed using the EQ-5D-5L
6, 12 and 24 months
Social Reintegration
Lasso di tempo: 6, 12 and 24 months
Social functioning and reintegration assessed using supplementary questionnaires
6, 12 and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Lasso di tempo: 6, 12, and 24 months
Assessment of healthcare resource utilization including hospitalization rate
6, 12, and 24 months
Healthcare Resource Utilization (Direct Medical Costs)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 6, 12, and 24 months
Assessment of healthcare resource utilization including total hospitalization costs
6, 12, and 24 months
Healthcare workforce utilization
Lasso di tempo: 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)
Lasso di tempo: 6, 12, and 24 months
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
6, 12, and 24 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of infection-related complications
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vantive Health LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 giugno 2026

Completamento primario (Stimato)

30 giugno 2029

Completamento dello studio (Stimato)

30 giugno 2029

Date di iscrizione allo studio

Primo inviato

20 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 agosto 2026

Primo Inserito (Effettivo)

24 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BXU625422

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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