Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities
18 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Studietyp
Observationell
Inskrivning (Beräknad)
750
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Global CORP Clinical Trials Disclosure
- Telefonnummer: +1 2249484283
- E-post: Global.CORP.ClinicalTrialsDisclosure@vantive.com
Studieorter
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100029
- Rekrytering
- China-Japan Friendship Hospital
-
Kontakt:
- Wenge Li
- E-post: wenge_lee2002@126.com
-
Beijing, Beijing Municipality, Kina, 100034
- Har inte rekryterat ännu
- Peking University First Hospital
-
Kontakt:
- Jie Dong
- E-post: jie.dong@bjmu.edu.cn
-
Beijing, Beijing Municipality, Kina, 100080
- Har inte rekryterat ännu
- Beijing Haidian Hospital
-
Kontakt:
- Gang Fu
- E-post: fugang126@126.com
-
Beijing, Beijing Municipality, Kina, 100191
- Har inte rekryterat ännu
- Peking University Third Hospital
-
Kontakt:
- Wen Tang
- E-post: tangwen@126.com
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400010
- Har inte rekryterat ännu
- The Second Affiliated Hospital of Chongqing Medical University
-
Kontakt:
- Xiaohui Liao
- E-post: 1263201771@qq.com
-
-
Guangdong
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Guangzhou, Guangdong, Kina, 510120
- Har inte rekryterat ännu
- Guangdong Provincial Hospital of Traditional Chinese Medicine
-
Kontakt:
- Xusheng Liu
- E-post: liuxu801@126.com
-
-
Hebei
-
Shijiazhuang, Hebei, Kina, 050051
- Har inte rekryterat ännu
- Hebei Medical University Third Hospital
-
Kontakt:
- Yanqing Chi
- E-post: lilychi@sina.com
-
-
Heilongjiang
-
Harbin, Heilongjiang, Kina, 150001
- Har inte rekryterat ännu
- The Second Affiliated Hospital of Harbin Medical University
-
Kontakt:
- Xuanyi Du
- E-post: dxy_shennei@126.com
-
-
Henan
-
Zhengzhou, Henan, Kina, 450003
- Har inte rekryterat ännu
- Henan Provincial People's Hospital
-
Kontakt:
- Fengmin Shao
- E-post: fengminshao@126.com
-
-
Hubei
-
Wuhan, Hubei, Kina, 430071
- Har inte rekryterat ännu
- Zhongnan Hospital of Wuhan University
-
Kontakt:
- Huiming Wang
- E-post: 736238012@qq.com
-
-
Hunan
-
Changsha, Hunan, Kina, 410013
- Har inte rekryterat ännu
- The Third XIANGYA Hospital of Central South University
-
Kontakt:
- Hao Zhang
- E-post: Zhanghaoliaoqing@163.com
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, Kina, 014010
- Har inte rekryterat ännu
- The First Affiliated Hospital of Baotou Medical College
-
Kontakt:
- Lei Nan
- E-post: nanlei566@163.com
-
-
Jiangsu
-
Wuxi, Jiangsu, Kina, 214023
- Har inte rekryterat ännu
- Wuxi People's Hospital
-
Kontakt:
- Liang Wang
- E-post: wangliang_wuxi@126.com
-
-
Jilin
-
Changchun, Jilin, Kina, 130041
- Har inte rekryterat ännu
- The Second Norman Bethune Hospital of Jilin University
-
Kontakt:
- Wenpeng Cui
- E-post: wenpengcui@163.com
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710061
- Har inte rekryterat ännu
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Kontakt:
- Jing Lv
- E-post: drlvjing@163.com
-
-
Shandong
-
Qingdao, Shandong, Kina, 266555
- Har inte rekryterat ännu
- The Affiliated Hospital of Qingdao University
-
Kontakt:
- Guangqun Xing
- E-post: gqx99monash@163.com
-
Yantai, Shandong, Kina, 264000
- Har inte rekryterat ännu
- Yantai YuHuangDing Hospital
-
Kontakt:
- Peng Li
- E-post: yhdgcplipeng@163.com
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200233
- Har inte rekryterat ännu
- Shanghai Sixth People's Hospital
-
Kontakt:
- Niansong Wang
- E-post: wangniansong2012@163.com
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300190
- Har inte rekryterat ännu
- Tianjin First Central Hospital
-
Kontakt:
- Wenxiu Chang
- E-post: changwx@sina.com
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310007
- Har inte rekryterat ännu
- Hangzhou Hospital of Traditional Chinese Medicine
-
Kontakt:
- Mengli Tong
- E-post: 1994185637@qq.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
RPM-APD cohort
|
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
|
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
|
Maintenance HD refers to conventional hemodialysis therapy performed by professional staff in a dialysis center/hemopurification unit, initiated after the induction dialysis period.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Patient survival rates
Tidsram: 6, 12, and 24 months
|
6, 12, and 24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of Life Scores (EQ-5D-5L)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 6, 12 and 24 months
|
Social functioning and reintegration assessed using the EQ-5D-5L
|
6, 12 and 24 months
|
|
Social Reintegration
Tidsram: 6, 12 and 24 months
|
Social functioning and reintegration assessed using supplementary questionnaires
|
6, 12 and 24 months
|
|
Healthcare Resource Utilization (Direct Medical Costs)
Tidsram: 6, 12, and 24 months
|
Assessment of healthcare resource utilization including hospitalization rate
|
6, 12, and 24 months
|
|
Healthcare Resource Utilization (Direct Medical Costs)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 6, 12, and 24 months
|
Assessment of healthcare resource utilization including total hospitalization costs
|
6, 12, and 24 months
|
|
Healthcare workforce utilization
Tidsram: 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)
Tidsram: 6, 12, and 24 months
|
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
|
6, 12, and 24 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of infection-related complications
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
17 juni 2026
Primärt slutförande (Beräknad)
30 juni 2029
Avslutad studie (Beräknad)
30 juni 2029
Studieregistreringsdatum
Först inskickad
20 juli 2026
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2026
Första postat (Faktisk)
24 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Njursvikt, kronisk
- Njurinsufficiens, kronisk
- Sjukvårdskvalitet, tillgång och utvärdering
- Undersökningstekniker
- Epidemiologiska metoder
- Hälsovårdsutvärderingsmekanismer
- Hälsovårdskvalitet
- Folkhälsa
- Miljö och folkhälsa
- Epidemiologiska studier
- Epidemiologiska studieegenskaper
- Kohortstudier
Andra studie-ID-nummer
- BXU625422
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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