Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities
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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Global CORP Clinical Trials Disclosure
- Numer telefonu: +1 2249484283
- E-mail: Global.CORP.ClinicalTrialsDisclosure@vantive.com
Lokalizacje studiów
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Chiny, 100029
- Rekrutacyjny
- China-Japan Friendship Hospital
-
Kontakt:
- Wenge Li
- E-mail: wenge_lee2002@126.com
-
Beijing, Beijing Municipality, Chiny, 100034
- Jeszcze nie rekrutacja
- Peking University First Hospital
-
Kontakt:
- Jie Dong
- E-mail: jie.dong@bjmu.edu.cn
-
Beijing, Beijing Municipality, Chiny, 100080
- Jeszcze nie rekrutacja
- Beijing Haidian Hospital
-
Kontakt:
- Gang Fu
- E-mail: fugang126@126.com
-
Beijing, Beijing Municipality, Chiny, 100191
- Jeszcze nie rekrutacja
- Peking University Third Hospital
-
Kontakt:
- Wen Tang
- E-mail: tangwen@126.com
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Chiny, 400010
- Jeszcze nie rekrutacja
- The Second Affiliated Hospital of Chongqing Medical University
-
Kontakt:
- Xiaohui Liao
- E-mail: 1263201771@qq.com
-
-
Guangdong
-
Guangzhou, Guangdong, Chiny, 510120
- Jeszcze nie rekrutacja
- Guangdong Provincial Hospital of Traditional Chinese Medicine
-
Kontakt:
- Xusheng Liu
- E-mail: liuxu801@126.com
-
-
Hebei
-
Shijiazhuang, Hebei, Chiny, 050051
- Jeszcze nie rekrutacja
- Hebei Medical University Third Hospital
-
Kontakt:
- Yanqing Chi
- E-mail: lilychi@sina.com
-
-
Heilongjiang
-
Harbin, Heilongjiang, Chiny, 150001
- Jeszcze nie rekrutacja
- The Second Affiliated Hospital of Harbin Medical University
-
Kontakt:
- Xuanyi Du
- E-mail: dxy_shennei@126.com
-
-
Henan
-
Zhengzhou, Henan, Chiny, 450003
- Jeszcze nie rekrutacja
- Henan Provincial People's Hospital
-
Kontakt:
- Fengmin Shao
- E-mail: fengminshao@126.com
-
-
Hubei
-
Wuhan, Hubei, Chiny, 430071
- Jeszcze nie rekrutacja
- Zhongnan Hospital of Wuhan University
-
Kontakt:
- Huiming Wang
- E-mail: 736238012@qq.com
-
-
Hunan
-
Changsha, Hunan, Chiny, 410013
- Jeszcze nie rekrutacja
- The Third XIANGYA Hospital of Central South University
-
Kontakt:
- Hao Zhang
- E-mail: Zhanghaoliaoqing@163.com
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, Chiny, 014010
- Jeszcze nie rekrutacja
- The First Affiliated Hospital of Baotou Medical College
-
Kontakt:
- Lei Nan
- E-mail: nanlei566@163.com
-
-
Jiangsu
-
Wuxi, Jiangsu, Chiny, 214023
- Jeszcze nie rekrutacja
- Wuxi People's Hospital
-
Kontakt:
- Liang Wang
- E-mail: wangliang_wuxi@126.com
-
-
Jilin
-
Changchun, Jilin, Chiny, 130041
- Jeszcze nie rekrutacja
- The Second Norman Bethune Hospital of Jilin University
-
Kontakt:
- Wenpeng Cui
- E-mail: wenpengcui@163.com
-
-
Shaanxi
-
Xi'an, Shaanxi, Chiny, 710061
- Jeszcze nie rekrutacja
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Kontakt:
- Jing Lv
- E-mail: drlvjing@163.com
-
-
Shandong
-
Qingdao, Shandong, Chiny, 266555
- Jeszcze nie rekrutacja
- The Affiliated Hospital of Qingdao University
-
Kontakt:
- Guangqun Xing
- E-mail: gqx99monash@163.com
-
Yantai, Shandong, Chiny, 264000
- Jeszcze nie rekrutacja
- Yantai YuHuangDing Hospital
-
Kontakt:
- Peng Li
- E-mail: yhdgcplipeng@163.com
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Chiny, 200233
- Jeszcze nie rekrutacja
- Shanghai Sixth People's Hospital
-
Kontakt:
- Niansong Wang
- E-mail: wangniansong2012@163.com
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Chiny, 300190
- Jeszcze nie rekrutacja
- Tianjin First Central Hospital
-
Kontakt:
- Wenxiu Chang
- E-mail: changwx@sina.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, Chiny, 310007
- Jeszcze nie rekrutacja
- Hangzhou Hospital of Traditional Chinese Medicine
-
Kontakt:
- Mengli Tong
- E-mail: 1994185637@qq.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Patient survival rates
Ramy czasowe: 6, 12, and 24 months
|
6, 12, and 24 months
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Quality of Life Scores (EQ-5D-5L)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 6, 12 and 24 months
|
Social functioning and reintegration assessed using the EQ-5D-5L
|
6, 12 and 24 months
|
|
Social Reintegration
Ramy czasowe: 6, 12 and 24 months
|
Social functioning and reintegration assessed using supplementary questionnaires
|
6, 12 and 24 months
|
|
Healthcare Resource Utilization (Direct Medical Costs)
Ramy czasowe: 6, 12, and 24 months
|
Assessment of healthcare resource utilization including hospitalization rate
|
6, 12, and 24 months
|
|
Healthcare Resource Utilization (Direct Medical Costs)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 6, 12, and 24 months
|
Assessment of healthcare resource utilization including total hospitalization costs
|
6, 12, and 24 months
|
|
Healthcare workforce utilization
Ramy czasowe: 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)
Ramy czasowe: 6, 12, and 24 months
|
Costs related to non-medical expenditures and productivity loss collected via patient questionnaires
|
6, 12, and 24 months
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of infection-related complications
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Procesy patologiczne
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby nerek
- Choroby Urologiczne
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Przewlekła choroba
- Atrybuty choroby
- Niewydolność nerek
- Stany patologiczne, oznaki i objawy
- Niewydolność nerek, przewlekła
- Niewydolność nerek, przewlekła
- Jakość opieki zdrowotnej, dostęp i ocena
- Techniki śledcze
- Metody epidemiologiczne
- Mechanizmy oceny opieki zdrowotnej
- Jakość opieki zdrowotnej
- Zdrowie publiczne
- Środowisko i zdrowie publiczne
- Badania epidemiologiczne
- Charakterystyka badania epidemiologicznego
- Badania kohortowe
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- BXU625422
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .