Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- DAYS OF HOSPITALIZATION
研究概览
简要总结
Peritoneal dialysis (PD) technology is available but has not been tested in the real world. Therefore, the aim of this study is to test the utility of telemedicine in reducing mortality, hospitalizations, unscheduled visits, and cost derived from preventable complications. Incident patients to PD treatment will be followed from various hospitals in Mexico City and Guadalajara. Direct medical costs will be evaluated, along with unplanned hospital visits and complications over 2 years using the Claria telemedicine apparatus from Baxter Laboratories.
详细描述
Study Background & Rationale: (background information including previous studies as applicable )
Chronic kidney disease (CKD) is a growing problem world-wide which increases in parallel with some risk factors such as chronic diseases, mainly diabetes mellitus and hypertension. CKD imposes elevated costs both from the standpoint of human resources and hospital infrastructure, and above all in the economic aspect. In the United States, the cost of CKD equals more than 30 billion USD a year to care for a population of 450,000 patients, which means an elevated cost per patient per year. Mexico does not have precise statistics but it is estimated that the burden of the disease is higher than that faced by other health institutions in any of the therapeutic modalities. For IMSS, chronic kidney disease is found among the six diseases that cause the greatest expenses, datum that is magnified when considering that the current population in any dialysis program consists of only 60,000 patients. On the other hand, the number of nephrologists is insufficient to care for the patients, considering that the proportion recommended is 100 patients per nephrologist in dialysis programs. In IMSS, these proportions are greatly surpassed, and the need to increase human resources or use alternative technologies to ease the task is evident.
Since its introduction at the end of the 70's, peritoneal dialysis (PD) has been consolidated in many countries as a viable, long-term substitutive therapy for renal function. Frequency of use of PD in patients with end-stage renal disease (ESRD) has broad variations, from zero in some regions of France and Japan to 40% in the United Kingdom, 60% in Mexico, and 80% in Hong Kong.
In terms of outcomes, PD and hemodialysis (HD) are comparable. Mortality in PD is similar and even less than in HD, and the greatest advantage of PD over HD is its home application and simplified technique, since it gives the patient total autonomy for daily life. This advantage is even greater with nocturnal automated systems, or automated PD (APD).
In recent years, the concept of "telemedicine" has been developed, term that is used to name all electronic transfers of data, audio and video between the health team and patients, with the purpose of consultation, examination or performing long-distance medical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
750 Patients will be cluster randomized.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitals will be randomly assigned to control (without telemedicine device) or intervention groups (with telemedicine device). Hospitals will be selected and matched according their basic infrastructure (Outpatient dialysis clinic, Emergency Room, Laboratory and Radiology Departments, Hospitalization Facility, accessibility to the internet and direct telephone communication with the patient and/or contact or person in charge of the patient), as well as Human Resources (Nephrologist, Internist, specialists to attend to the most frequent complications of PD, Nurses trained in PD, and Social Workers), and availability of a structured PD Program (Manuals, Supervised training programs for patients and caregivers, Registers for peritonitis, technique failure, and mortality rates).
- •Inclusion criteria
- •Over 18 years of age
- •Diagnosed with chronic kidney disease
- •Incident to automated peritoneal dialysis
- •Agree to sign informed consent
排除标准
- •seropositive for HIV, hepatitis B or C, with cancer
- •in treatment with immunosuppressors or with acute complications in the 30 days previous to recruitment.
- •patients who voluntarily withdraw from the study, who change residence or who lose social security coverage.
研究组 & 干预措施
Claria
The APD device in the control group will be called Claria® (Baxter, S.A. de C.V.) with the telemedicine module. The telemedicine module is the platform for storing patient information directly from the PD machine. Handling will be done according to the basic operating instructions established by the manufacturer.
干预措施: Claria telemedicine device (Device)
Control
The APD device in the control group will be called Claria® (Baxter, S.A. de C.V.) without the telemedicine device. the device is used for automated peritoneal dialysis. Handling will be done according to the basic operating instructions established by the manufacturer.
结局指标
主要结局
DAYS OF HOSPITALIZATION
时间窗: 2 years
Number of days in the hospital per 100 years / patient at risk. Days/100 years/patient at risk.
DAYS OF PREVENTABLE HOSPITALIZATION
时间窗: 2 years
Number of days in the hospital for causes that can be corrected with efficient PD for every 100 years / patient at risk. Days/100 years/patient at risk.
MORTALITY RATE
时间窗: 2 years
Number of patients who lose their lives for every 100 years / patient at risk. Deaths/100 years/patient at risk.
次要结局
- COSTS(2 years)