Clinical trial NCT04034966: Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis
Official title: Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Stage 5
Peritoneal Dialysis Complication
Keywords: peritoneal dialysis
Claria
telemedicine
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-07-29
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Project will consist in the conventional clinical treatment of the APD patient cared for in IMSS regarding the kind of dialysis solution, handling of laboratory and office procedures, as well as the handling of complications. One arm will utilize the Claria device, and the other will utilize normal treatment procedures.

The APD device in the control group will be called Claria® (Baxter, S.A. de C.V.) without the telemedicine device, and in the intervention group it will be the same device with the telemedicine module. Handling will be done according to the basic operating instructions established by the manufacturer.

According to the preliminary analysis of the flow of patients in PD indicated in the above paragraphs, recruitment of the sample size will not represent a problem. Infrastructure available in both technical and experienced human resources makes the study feasible.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

The facility of electronic communication has empowered the advantages of PD; with the use of telemedicine systems the rate of hospitalization has been reduced from 5.7 to 2.2, resulting in lower costs. One worry behind these efforts is knowing if the patients are prepared to join these systems. Luckily, the results of some surveys indicate that the degree of acceptance is high.

Telemedicine systems applied to PD include telephone devices with connection to land phones, tablets or teleconferences via the network. In Japan, telemedicine is used to monitor blood pressure, heart frequency, urinary volume or serum glucose, and in Spain it has been used for teleconferences, for clinical visits and audiovisual presentations to re-train patients. In Canada, contact through tablets favored communication between patients and health staff and, through the introduction of alerts in structured interviews; a significant number of hospital visits were avoided. In addition, they obtained a high level of patient satisfaction with the system.

Even when APD is an effective, safe procedure for treating patients with ESRD, the nephrologist depends on an important number of data that the patient should offer in order to write a prescription adjusted to the clinical conditions of each case. Some very illustrative aspects are, for example:

1. Ultrafiltration and total liquid removal (dialysis + urine) are crucial data to prescribe osmolarity and glucose content in dialysate. According to the clinical practice guides, there should be a minimum volume of 1.0 L/day, without forgetting that each mL of ultrafiltration is associated with the absorption of an important amount of glucose, with the consequent metabolic cost.
2. The volume of infused liquid should be adjusted to the body surface area of the patient, and should take into account that the total volume in the peritoneum has an additional increase from the ultrafiltration obtained. This should be achieved without exceeding the patient's tolerance and without forcing the generation of inflammatory stimuli.
3. In general, treatment adherence is estimated by the monthly consumption of dialysis solutions and patient self-reporting. However, the two procedures contain a large amount of subjectivity.
4. Adjustment or prescription of automated peritoneal dialysis (APD) requires calculation of the effective time of presence of the solutions in the cavity; that is, from the start of infusion to the end of drainage, discounting transit time.

All these data are impossible to obtain in a nocturnal treatment without the support of telemedicine. One aspect of great importance comes from the lack of achieving prescription goals, which negatively impacts clinical outcomes and incurs additional costs for unscheduled doctor visits and treatment of complications that are preventable through closer follow-up, such as the case of fluid overload through lack of ultrafiltration and symptoms of uremic syndrome from insufficient dialysis.

Potentially preventable hospitalization is understood as hospitalizations caused by ambulatory handling. It is about clinical conditions that can be prevented with good handling externally and that are recognized as indicators of efficiency in ambulatory handling. For the case of this project, in which telemedicine is expected to help make dialysis and ultrafiltration more efficient, potentially preventable hospitalizations will be considered in manifestations of uremic syndrome, hyperkalemia, and those derived from liquid overload, such as: edema, hypertension and heart failure.

Before the impossibility of obtaining complete, objective information necessary for the prescription of APD and adequate management of the patient, APD machines have incorporated a telemedicine module that recovers information on movement and volume of dialysis solution, glucose concentration, and in addition to objectively measuring treatment adherence. This new technology is already available, but its use in the "real world" has not been evaluated. Having this information in the investigator's medium is necessary, given that PD treatment predominates, especially in IMSS, which is the institution on which the weight of ESRD in the country rests.

Eligibility criteria: Inclusion Criteria: 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: MORTALITY RATE
timeFrame: 2 years
measure: DAYS OF HOSPITALIZATION
timeFrame: 2 years
measure: DAYS OF PREVENTABLE HOSPITALIZATION
timeFrame: 2 years
Secondary outcomes:
measure: COSTS
timeFrame: 2 years
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Fabio Salamanca, PhD
role: STUDY_CHAIR
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