AzTrials
AzTrials

Chronic Kidney Disease Stage 5NCT04034966

Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis

A study testing Claria telemedicine device in people with Chronic Kidney Disease Stage 5 and Peritoneal Dialysis Complication, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Claria telemedicine device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
1 siteMexico
Study dates
20 Jun 2019to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over 18 years of age
  • Diagnosed with chronic kidney disease
  • Incident to automated peritoneal dialysis
  • Agree to sign informed consent

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI

    Mexico City, 06720

Other trials in Mexico

About this study

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.

Read the 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.

Being tested
Claria telemedicine device
Keywords
peritoneal dialysis, Claria, telemedicine
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Claria telemedicine deviceDevice

    Use of Claria telemedicine module, which stores patient information in the cloud.

Study groups in NCT04034966
Study groupRoleWhat they receive
ClariaActive comparatorThe 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.
Receives: Device: Claria telemedicine device
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MORTALITY RATE

    Number of patients who lose their lives for every 100 years / patient at risk. Deaths/100 years/patient at risk.

    Measured: 2 years

  2. DAYS OF HOSPITALIZATION

    Number of days in the hospital per 100 years / patient at risk. Days/100 years/patient at risk.

    Measured: 2 years

  3. DAYS OF PREVENTABLE HOSPITALIZATION

    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.

    Measured: 2 years

Secondary outcomes (1)
  1. COSTS

    These are the costs of using necessary services with the provision of dialysis and associated complications and comorbidities.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start20 Jun 2019
  3. Primary completionSep 2019 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04034966
Sponsor's protocol ID
R-2018-785-035
Status last verified
Jun 2019
First submitted
31 Oct 2018
Last updated
29 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.

    PubMed 17568785
  • Amato D, Alvarez-Aguilar C, Castaneda-Limones R, Rodriguez E, Avila-Diaz M, Arreola F, Gomez A, Ballesteros H, Becerril R, Paniagua R. Prevalence of chronic kidney disease in an urban Mexican population. Kidney Int Suppl. 2005 Aug;(97):S11-7. doi: 10.1111/j.1523-1755.2005.09702.x.

    PubMed 16014087
  • USRDS Annual Report 2015. Chapter 11: Medicare Expenditures for Persons with ESRD

  • Cortes-Sanabria L, Paredes-Cesena CA, Herrera-Llamas RM, Cruz-Bueno Y, Soto-Molina H, Pazarin L, Cortes M, Martinez-Ramirez HR. Comparison of cost-utility between automated peritoneal dialysis and continuous ambulatory peritoneal dialysis. Arch Med Res. 2013 Nov;44(8):655-61. doi: 10.1016/j.arcmed.2013.10.017. Epub 2013 Nov 8.

    PubMed 24211750
  • Informe al Ejecutivo Federal y al Congreso de la Unión 2015-2016V.6.1. Análisis del gasto en enfermedades crónico-degenerativas de alto impacto financiero para el IMSS. El Consejo Técnico del Instituto Mexicano del Seguro Social. Ciudad de México, junio de 2016

  • Harley KT, Streja E, Rhee CM, Molnar MZ, Kovesdy CP, Amin AN, Kalantar-Zadeh K. Nephrologist caseload and hemodialysis patient survival in an urban cohort. J Am Soc Nephrol. 2013 Oct;24(10):1678-87. doi: 10.1681/ASN.2013020123. Epub 2013 Aug 8.

    PubMed 23929773
  • Thomas-Hawkins C, Flynn L, Clarke SP. Relationships between registered nurse staffing, processes of nursing care, and nurse-reported patient outcomes in chronic hemodialysis units. Nephrol Nurs J. 2008 Mar-Apr;35(2):123-30, 145; quiz 131.

    PubMed 18472681
  • Balaskas EV, Ikonomopoulos D, Sioulis A, Dombros N, Kassimatis E, Bamichas G, Katsara I, Tourkantonis A. Survival and complications of 225 catheters used in continuous ambulatory peritoneal dialysis: one-center experience in Northern Greece. Perit Dial Int. 1999;19 Suppl 2:S167-71.

    PubMed 10406512
  • USRDS Annual Report 2015. Chapter 13: International Comparisons.

  • Pecoits-Filho R, Campos C, Cerdas-Calderon M, Fortes P, Jarpa C, Just P, Luconi P, Lugon JR, Pacheco A, Paniagua R, Rodriguez K, Sanabria M, Sciaraffia V, Velasco C, De Arteaga J. Policies and health care financing issues for dialysis in Latin America: extracts from the roundtable discussion on the economics of dialysis and chronic kidney disease. Perit Dial Int. 2009 Feb;29 Suppl 2:S222-6.

    PubMed 19270223
  • Jiwakanon S, Chiu YW, Kalantar-Zadeh K, Mehrotra R. Peritoneal dialysis: an underutilized modality. Curr Opin Nephrol Hypertens. 2010 Nov;19(6):573-7. doi: 10.1097/MNH.0b013e32833d67a3.

    PubMed 20639759
  • Mehrotra R. Choice of dialysis modality. Kidney Int. 2011 Nov;80(9):909-911. doi: 10.1038/ki.2011.262.

    PubMed 21997506
  • Lukowsky LR, Mehrotra R, Kheifets L, Arah OA, Nissenson AR, Kalantar-Zadeh K. Comparing mortality of peritoneal and hemodialysis patients in the first 2 years of dialysis therapy: a marginal structural model analysis. Clin J Am Soc Nephrol. 2013 Apr;8(4):619-28. doi: 10.2215/CJN.04810512. Epub 2013 Jan 10.

    PubMed 23307879
  • Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.

    PubMed 17785025
  • Nakamoto H, Nishida E, Ryuzaki M, Sone M, Yoshimoto M, Itagaki K. Blood pressure monitoring by cellular telephone in patients on continuous ambulatory peritoneal dialysis. Adv Perit Dial. 2004;20:105-10.

    PubMed 15384807

Questions about this trial

What is this clinical trial studying?

A study testing Claria telemedicine device in people with Chronic Kidney Disease Stage 5 and Peritoneal Dialysis Complication, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MORTALITY RATE (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04034966, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in