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

NCT04034966 | Unknown

• 1 other identifier: R-2018-785-035
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Stage 5; Peritoneal Dialysis Complication

Keywords

peritoneal dialysis; Claria; telemedicine

Outcome Measures

Primary Outcomes (3)

• MORTALITY RATE

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

  2 years

• DAYS OF HOSPITALIZATION

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

  2 years

• 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.

  2 years

Secondary Outcomes (1)

• COSTS

  2 years

Study Arms (2)

Claria

ACTIVE COMPARATOR

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.

Device: Claria telemedicine device

Control

NO INTERVENTION

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.

Interventions

Claria telemedicine device DEVICE

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

Claria

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

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

Mexico City, 06720, Mexico

Location

Related Publications (28)

• 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.

  PMID: 17568785 BACKGROUND

• 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.

  PMID: 16014087 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24211750 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23929773 BACKGROUND

• 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.

  PMID: 18472681 BACKGROUND

• 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.

  PMID: 10406512 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 19270223 BACKGROUND

• 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.

  PMID: 20639759 BACKGROUND

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

  PMID: 21997506 BACKGROUND

• 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.

  PMID: 23307879 BACKGROUND

• 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.

  PMID: 17785025 BACKGROUND

• 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.

  PMID: 15384807 BACKGROUND

• Edefonti A, Boccola S, Picca M, Paglialonga F, Ardissino G, Marra G, Ghio L, Parisotto MT. Treatment data during pediatric home peritoneal teledialysis. Pediatr Nephrol. 2003 Jun;18(6):560-4. doi: 10.1007/s00467-003-1147-8. Epub 2003 Apr 29.

  PMID: 12720083 BACKGROUND

• Cargill A, Watson AR. Telecare support for patients undergoing chronic peritoneal dialysis. Perit Dial Int. 2003 Jan-Feb;23(1):91-4. No abstract available.

  PMID: 12691517 BACKGROUND

• Ghio L, Boccola S, Andronio L, Adami D, Paglialonga F, Ardissino G, Edefonti A. A case study: telemedicine technology and peritoneal dialysis in children. Telemed J E Health. 2002 Winter;8(4):355-9. doi: 10.1089/15305620260507486.

  PMID: 12626104 BACKGROUND

• Lew SQ, Sikka N. Are patients prepared to use telemedicine in home peritoneal dialysis programs? Perit Dial Int. 2013 Nov-Dec;33(6):714-5. doi: 10.3747/pdi.2012.00203. No abstract available.

  PMID: 24335134 BACKGROUND

• Nakamoto H. Telemedicine system for patients on continuous ambulatory peritoneal dialysis. Perit Dial Int. 2007 Jun;27 Suppl 2:S21-6.

  PMID: 17556306 BACKGROUND

• Gallar P, Gutierrez M, Ortega O, Rodriguez I, Oliet A, Herrero JC, Mon C, Ortiz M, Molina A, Vigil A. [Telemedicine and follow up of peritoneal dialysis patients]. Nefrologia. 2006;26(3):365-71. Spanish.

  PMID: 16892826 BACKGROUND

• Dey V, Jones A, Spalding EM. Telehealth: Acceptability, clinical interventions and quality of life in peritoneal dialysis. SAGE Open Med. 2016 Oct 4;4:2050312116670188. doi: 10.1177/2050312116670188. eCollection 2016.

  PMID: 27757228 BACKGROUND

• Avila-Diaz M, Ventura MD, Valle D, Vicente-Martinez M, Garcia-Gonzalez Z, Cisneros A, Furlong MD, Gomez AM, Prado-Uribe MD, Amato D, Paniagua R. Inflammation and extracellular volume expansion are related to sodium and water removal in patients on peritoneal dialysis. Perit Dial Int. 2006 Sep-Oct;26(5):574-80.

  PMID: 16973513 BACKGROUND

• Paniagua R, Ventura MD, Avila-Diaz M, Hinojosa-Heredia H, Mendez-Duran A, Cueto-Manzano A, Cisneros A, Ramos A, Madonia-Juseino C, Belio-Caro F, Garcia-Contreras F, Trinidad-Ramos P, Vazquez R, Ilabaca B, Alcantara G, Amato D. NT-proBNP, fluid volume overload and dialysis modality are independent predictors of mortality in ESRD patients. Nephrol Dial Transplant. 2010 Feb;25(2):551-7. doi: 10.1093/ndt/gfp395. Epub 2009 Aug 12.

  PMID: 19679559 BACKGROUND

• Paniagua R, Ventura Mde J, Rodriguez E, Sil J, Galindo T, Hurtado ME, Alcantara G, Chimalpopoca A, Gonzalez I, Sanjurjo A, Barron L, Amato D, Mujais S. Impact of fill volume on peritoneal clearances and cytokine appearance in peritoneal dialysis. Perit Dial Int. 2004 Mar-Apr;24(2):156-62.

  PMID: 15119636 BACKGROUND

• Fischbach M, Issad B, Dubois V, Taamma R. The beneficial influence on the effectiveness of automated peritoneal dialysis of varying the dwell time (short/long) and fill volume (small/large): a randomized controlled trial. Perit Dial Int. 2011 Jul-Aug;31(4):450-8. doi: 10.3747/pdi.2010.00146. Epub 2011 Mar 31.

  PMID: 21454393 BACKGROUND

• Ronksley PE, Hemmelgarn BR, Manns BJ, Wick J, James MT, Ravani P, Quinn RR, Scott-Douglas N, Lewanczuk R, Tonelli M. Potentially Preventable Hospitalization among Patients with CKD and High Inpatient Use. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):2022-2031. doi: 10.2215/CJN.04690416. Epub 2016 Oct 6.

  PMID: 27821636 BACKGROUND

• Paniagua R, Ramos A, Fabian R, Lagunas J, Amato D. Chronic kidney disease and dialysis in Mexico. Perit Dial Int. 2007 Jul-Aug;27(4):405-9.

  PMID: 17602147 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabio Salamanca, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 750 Patients will be cluster randomized.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: July 29, 2019
• Study Start: June 20, 2019
• Primary Completion: September 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 29, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)