Interactive Videoconferencing in the Provision of Remote Peritoneal Dialysis

NCT02428803 | Completed

• 1 other identifier: X141112004
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Home dialysis patients must be seen in a face to face visit on a monthly basis. For patients who live remotely these visits may impact their quality of life due to the amount of time needed to attend these visits. The central hypothesis is that implementation of telemedicine visits as a substitute for the 2 out of 3 monthly face-to-face visits over a 6 month period will improve quality of life as judged by the quality of life (QoL) indices Kidney Disease Quality of Life - Short Form and the Illness Intrusiveness Ratings Scale when compared to QoL scales taken during a time period when the patient is on standard of care.

Conditions

ESRD

Keywords

Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• Change in Kidney Disease Quality Life Short Form 36 Survey when compared from the standard of care portion of the study to the telemedicine portion of the study

  This outcome will determine the impact of telemedicine on quality of life as indicated two quality of life surveys.

  36 months

Secondary Outcomes (1)

• Composite endpoint of hospitalizations and peritonitis rates when comparing the time period on standard of care versus the time period of the telemedicine intervention.

  36 months

Interventions

Telemedicine OTHER

Patients will be administered the KDQOL-SF and the IIRS and will all start in the standard of care arm. During this time period the patients will receive 6 months of visits as per the usual standard of care. At the end of 6 months the KDQOL-SF and IIRS will again be administered. The patient will then transition to the telemedicine arm of the study for the duration of 6 months. During this time, the patient will come to the dialysis unit on a quarterly basis for a standard visit with labs being drawn in-center and for an in-center Kt/V. For the 2 months following the visit ,however, the patient will not be required to come to the dialysis unit. The monthly face to face and labs will be achieved remotely

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

UAB patients on peritoneal dialysis that are living in a different county other than Jefferson county and has been on stable therapy for 2 months.

You may qualify if:

• Age 19 or greater
• On Peritoneal Dialysis
• Living in a different county than that of the UAB Home Dialysis Unit ( Any county other than Jefferson County)
• Patients have to be stable on therapy for 2 months prior to enrollment

You may not qualify if:

• Living in Jefferson County

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (13)

• US Renal Data System: Bethesda, US Department of Public Health and Human Services, Public Health Service, National Institutes of Health, 2013

  BACKGROUND

• Tonelli M, Hemmelgarn B, Culleton B, Klarenbach S, Gill JS, Wiebe N, Manns B; Alberta Kidney Disease Network. Mortality of Canadians treated by peritoneal dialysis in remote locations. Kidney Int. 2007 Oct;72(8):1023-8. doi: 10.1038/sj.ki.5002443. Epub 2007 Jul 18.

  PMID: 17637709 BACKGROUND

• Nayak A, Karopadi A, Antony S, Sreepada S, Nayak KS. Use of a peritoneal dialysis remote monitoring system in India. Perit Dial Int. 2012 Mar-Apr;32(2):200-4. doi: 10.3747/pdi.2011.00124. No abstract available.

  PMID: 22383718 BACKGROUND

• Afolalu B, Troidle L, Osayimwen O, Bhargava J, Kitsen J, Finkelstein FO. Technique failure and center size in a large cohort of peritoneal dialysis patients in a defined geographic area. Perit Dial Int. 2009 May-Jun;29(3):292-6.

  PMID: 19458301 BACKGROUND

• Huisman RM, Nieuwenhuizen MG, Th de Charro F. Patient-related and centre-related factors influencing technique survival of peritoneal dialysis in The Netherlands. Nephrol Dial Transplant. 2002 Sep;17(9):1655-60. doi: 10.1093/ndt/17.9.1655.

  PMID: 12198219 BACKGROUND

• Guo A, Mujais S. Patient and technique survival on peritoneal dialysis in the United States: evaluation in large incident cohorts. Kidney Int Suppl. 2003 Dec;(88):S3-12. doi: 10.1046/j.1523-1755.2003.08801.x.

  PMID: 14870873 BACKGROUND

• Prakash S, Coffin R, Schold J, Lewis SA, Gunzler D, Stark S, Howard M, Rodgers D, Einstadter D, Sehgal AR. Travel distance and home dialysis rates in the United States. Perit Dial Int. 2014 Jan-Feb;34(1):24-32. doi: 10.3747/pdi.2012.00234.

  PMID: 24525595 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, Hatta M, Tanaka A, Moriwaki K, Oohama K, Kagawa K, Wada K, Suzuki H. Telemedicine system for home automated peritoneal dialysis. Adv Perit Dial. 2000;16:191-4.

  PMID: 11045291 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

• Fong E, Bargman JM, Chan CT. Cross-sectional comparison of quality of life and illness intrusiveness in patients who are treated with nocturnal home hemodialysis versus peritoneal dialysis. Clin J Am Soc Nephrol. 2007 Nov;2(6):1195-200. doi: 10.2215/CJN.02260507. Epub 2007 Oct 10.

  PMID: 17928469 BACKGROUND

• Diamant MJ, Young A, Gallo K, Xi W, Suri RS, Garg AX, Moist LM. Hemodialysis in a satellite unit: clinical performance target attainment and health-related quality of life. Clin J Am Soc Nephrol. 2011 Jul;6(7):1692-9. doi: 10.2215/CJN.07650810. Epub 2011 May 12.

  PMID: 21566106 BACKGROUND

• Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics. 1999 Feb;15(2):141-55. doi: 10.2165/00019053-199915020-00003.

  PMID: 10351188 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Eric Wallace, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Medicine - Nephrology

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

US (1)