Assisted Peritoneal Dialysis: A Feasibility Study

Patients with End-Stage Kidney Disease (ESKD) wishing to choose Peritoneal Dialysis (PD) may not be able to perform this modality due to advanced age, physical function/dexterity, vision, cognition, mobility, or psychosocial issues. This intervention will seek to test the feasibility of a clinical support model to address these barriers.

Patients identified by their nephrologist as wishing to choose Peritoneal Dialysis (PD), but needing assistance, are referred to the research staff for discussion and consent.

Based on the assessment of the subject's nephrologist, PD staff, and researchers, the subject will receive assistance beyond the standard PD care offered in US dialysis centers. Such assistance will be provided for up to one visit/day, seven days/week, for up to three months. At the end of that time period, the subject will be able to perform PD independently, have identified a care provider, or have planned with his/her nephrologist for an alternative dialysis modality.

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease; End Stage Kidney Disease
• Intervention / Treatment: Other: Assistance to perform Peritoneal Dialysis (PD) at home

Detailed Description

A patient identified by his/her nephrologist or the WellBound dialysis staff as a candidate for Peritoneal Dialysis (PD) who meets the inclusion criteria will be referred to the research staff for a discussion of the study and consent. A referral to this program can come from any physician referring to participating centers.

• Each subject consented into the study receives the standard of care education and training for home PD, in addition to the usual insertion of a PD catheter.
• The subject is then transferred to home PD with an individualized assistance plan and research follow-up.
• The subject receives the assistance of up to one visit per day depending on the subject's needs, as assessed by the interdisciplinary team, the nephrologist, and the primary investigator or delegate.
• The assistance will be provided by a research associate who has undergone full training in the PD techniques required to assist the PD subject at home.
• Every 4 weeks the PI or delegate reviews the subject's progress with the nephrologist and nephrology nurse to assess further assistance needs.
• Total assistance of up to 3 months is provided after which the subject is either independent, has a care provider, or has developed a plan with his/her nephrologist for future dialysis care.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul N Bennett, Ph.D.; Phone Number: 650-521-2213; Email: bennettp@satellitehealth.com
• Study Contact Backup: Name: Veronica Legg, MS; Phone Number: 650-404-3736; Email: leggv@satellitehealth.com

Study Locations

• United States
  • California
    • Emeryville, California, United States, 94608
      • Recruiting
      • Satellite WellBound Emeryville
    • Fremont, California, United States, 94538
      • Recruiting
      • Satellite WellBound Fremont
    • Milpitas, California, United States, 95035
      • Recruiting
      • Satellite WellBound Milpitas
    • Mountain View, California, United States, 94040
      • Recruiting
      • Satellite WellBound Mountain View
    • San Jose, California, United States, 95125
      • Recruiting
      • Satellite WellBound San Jose
    • San Mateo, California, United States, 94403
      • Recruiting
      • Satellite WellBound San Mateo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Peritoneal Dialysis (PD) patients identified as needing staff-assistance:

1. Incident peritoneal dialysis patients from participating centers identified by referring nephrologists or PD staff to need the service.

   OR

2. Prevalent PD patients who experience a change in status, making them in need of the service.

Criteria for needing assistance: The patient has one of the following criteria that prevents him or her from an independent PD program as assessed by their nephrologist, and nephrology nurse: advanced age, physical function/dexterity, vision, cognition, mobility, psychosocial issues or other.

Exclusion Criteria:

1. Age less than 18 years
2. Unable to understand English (because of the need to complete the consent form and survey instruments which are available only in English).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; All patients who qualify for the study will receive the intervention	Other: Assistance to perform Peritoneal Dialysis (PD) at home; The patient receives assistance of up to one visit per day for three months depending on the patient's needs, as assessed by the interdisciplinary team, the nephrologist, and the primary investigator or delegate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the feasibility of an assisted PD program by assessing the need.	Number and proportion of patients needing the service (out of total new starts of PD).	Throughout the study, an average of two years
To explore the feasibility of an assisted PD program by assessing the types of need.	Categorize types of assisted tasks and length of assistance needed by participants in the program.	Throughout the study, an average of two years
To explore the feasibility of an assisted PD program by assessing acceptance.	Measure the number and rate of patients recruited.	Throughout the study, an average of two years
To explore the feasibility of an assisted PD program by measuring adherence.	Measure the number and rate of participants' adherence to and completion of the program.	Throughout the study, an average of two years
To explore the feasibility of an assisted PD program by assessing the outcome of participant Peritoneal Dialysis independence.	Measure the number of patients able to independently continue Peritoneal Dialysis out of all patients referred to the program.	Throughout the study, average of two years
To explore the feasibility of an assisted PD program by assessing any and all adverse events.	Collect all adverse events during the study.	Throughout the study, average of two years
To explore the feasibility of an assisted PD program by measuring the effect on the program on the participant's ability to maintain PD as the treatment modality.	Change in the number of patients who remain on Peritoneal dialysis after assistance as reflected in the dialysis unit records from 1 month to 12 months.	At 1, 2, 3, 6, and 12 months
To provide data to estimate the personnel costs of a US assisted PD program.	Measurement of the time and, thus, costs of personnel to conduct the assisted PD program.	Aggregated from the start to end of the study (estimated as two years)
To provide data to estimate the resources costs of a US assisted PD program.	Measurement of all non-personal costs to complete the study.	Aggregated from the start to end of the study (estimated as two years)
To identify the demographics of the population in need of assisted PD support.	Assessment of the baseline demographics of the patient as routinely collected in the dialysis record.	On referral into the study.
To identify the medical history of the population in need of assisted PD support.	Assessment of the medical history of the patient as routinely collected in the dialysis record.	Day one on the study
To identify the frailty level of the population in need of assisted PD support.	Measured by the clinical frailty scale. This ranges from 1 (very fit) to 9 (terminally ill).	Change from day 1 of home dialysis to 3 months (end of the intervention) .
To identify the patient activation level of the population in need of assisted PD support.	Measured by the Patient Activation Measure: PAM-13 survey. This is a 100 point scale with lower scores designating an individual with less ability to manage his/her health and healthcare.	Change from month 1 through month 3 (end of the intervention).
To identify the patient symptom level of the population in need of assisted PD support.	Measured by the Renal Patient Outcome Scale: IPOS-Renal survey which is composed of 11 questions on renal symptoms and patient issues with higher scores indicating greater distress.	Change from week 1 to month 3 (end of study).
To identify the patient satisfaction with an assisted PD program.	Measured by a simple LIkert Patient Satisfaction Scale ranging from 1 - 5 with higher results indicating greater satisfaction.	Change from 1 month to the end of the patient's participation in the study (up to 1 year).
To identify the staff's satisfaction with an assisted PD program.	Assessed by open ended questions at a staff focus group.	One time at the end of the program (approximately two years).

Collaborators and Investigators

• Sponsor: Satellite Healthcare

Publications and helpful links

General Publications

• Hussein WF, Bennett PN, Anwaar A, Atwal J, Legg V, Abra G, Zheng S, Pravoverov L, Schiller B. Implementation of a Staff-Assisted Peritoneal Dialysis Program in the United States: A Feasibility Study. Clin J Am Soc Nephrol. 2022 May;17(5):703-705. doi: 10.2215/CJN.00940122. Epub 2022 Apr 5. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2020
• Primary Completion (ANTICIPATED): November 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; End Stage Renal Disease (ESRD); End Stage Kidney Disease (ESKD)
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SIH123_Assisted PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No