Assisted Peritoneal Dialysis: A Feasibility Study

Last updated: September 21, 2021
Sponsor: Satellite Healthcare
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04319185
SIH123_Assisted PD
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

  1. Incident peritoneal dialysis patients from participating centers identified byreferring nephrologists or PD staff to need the service. OR
  2. Prevalent PD patients who experience a change in status, making them in need of theservice. Criteria for needing assistance: The patient has one of the following criteria thatprevents him or her from an independent PD program as assessed by their nephrologist, andnephrology nurse: advanced age, physical function/dexterity, vision, cognition, mobility,psychosocial issues or other.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 20
Study Start date:
September 11, 2020
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Satellite WellBound Emeryville

    Emeryville, California 94608
    United States

    Active - Recruiting

  • Satellite WellBound Fremont

    Fremont, California 94538
    United States

    Active - Recruiting

  • Satellite WellBound Milpitas

    Milpitas, California 95035
    United States

    Active - Recruiting

  • Satellite WellBound Mountain View

    Mountain View, California 94040
    United States

    Active - Recruiting

  • Satellite WellBound San Jose

    San Jose, California 95125
    United States

    Active - Recruiting

  • Satellite WellBound San Mateo

    San Mateo, California 94403
    United States

    Active - Recruiting

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