Assisted Peritoneal Dialysis: A Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Kidney Disease End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A mixed-methods feasibility design using quantitative and qualitative techniques will be used to meet the aims of this study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

All patients who qualify for the study will receive the intervention

Group Type EXPERIMENTAL

Assistance to perform Peritoneal Dialysis (PD) at home

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No