Clinical trial NCT04319185: Assisted Peritoneal Dialysis: A Feasibility Study
Official title: Assisted Peritoneal Dialysis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Kidney Disease
End Stage Renal Disease
Keywords: Peritoneal Dialysis
End Stage Renal Disease (ESRD)
End Stage Kidney Disease (ESKD)
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A mixed-methods feasibility design using quantitative and qualitative techniques will be used to meet the aims of this study.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: To explore the feasibility of an assisted PD program by assessing the need.
timeFrame: Throughout the study, an average of two years
measure: To explore the feasibility of an assisted PD program by assessing the types of need.
timeFrame: Throughout the study, an average of two years
measure: To explore the feasibility of an assisted PD program by assessing acceptance.
timeFrame: Throughout the study, an average of two years
measure: To explore the feasibility of an assisted PD program by measuring adherence.
timeFrame: Throughout the study, an average of two years
measure: To explore the feasibility of an assisted PD program by assessing the outcome of participant Peritoneal Dialysis independence.
timeFrame: Throughout the study, average of two years
measure: To explore the feasibility of an assisted PD program by assessing any and all adverse events.
timeFrame: Throughout the study, average of two years
measure: 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.
timeFrame: At 1, 2, 3, 6, and 12 months
measure: To provide data to estimate the personnel costs of a US assisted PD program.
timeFrame: Aggregated from the start to end of the study (estimated as two years)
measure: To provide data to estimate the resources costs of a US assisted PD program.
timeFrame: Aggregated from the start to end of the study (estimated as two years)
measure: To identify the demographics of the population in need of assisted PD support.
timeFrame: On referral into the study.
measure: To identify the medical history of the population in need of assisted PD support.
timeFrame: Day one on the study
measure: To identify the frailty level of the population in need of assisted PD support.
timeFrame: Change from day 1 of home dialysis to 3 months (end of the intervention) .
measure: To identify the patient activation level of the population in need of assisted PD support.
timeFrame: Change from month 1 through month 3 (end of the intervention).
measure: To identify the patient symptom level of the population in need of assisted PD support.
timeFrame: Change from week 1 to month 3 (end of study).
measure: To identify the patient satisfaction with an assisted PD program.
timeFrame: Change from 1 month to the end of the patient's participation in the study (up to 1 year).
measure: To identify the staff's satisfaction with an assisted PD program.
timeFrame: One time at the end of the program (approximately two years).
Secondary outcomes:
Other outcomes:
Locations:
city: Emeryville
country: United States
facility: Satellite WellBound Emeryville
state: California
city: Fremont
country: United States
facility: Satellite WellBound Fremont
state: California
city: Milpitas
country: United States
facility: Satellite WellBound Milpitas
state: California
city: Mountain View
country: United States
facility: Satellite WellBound Mountain View
state: California
city: San Jose
country: United States
facility: Satellite WellBound San Jose
state: California
city: San Mateo
country: United States
facility: Satellite WellBound San Mateo
state: California
Study officials:
affiliation: Satellite Healthcare, Inc.
name: Wael F Hussein, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.