Recruiting

Peritoneal DialysisAssisted Peritoneal Dialysis: A Feasibility Study

Sponsor:

Satellite Healthcare

Code:

NCT04319185

Conditions

End Stage Kidney Disease

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Assistance to perform Peritoneal Dialysis (PD) at home

Study Details

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.

Conditions

End Stage Kidney Disease

End Stage Renal Disease

Study ID

NCT04319185

Start date

Sep 11, 2020

Status verified date

Sep, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Nov 30, 2021

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention

All patients who qualify for the study will receive the intervention

Interventions

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.

Primary outcome measure

To explore the feasibility of an assisted PD program by assessing the need. [ Time Frame: Throughout the study, an average of two years ]
To explore the feasibility of an assisted PD program by assessing the types of need. [ Time Frame: Throughout the study, an average of two years ]
To explore the feasibility of an assisted PD program by assessing acceptance. [ Time Frame: Throughout the study, an average of two years ]
To explore the feasibility of an assisted PD program by measuring adherence. [ Time Frame: 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. [ Time Frame: Throughout the study, average of two years ]
To explore the feasibility of an assisted PD program by assessing any and all adverse events. [ Time Frame: 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. [ Time Frame: At 1, 2, 3, 6, and 12 months ]
To provide data to estimate the personnel costs of a US assisted PD program. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: On referral into the study. ]
To identify the medical history of the population in need of assisted PD support. [ Time Frame: Day one on the study ]
To identify the frailty level of the population in need of assisted PD support. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Change from week 1 to month 3 (end of study). ]
To identify the patient satisfaction with an assisted PD program. [ Time Frame: 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. [ Time Frame: One time at the end of the program (approximately two years). ]

Central Contacts and Locations

Central contacts

Paul N Bennett, Ph.D.

650-521-2213 bennettp@satellitehealth.com

Veronica Legg, MS

650-404-3736 leggv@satellitehealth.com

Locations

Satellite WellBound Emeryville

Recruiting

Emeryville, California, United States, 94608

Satellite WellBound Fremont

Recruiting

Fremont, California, United States, 94538

Satellite WellBound Milpitas

Recruiting

Milpitas, California, United States, 95035

Satellite WellBound Mountain View

Recruiting

Mountain View, California, United States, 94040

Satellite WellBound San Jose

Recruiting

San Jose, California, United States, 95125

Satellite WellBound San Mateo

Recruiting

San Mateo, California, United States, 94403

More Information

Sponsor

Satellite Healthcare

Last update posted

Sep 22, 2021

Last verified

Sep, 2021

Keywords

Peritoneal Dialysis
End Stage Renal Disease (ESRD)
End Stage Kidney Disease (ESKD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Satellite Healthcare on 2021-09-22.