Assisted Peritoneal Dialysis: A Feasibility Study

End Stage Renal Disease Clinical Trial

Official title:

Assisted Peritoneal Dialysis: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319185
• Other study ID #: SIH123_Assisted PD
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Satellite Healthcare
• Contact: Paul N Bennett, Ph.D.
• Phone: 650-521-2213
• Email: bennettp[@]satellitehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• End Stage Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

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.

Locations

Country	Name	City	State
United States	Satellite WellBound Emeryville	Emeryville	California
United States	Satellite WellBound Fremont	Fremont	California
United States	Satellite WellBound Milpitas	Milpitas	California
United States	Satellite WellBound Mountain View	Mountain View	California
United States	Satellite WellBound San Jose	San Jose	California
United States	Satellite WellBound San Mateo	San Mateo	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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.
Primary	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
Primary	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) .
Primary	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).
Primary	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).
Primary	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).
Primary	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).