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Assisted Peritoneal Dialysis: A Feasibility Study

Primary Purpose

End Stage Kidney Disease, End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assistance to perform Peritoneal Dialysis (PD) at home
Sponsored by
Satellite Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Kidney Disease focused on measuring Peritoneal Dialysis, End Stage Renal Disease (ESRD), End Stage Kidney Disease (ESKD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Satellite WellBound EmeryvilleRecruiting
  • Satellite WellBound FremontRecruiting
  • Satellite WellBound MilpitasRecruiting
  • Satellite WellBound Mountain ViewRecruiting
  • Satellite WellBound San JoseRecruiting
  • Satellite WellBound San MateoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

All patients who qualify for the study will receive the intervention

Outcomes

Primary Outcome Measures

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).
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.
To explore the feasibility of an assisted PD program by assessing acceptance.
Measure the number and rate of patients recruited.
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.
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.
To explore the feasibility of an assisted PD program by assessing any and all adverse events.
Collect all adverse events during the study.
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.
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.
To provide data to estimate the resources costs of a US assisted PD program.
Measurement of all non-personal costs to complete the study.
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.
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.
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).
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.
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.
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.
To identify the staff's satisfaction with an assisted PD program.
Assessed by open ended questions at a staff focus group.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2020
Last Updated
September 21, 2021
Sponsor
Satellite Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04319185
Brief Title
Assisted Peritoneal Dialysis: A Feasibility Study
Official Title
Assisted Peritoneal Dialysis: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satellite Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease, End Stage Renal Disease
Keywords
Peritoneal Dialysis, End Stage Renal Disease (ESRD), End Stage Kidney Disease (ESKD)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A mixed-methods feasibility design using quantitative and qualitative techniques will be used to meet the aims of this study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
All patients who qualify for the study will receive the intervention
Intervention Type
Other
Intervention Name(s)
Assistance to perform Peritoneal Dialysis (PD) at home
Intervention Description
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 Information:
Title
To explore the feasibility of an assisted PD program by assessing the need.
Description
Number and proportion of patients needing the service (out of total new starts of PD).
Time Frame
Throughout the study, an average of two years
Title
To explore the feasibility of an assisted PD program by assessing the types of need.
Description
Categorize types of assisted tasks and length of assistance needed by participants in the program.
Time Frame
Throughout the study, an average of two years
Title
To explore the feasibility of an assisted PD program by assessing acceptance.
Description
Measure the number and rate of patients recruited.
Time Frame
Throughout the study, an average of two years
Title
To explore the feasibility of an assisted PD program by measuring adherence.
Description
Measure the number and rate of participants' adherence to and completion of the program.
Time Frame
Throughout the study, an average of two years
Title
To explore the feasibility of an assisted PD program by assessing the outcome of participant Peritoneal Dialysis independence.
Description
Measure the number of patients able to independently continue Peritoneal Dialysis out of all patients referred to the program.
Time Frame
Throughout the study, average of two years
Title
To explore the feasibility of an assisted PD program by assessing any and all adverse events.
Description
Collect all adverse events during the study.
Time Frame
Throughout the study, average of two years
Title
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.
Description
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.
Time Frame
At 1, 2, 3, 6, and 12 months
Title
To provide data to estimate the personnel costs of a US assisted PD program.
Description
Measurement of the time and, thus, costs of personnel to conduct the assisted PD program.
Time Frame
Aggregated from the start to end of the study (estimated as two years)
Title
To provide data to estimate the resources costs of a US assisted PD program.
Description
Measurement of all non-personal costs to complete the study.
Time Frame
Aggregated from the start to end of the study (estimated as two years)
Title
To identify the demographics of the population in need of assisted PD support.
Description
Assessment of the baseline demographics of the patient as routinely collected in the dialysis record.
Time Frame
On referral into the study.
Title
To identify the medical history of the population in need of assisted PD support.
Description
Assessment of the medical history of the patient as routinely collected in the dialysis record.
Time Frame
Day one on the study
Title
To identify the frailty level of the population in need of assisted PD support.
Description
Measured by the clinical frailty scale. This ranges from 1 (very fit) to 9 (terminally ill).
Time Frame
Change from day 1 of home dialysis to 3 months (end of the intervention) .
Title
To identify the patient activation level of the population in need of assisted PD support.
Description
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.
Time Frame
Change from month 1 through month 3 (end of the intervention).
Title
To identify the patient symptom level of the population in need of assisted PD support.
Description
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.
Time Frame
Change from week 1 to month 3 (end of study).
Title
To identify the patient satisfaction with an assisted PD program.
Description
Measured by a simple LIkert Patient Satisfaction Scale ranging from 1 - 5 with higher results indicating greater satisfaction.
Time Frame
Change from 1 month to the end of the patient's participation in the study (up to 1 year).
Title
To identify the staff's satisfaction with an assisted PD program.
Description
Assessed by open ended questions at a staff focus group.
Time Frame
One time at the end of the program (approximately two years).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Peritoneal Dialysis (PD) patients identified as needing staff-assistance: Incident peritoneal dialysis patients from participating centers identified by referring nephrologists or PD staff to need the service. OR 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: Age less than 18 years Unable to understand English (because of the need to complete the consent form and survey instruments which are available only in English).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul N Bennett, Ph.D.
Phone
650-521-2213
Email
bennettp@satellitehealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Legg, MS
Phone
650-404-3736
Email
leggv@satellitehealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael F Hussein, MBBS
Organizational Affiliation
Satellite Healthcare, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satellite WellBound Emeryville
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Individual Site Status
Recruiting
Facility Name
Satellite WellBound Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
Satellite WellBound Milpitas
City
Milpitas
State/Province
California
ZIP/Postal Code
95035
Country
United States
Individual Site Status
Recruiting
Facility Name
Satellite WellBound Mountain View
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Name
Satellite WellBound San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95125
Country
United States
Individual Site Status
Recruiting
Facility Name
Satellite WellBound San Mateo
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35383044
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.
Results Reference
derived

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Assisted Peritoneal Dialysis: A Feasibility Study

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