Assisted Peritoneal Dialysis: A Feasibility Study

NCT04319185 | Unknown

• 1 other identifier: SIH123_Assisted PD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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)

• 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)

• 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.

• 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

• 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) .

• 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).

• 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).

• 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).

• 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).

Study Arms (1)

Intervention

EXPERIMENTAL

All patients who qualify for the study will receive the intervention

Other: Assistance to perform Peritoneal Dialysis (PD) at home

Interventions

Assistance to perform Peritoneal Dialysis (PD) at home 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Satellite Healthcare: lead

Study Sites (6)

Satellite WellBound Emeryville

Emeryville, California, 94608, United States

RECRUITING

Satellite WellBound Fremont

Fremont, California, 94538, United States

RECRUITING

Satellite WellBound Milpitas

Milpitas, California, 95035, United States

RECRUITING

Satellite WellBound Mountain View

Mountain View, California, 94040, United States

RECRUITING

Satellite WellBound San Jose

San Jose, California, 95125, United States

RECRUITING

Satellite WellBound San Mateo

San Mateo, California, 94403, United States

RECRUITING

Related Publications (2)

• Hussein WF, Chen S, Bennett PN, Atwal J, Abra G, Weinhandl E, Zheng S, Pravoverov L, Schiller B. Description and outcomes of a staff-assisted peritoneal dialysis program in the United States. Perit Dial Int. 2025 Nov;45(6):344-352. doi: 10.1177/08968608241259607. Epub 2024 Jun 17.

  PMID: 38881397 DERIVED

• 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.

  PMID: 35383044 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wael F Hussein, MBBS

  Satellite Healthcare, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul N Bennett, Ph.D.

CONTACT

650-521-2213; bennettp@satellitehealth.com

Veronica Legg, MS

CONTACT

650-404-3736; leggv@satellitehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: March 24, 2020
• Study Start: September 11, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)