End Stage Kidney DiseaseNCT04319185
Assisted Peritoneal Dialysis: A Feasibility Study
A study testing Assistance to perform Peritoneal Dialysis (PD) at home in people with End Stage Kidney Disease and End Stage Renal Disease, run by Satellite Healthcare at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease, End Stage Renal Disease
- What is being tested?
- Assistance to perform Peritoneal Dialysis (PD) at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Satellite WellBound Emeryville
Emeryville, California, 94608
- Recruiting
Satellite WellBound Fremont
Fremont, California, 94538
- Recruiting
Satellite WellBound Milpitas
Milpitas, California, 95035
- Recruiting
Satellite WellBound Mountain View
Mountain View, California, 94040
- Recruiting
Satellite WellBound San Jose
San Jose, California, 95125
- Recruiting
Satellite WellBound San Mateo
San Mateo, California, 94403
About this study
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.
Read the 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.
- Conditions
- End Stage Kidney Disease, End Stage Renal Disease
- Being tested
- Assistance to perform Peritoneal Dialysis (PD) at home
- Keywords
- Peritoneal Dialysis, End Stage Renal Disease (ESRD), End Stage Kidney Disease (ESKD)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistance to perform Peritoneal Dialysis (PD) at homeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients who qualify for the study will receive the intervention Receives: Other: Assistance to perform Peritoneal Dialysis (PD) at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One time at the end of the program (approximately two years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start11 Sep 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael F Hussein, MBBS, Principal investigator, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319185
- Sponsor's protocol ID
- SIH123_Assisted PD
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38881397Hussein 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.
PubMed 35383044
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Peritoneal Dialysis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04319185
- Acronym / sponsor ID
- SIH123_Assisted PD
- Conditions
- End Stage Kidney Disease, End Stage Renal Disease
- Keywords
- Peritoneal Dialysis, End Stage Renal Disease (ESRD), End Stage Kidney Disease (ESKD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A mixed-methods feasibility design using quantitative and qualitative techniques will be used to meet the aims of this study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Assistance to perform Peritoneal Dialysis (PD) at homeAll patients who qualify for the study will receive the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assistance to perform Peritoneal Dialysis (PD) at homeThe 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. | Other | Intervention |
Primary outcome
To explore the feasibility of an assisted PD program by assessing the need.
Time frame: Throughout the study, an average of two years
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.
Time frame: Throughout the study, an average of two years
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.
Time frame: Throughout the study, an average of two years
Measure the number and rate of patients recruited.
To explore the feasibility of an assisted PD program by measuring adherence.
Time frame: Throughout the study, an average of two years
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.
Time frame: Throughout the study, average of two years
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.
Time frame: Throughout the study, average of two years
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.
Time frame: At 1, 2, 3, 6, and 12 months
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.
Time frame: Aggregated from the start to end of the study (estimated as two years)
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.
Time frame: Aggregated from the start to end of the study (estimated as two years)
Measurement of all non-personal costs to complete the study.
To identify the demographics of the population in need of assisted PD support.
Time frame: On referral into the study.
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.
Time frame: Day one on the study
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.
Time frame: Change from day 1 of home dialysis to 3 months (end of the intervention) .
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.
Time frame: Change from month 1 through month 3 (end of the intervention).
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.
Time frame: Change from week 1 to month 3 (end of study).
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.
Time frame: Change from 1 month to the end of the patient's participation in the study (up to 1 year).
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.
Time frame: One time at the end of the program (approximately two years).
Assessed by open ended questions at a staff focus group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 38881397Hussein 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.
- Derived from this study: PubMed 35383044Hussein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael F Hussein, MBBS principal investigator
Satellite Healthcare, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistance to perform Peritoneal Dialysis (PD) at home in people with End Stage Kidney Disease and End Stage Renal Disease, run by Satellite Healthcare at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul N Bennett, Ph.D. (650-521-2213, bennettp@satellitehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319185, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.