End Stage Renal Disease on DialysisHOMENCT04806126
Evaluation of a Virtual Home Dialysis Mentoring Program (Home)
An observational study of End Stage Renal Disease on Dialysis and Home Dialysis, run by Satellite Healthcare at 1 site in United States.
Trial summary
The Investigator plans to establish a virtual platform for home dialysis physician mentoring with the intent to: 1. Formulate a practical, interactive, virtual curriculum in home dialysis 2. Provide dedicated video conferences in home dialysis mentorship 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease on Dialysis, Home Dialysis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 31 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Physicians credentialed at Satellite Healthcare will be eligible to participate along with nephrology fellows from training programs affiliated with credentialed physicians.
Who may be able to join
- Credentialed physicians at Satellite Healthcare
- Nephrology fellows at nephrology training program affiliated with Satellite Healthcare credentialed physician
Who cannot join
- Any person who does not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Satellite Healthcare, Inc.
San Jose, California, 95128
About this study
The Investigator plans to establish a virtual platform for home dialysis physician mentoring with the intent to:
- Formulate a practical, interactive, virtual curriculum in home dialysis
- Provide dedicated video conferences in home dialysis mentorship
- Measure knowledge awareness and attitudes towards home dialysis
Read the detailed description
Home-based kidney replacement therapy offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Globally, there is an increased awareness of home dialysis. However, there is a lack of mentoring centers to support new programs and/or nephrologists to initiate and grow home dialysis.1, 2 Critical prerequisites for a successful mentoring relationship include:
- Established excellence in home dialysis in the mentor center
- Willingness from both mentors and mentees to participate in the program
- Engaging, high quality clinical content, including sharing of best practices
- Lack of system barriers to establish home dialysis
- Dedicated metrics to measure success of the program
The Investigator plans to establish a virtual platform with the intent to:
- Formulate a practical, interactive, virtual curriculum in home dialysis
- Provide dedicated video conferences in home dialysis mentorship
- Measure knowledge awareness and attitudes towards home dialysis
The Investigator hypothesizes that an effective, sustained mentorship program will increase knowledge and awareness of home dialysis and will ultimately enhance overall home dialysis adoption.
- Conditions
- End Stage Renal Disease on Dialysis, Home Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Mentoring Program Participants | Physicians credentialed at Satellite Healthcare will be eligible to participate along with nephrology fellows from training programs affiliated with credentialed physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in participants' self-reported knowledge awareness.
The change in participants' self-reported knowledge awareness (as assessed by self- reported expertise rating).
Measured: through study completion, an average of 1 year
The change in participants' perception of home dialysis adoption
The change in participants' perception of home dialysis adoption as assessed by the percentage of home dialysis patients relative to conventional in-center hemodialysis at baseline versus the end of the study.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Number of registered participants
Number of physicians who register for the program
Measured: through study completion, an average of 1 year
Number of participants attending each session
Number of physicians who participate in each mentoring Session
Measured: through study completion, an average of 1 year
Change in the percentage of patients using home dialysis
Change between baseline and end of study in the number of home dialysis patients
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start19 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806126
- Sponsor's protocol ID
- SP132_Home
- Acronym
- HOME
- Status last verified
- May 2022
- First submitted
- 9 Mar 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehrotra R, Blake P, Berman N, Nolph KD. An analysis of dialysis training in the United States and Canada. Am J Kidney Dis. 2002 Jul;40(1):152-60. doi: 10.1053/ajkd.2002.33924.
PubMed 12087573Liebman SE, Moore CA, Monk RD, Rizvi MS. What Are We Doing? A Survey of United States Nephrology Fellowship Program Directors. Clin J Am Soc Nephrol. 2017 Mar 7;12(3):518-523. doi: 10.2215/CJN.06530616. Epub 2016 Dec 5.
PubMed 27920031Becevic M, Mutrux R, Edison K. Show-Me ECHO: Complex Disease Care Capacity-Building Telehealth Program. Stud Health Technol Inform. 2016;226:233-6.
PubMed 27350513Lewiecki EM, Rochelle R, Bouchonville MF 2nd, Chafey DH, Olenginski TP, Arora S. Leveraging Scarce Resources With Bone Health TeleECHO to Improve the Care of Osteoporosis. J Endocr Soc. 2017 Nov 6;1(12):1428-1434. doi: 10.1210/js.2017-00361. eCollection 2017 Dec 1.
PubMed 29264466King AM, Gottlieb M, Mitzman J, Dulani T, Schulte SJ, Way DP. Flipping the Classroom in Graduate Medical Education: A Systematic Review. J Grad Med Educ. 2019 Feb;11(1):18-29. doi: 10.4300/JGME-D-18-00350.2.
PubMed 30805092
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Virtual Home Dialysis Mentoring Program (Home)
- ClinicalTrials.gov ID
- NCT04806126
- Acronym / sponsor ID
- HOME / SP132_Home
- Conditions
- End Stage Renal Disease on Dialysis, Home Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Mar 2021 (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.
The Investigator plans to establish a virtual platform for home dialysis physician mentoring with the intent to:
- Formulate a practical, interactive, virtual curriculum in home dialysis
- Provide dedicated video conferences in home dialysis mentorship
- Measure knowledge awareness and attitudes towards home dialysis
Detailed description
Home-based kidney replacement therapy offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Globally, there is an increased awareness of home dialysis. However, there is a lack of mentoring centers to support new programs and/or nephrologists to initiate and grow home dialysis.1, 2 Critical prerequisites for a successful mentoring relationship include:
- Established excellence in home dialysis in the mentor center
- Willingness from both mentors and mentees to participate in the program
- Engaging, high quality clinical content, including sharing of best practices
- Lack of system barriers to establish home dialysis
- Dedicated metrics to measure success of the program
The Investigator plans to establish a virtual platform with the intent to:
- Formulate a practical, interactive, virtual curriculum in home dialysis
- Provide dedicated video conferences in home dialysis mentorship
- Measure knowledge awareness and attitudes towards home dialysis
The Investigator hypothesizes that an effective, sustained mentorship program will increase knowledge and awareness of home dialysis and will ultimately enhance overall home dialysis adoption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Mentoring Program Participants | – | –Physicians credentialed at Satellite Healthcare will be eligible to participate along with nephrology fellows from training programs affiliated with credentialed physicians. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians credentialed at Satellite Healthcare will be eligible to participate along with nephrology fellows from training programs affiliated with credentialed physicians.
Key inclusion criteria (2 listed)
- Credentialed physicians at Satellite Healthcare
- Nephrology fellows at nephrology training program affiliated with Satellite Healthcare credentialed physician
Key exclusion criteria (1 listed)
- Any person who does not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change in participants' self-reported knowledge awareness.
Time frame: through study completion, an average of 1 year
The change in participants' self-reported knowledge awareness (as assessed by self- reported expertise rating).
The change in participants' perception of home dialysis adoption
Time frame: through study completion, an average of 1 year
The change in participants' perception of home dialysis adoption as assessed by the percentage of home dialysis patients relative to conventional in-center hemodialysis at baseline versus the end of the study.
3 secondary outcomes
Number of registered participants
Time frame: through study completion, an average of 1 year
Number of participants attending each session
Time frame: through study completion, an average of 1 year
Change in the percentage of patients using home dialysis
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Background: PubMed 12087573Mehrotra R, Blake P, Berman N, Nolph KD. An analysis of dialysis training in the United States and Canada. Am J Kidney Dis. 2002 Jul;40(1):152-60. doi: 10.1053/ajkd.2002.33924.
- Background: PubMed 27920031Liebman SE, Moore CA, Monk RD, Rizvi MS. What Are We Doing? A Survey of United States Nephrology Fellowship Program Directors. Clin J Am Soc Nephrol. 2017 Mar 7;12(3):518-523. doi: 10.2215/CJN.06530616. Epub 2016 Dec 5.
- Background: PubMed 27350513Becevic M, Mutrux R, Edison K. Show-Me ECHO: Complex Disease Care Capacity-Building Telehealth Program. Stud Health Technol Inform. 2016;226:233-6.
- Background: PubMed 29264466Lewiecki EM, Rochelle R, Bouchonville MF 2nd, Chafey DH, Olenginski TP, Arora S. Leveraging Scarce Resources With Bone Health TeleECHO to Improve the Care of Osteoporosis. J Endocr Soc. 2017 Nov 6;1(12):1428-1434. doi: 10.1210/js.2017-00361. eCollection 2017 Dec 1.
- Background: PubMed 30805092King AM, Gottlieb M, Mitzman J, Dulani T, Schulte SJ, Way DP. Flipping the Classroom in Graduate Medical Education: A Systematic Review. J Grad Med Educ. 2019 Feb;11(1):18-29. doi: 10.4300/JGME-D-18-00350.2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease on Dialysis and Home Dialysis, run by Satellite Healthcare at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in participants' self-reported knowledge awareness. (time frame: through study completion, an average of 1 year). The study lists 2 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 NCT04806126, which also lists 5 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 20 May 2022.