ESRDNCT05022225
Psychosocial Reasons for Transfer to In Center Hemodialysis in Home Dialysis Patients- A Focus Group Study
An observational study of ESRD, run by Satellite Healthcare at 1 site in United States.
Trial summary
Patients who start home dialysis take on an added responsibility and that can be challenging. The investigators are interested in studying the patient and care partner perspective on the challenges that the participants faced on home dialysis and what interventions could help support them better by holding focus group… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ESRD
- What is being tested?
- None. This is a qualitative interview study.
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 25 Jul 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ESRD patients at Satellite health care who transferred to ICHD from home dialysis in the last year and home dialysis patients who are identified as high risk for transfer to ICHD by the clinical team.
Who may be able to join
- Patients currently on home dialysis (maintenance peritoneal dialysis or home hemodialysis), preferably identified as high risk of transfer to in center HD at Satellite healthcare by the clinical team, OR their care partner
- Patients who transferred from home dialysis to ICHD in the last 12 (preferably 6) months, preferably those who had transferred mostly because of psychosocial reasons such as nonconducive living conditions, patient preference, the burden of treatment, loss of care partner, etc, OR their care partner.
- Age >=20 years
Who cannot join
- Lack of decision-making capacity
- Non English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Satellite Healthcare Inc
San Jose, California, 95128
About this study
Patients who start home dialysis take on an added responsibility and that can be challenging. The investigators are interested in studying the patient and care partner perspective on the challenges that the participants faced on home dialysis and what interventions could help support them better by holding focus group discussions.
Read the detailed description
Home dialysis has many advantages compared to in-center hemodialysis (ICHD) including better quality of life and lower healthcare costs. Transfer from home dialysis to ICHD is disruptive to the patients' lives and in some cases may be preventible. Patients do not infrequently transfer to ICHD due to psychosocial reasons, which may be multi-factorial and hard to capture.
The aim of this study is to explore patients' and care partners' perspectives and experiences of the psychosocial factors that make home dialysis challenging and that ultimately contribute to transfer to ICHD during focus group discussions. The investigators will ask them to describe issues that may compound patient and care partner burnout; for those who have already transferred to hemodialysis, the investigators will specifically ask what factors contributed to their transfer off of home dialysis. the investigators will also ask for feedback on what interventions may have helped to prevent the transfer and/or burnout.
- Understanding patient's perspectives and experiences will help the investigators improve patient experience and identify the gaps in health care delivery.
- Help plan interventions and scale-out a solution to identify patients experiencing challenges that put them at risk of transfer to ICHD.
- Lay the groundwork to develop surveys that can be used in the future.
- To enable a truly patient-centered care model, understanding the issues in more detail is critical.
- Conditions
- ESRD
- Being tested
- None. This is a qualitative interview study.
- Keywords
- home dialysis, Peritoneal dialysis, home hemodialysis, patient perspective
- 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.
None. This is a qualitative interview study.Other
There is no intervention in this study. This is a qualitative research study where participants will take part in focus group discussions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients and care partner experience on home dialysis
During the focus group discussion, the participants will be asked to account their experience on home dialysis and the challenges that they faced while on the modality. Since it is a qualitative study the responses will be grouped to identify any common themes.
Measured: At the time of focus group discussion
Secondary outcomes (2)
patient and care partner perspective on possible interventions
During the focus group discussion the participants will be asked if there were any interventions that were offered or if there are any interventions that would have helped support them better on home dialysis. Since it is a qualitative study the responses will be grouped to identify any common themes.
Measured: At the time of the focus group discussion
comparison between groups
Different themes between the participant responses will be compared after a thematic analysis.
Measured: At the time of focus group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start10 Aug 2021
- Primary completion31 Jan 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies 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
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael F Hussein, MBBS, Principal investigator, Satelite Health care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022225
- Sponsor's protocol ID
- SIH128_Transfer to ICHD
- Status last verified
- Jul 2022
- First submitted
- 13 Aug 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual person data will be available to anyone other than Satellite Healthcare Research employees.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Reasons for Transfer to In Center Hemodialysis in Home Dialysis Patients- A Focus Group Study
- ClinicalTrials.gov ID
- NCT05022225
- Acronym / sponsor ID
- SIH128_Transfer to ICHD
- Conditions
- ESRD
- Keywords
- home dialysis, Peritoneal dialysis, home hemodialysis, patient perspective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 26 Aug 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.
Patients who start home dialysis take on an added responsibility and that can be challenging. The investigators are interested in studying the patient and care partner perspective on the challenges that the participants faced on home dialysis and what interventions could help support them better by holding focus group discussions.
Detailed description
Home dialysis has many advantages compared to in-center hemodialysis (ICHD) including better quality of life and lower healthcare costs. Transfer from home dialysis to ICHD is disruptive to the patients' lives and in some cases may be preventible. Patients do not infrequently transfer to ICHD due to psychosocial reasons, which may be multi-factorial and hard to capture.
The aim of this study is to explore patients' and care partners' perspectives and experiences of the psychosocial factors that make home dialysis challenging and that ultimately contribute to transfer to ICHD during focus group discussions. The investigators will ask them to describe issues that may compound patient and care partner burnout; for those who have already transferred to hemodialysis, the investigators will specifically ask what factors contributed to their transfer off of home dialysis. the investigators will also ask for feedback on what interventions may have helped to prevent the transfer and/or burnout.
- Understanding patient's perspectives and experiences will help the investigators improve patient experience and identify the gaps in health care delivery.
- Help plan interventions and scale-out a solution to identify patients experiencing challenges that put them at risk of transfer to ICHD.
- Lay the groundwork to develop surveys that can be used in the future.
- To enable a truly patient-centered care model, understanding the issues in more detail is critical.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ESRD patients at Satellite health care who transferred to ICHD from home dialysis in the last year and home dialysis patients who are identified as high risk for transfer to ICHD by the clinical team.
Key inclusion criteria (3 listed)
- Patients currently on home dialysis (maintenance peritoneal dialysis or home hemodialysis), preferably identified as high risk of transfer to in center HD at Satellite healthcare by the clinical team, OR their care partner
- Patients who transferred from home dialysis to ICHD in the last 12 (preferably 6) months, preferably those who had transferred mostly because of psychosocial reasons such as nonconducive living conditions, patient preference, the burden of treatment, loss of care partner, etc, OR their care partner.
- Age >=20 years
Key exclusion criteria (2 listed)
- Lack of decision-making capacity
- Non English-speaking
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 |
|---|---|---|
| None. This is a qualitative interview study.There is no intervention in this study. This is a qualitative research study where participants will take part in focus group discussions. | Other | – |
Primary outcome
Patients and care partner experience on home dialysis
Time frame: At the time of focus group discussion
During the focus group discussion, the participants will be asked to account their experience on home dialysis and the challenges that they faced while on the modality. Since it is a qualitative study the responses will be grouped to identify any common themes.
2 secondary outcomes
patient and care partner perspective on possible interventions
Time frame: At the time of the focus group discussion
comparison between groups
Time frame: At the time of focus group
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 26 Jul 2022.
- Individual participant dataSharing planned: No. No individual person data will be available to anyone other than Satellite Healthcare Research employees.
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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
Satelite Health care
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 ESRD, 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 3 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: finished, as of the sponsor's last update on 26 Jul 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?
Patients and care partner experience on home dialysis (time frame: At the time of focus group discussion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2022.