Home DialysisNCT04435873
Assessing Patient-Reported Experience of Care for Home Dialysis (ASPIRED)
An observational study of Home Dialysis and End Stage Renal Disease, run by Satellite Healthcare at 32 sites in United States.
Trial summary
Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD), represent alternatives to conventional in-center hemodialysis (HD) that for some patients may be better aligned with preferences regarding the integration of dialysis treatments into their lives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Dialysis, End Stage Renal Disease
- What is being tested?
- Survey using "Your Home Dialysis Care Experience" tool.
- How many people
- 513 participants
- Where
- 32 sitesUnited States
- Study dates
- 17 Jul 2020to 6 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Target population is composed of those individuals receiving Home Dialysis care at Satellite Healthcare facilities,
Who may be able to join
- Patients receiving care for home dialysis at a facility that provides care for >= 3 patients at the time of cohort identification.
Who cannot join
- Age < 18 years
- Patients receiving care for home dialysis at the facility for less than 3 months
- Institutionalized (senior nursing facility/multi-resident facility) or Hospice care patients
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Satellite WellBound of South Austin
Austin, Texas, 78744
Satellite WellBound of Austin
Austin, Texas, 78758
Satellite WellBound of Daly City
Daly City, California, 94014
Satellite Wellbound of Emeryville
Emeryville, California, 94608
Satellite Dialysis Folsom
Folsom, California, 95630
Satellite Wellbound of Fremont
Fremont, California, 94538
Satellite Healthcare Gilroy
Gilroy, California, 95020
Satellite Healthcare Larkspur
Greenbrae, California, 94904
Satellite Healthcare Laguna Hills
Laguna Hills, California, 92653
Satellite Healthcare Laredo South
Laredo, Texas, 78040
Satellite Wellbound of Memphis
Memphis, Tennessee, 38117
Satellite Healthcare Merced
Merced, California, 95384
Satellite WellBound of Milpitas
Milpitas, California, 95035
Satellite WellBound of Modesto
Modesto, California, 95354
Satellite WellBound of North Modesto
Modesto, California, 95356
Satellite WellBound of Mountain View
Mountain View, California, 94040
Satellite Healthcare Orange
Orange, California, 92868
Satellite WellBound of Sacramento
Sacramento, California, 95821
Satellite WellBound of Sacramento University
Sacramento, California, 95825
Satellite Healthcare Sacramento
Sacramento, California, 95834
Satellite Healthcare San Carlos
San Carlos, California, 94070
Satellite WellBound of San Francisco
San Francisco, California, 94109
Satellite WellBound of San Jose
San Jose, California, 95125
Satellite WellBound of San Leandro
San Leandro, California, 94577
Satellite WellBound of San Mateo
San Mateo, California, 94403
Satellite WellBound of Santa Cruz
Santa Cruz, California, 95062
Satellite WellBound of Santa Rosa
Santa Rosa, California, 95407
Satellite Healthcare South Gate
South Gate, California, 90280
Satellite WellBound of Stockton
Stockton, California, 95219
Satellite Healthcare Tracy
Tracy, California, 95377
Satellite Healthcare Turlock West
Turlock, California, 95380
Satellite WellBound of Vallejo
Vallejo, California, 94590
About this study
Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD), represent alternatives to conventional in-center hemodialysis (HD) that for some patients may be better aligned with preferences regarding the integration of dialysis treatments into their lives. Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. While validated instruments (ICH CAHPS) are in use to assess patient experience with in-center HD, currently no validated instruments are available to measure patient-reported experience in home dialysis.
This Home Patient Experience Survey Validation Study is an in-house research study conducted in partnership with the University of Washington.
Read the detailed description
Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. No validated instruments are available to measure the patient-reported experience of care in-home dialysis patients. Such tools are needed as more patients are expected to choose home dialysis therapies in the future. This study aims to validate a home patient experience survey instrument.
This is a cross-sectional validation to determine the measurement properties of a new home dialysis patient experience survey instrument. Satellite Healthcare home dialysis patients will be approached by mail or by phone to complete the survey.
The aim of this study is to perform field testing for this newly developed instrument for the purposes of instrument validation and to determine survey instrument measurement properties. This will include the evaluation of any multi-item scales as well as an overall score.
- Conditions
- Home Dialysis, End Stage Renal Disease
- Being tested
- Survey using "Your Home Dialysis Care Experience" tool.
- Keywords
- ESRD, Dialysis, Patient Experience, Home Dialysis
- 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.
Survey using "Your Home Dialysis Care Experience" tool.Other
Validation of a new survey instrument to capture the experience of care by home dialysis patients.
| Study group | Role | What they receive |
|---|---|---|
| Mail Survey Participants | Approximately 1200 home patients will receive mail surveys. Of these, one thousand and twenty (1,020) patients will be asked to complete the survey once. One hundred and eighty (180) patients will be asked to complete the survey twice. Receives: Other: Survey using "Your Home Dialysis Care Experience" tool. | |
| Telephone Survey Participants | Three hundred (300) home patients will be surveyed by phone. Of those, one hundred and twenty will be asked to complete the survey once. One hundred and eighty patients will be asked to complete the phone surveys on two separate occasions. Receives: Other: Survey using "Your Home Dialysis Care Experience" tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the measurement model
The evaluation will encompass the survey burden, presence of a floor or ceiling effect for any item, test-retest reliability, development of multi-item subscales, internal consistency and reliability, center level reliability of the items and composites, and construct validity.
Measured: through survey completion, an average of 6 months
Secondary outcomes (1)
Survey response rate
Percent (%) of participants contacted who complete survey instrument
Measured: through survey completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start17 Jul 2020
- Primary completion2 Nov 2020
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home 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
- Other
- Time perspective
- Prospective
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435873
- Sponsor's protocol ID
- SP124 Home Experience
- Status last verified
- May 2021
- First submitted
- 12 Jun 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A de-identified data set of responses will be shared with the Kidney Research Institute at the University of Washington.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient-Reported Experience of Care for Home Dialysis (ASPIRED)
- ClinicalTrials.gov ID
- NCT04435873
- Acronym / sponsor ID
- SP124 Home Experience
- Conditions
- Home Dialysis, End Stage Renal Disease
- Keywords
- ESRD, Dialysis, Patient Experience, Home Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 17 Jun 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.
Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD), represent alternatives to conventional in-center hemodialysis (HD) that for some patients may be better aligned with preferences regarding the integration of dialysis treatments into their lives. Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. While validated instruments (ICH CAHPS) are in use to assess patient experience with in-center HD, currently no validated instruments are available to measure patient-reported experience in home dialysis.
This Home Patient Experience Survey Validation Study is an in-house research study conducted in partnership with the University of Washington.
Detailed description
Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. No validated instruments are available to measure the patient-reported experience of care in-home dialysis patients. Such tools are needed as more patients are expected to choose home dialysis therapies in the future. This study aims to validate a home patient experience survey instrument.
This is a cross-sectional validation to determine the measurement properties of a new home dialysis patient experience survey instrument. Satellite Healthcare home dialysis patients will be approached by mail or by phone to complete the survey.
The aim of this study is to perform field testing for this newly developed instrument for the purposes of instrument validation and to determine survey instrument measurement properties. This will include the evaluation of any multi-item scales as well as an overall score.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mail Survey Participants | – | Other: Survey using "Your Home Dialysis Care Experience" tool.Approximately 1200 home patients will receive mail surveys. Of these, one thousand and twenty (1,020) patients will be asked to complete the survey once. One hundred and eighty (180) patients will be asked to complete the survey twice. |
| Telephone Survey Participants | – | Other: Survey using "Your Home Dialysis Care Experience" tool.Three hundred (300) home patients will be surveyed by phone. Of those, one hundred and twenty will be asked to complete the survey once. One hundred and eighty patients will be asked to complete the phone surveys on two separate occasions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population is composed of those individuals receiving Home Dialysis care at Satellite Healthcare facilities,
Key inclusion criteria (1 listed)
- Patients receiving care for home dialysis at a facility that provides care for >= 3 patients at the time of cohort identification.
Key exclusion criteria (3 listed)
- Age < 18 years
- Patients receiving care for home dialysis at the facility for less than 3 months
- Institutionalized (senior nursing facility/multi-resident facility) or Hospice care patients
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 |
|---|---|---|
| Survey using "Your Home Dialysis Care Experience" tool.Validation of a new survey instrument to capture the experience of care by home dialysis patients. | Other | Mail Survey Participants, Telephone Survey Participants |
Primary outcome
Evaluation of the measurement model
Time frame: through survey completion, an average of 6 months
The evaluation will encompass the survey burden, presence of a floor or ceiling effect for any item, test-retest reliability, development of multi-item subscales, internal consistency and reliability, center level reliability of the items and composites, and construct validity.
1 secondary outcome
Survey response rate
Time frame: through survey completion, an average of 6 months
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 2 Dec 2021.
- Individual participant dataSharing planned: Undecided. A de-identified data set of responses will be shared with the Kidney Research Institute at the University of Washington.
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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.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Dialysis and End Stage Renal Disease, run by Satellite Healthcare at 32 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 1 inclusion and 3 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 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
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?
Evaluation of the measurement model (time frame: through survey completion, an average of 6 months). 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 2 Dec 2021.