ESRDNCT04988568
Experience of Patients Starting Hemodialysis
An observational study of ESRD, run by Satellite Healthcare at 17 sites in United States.
Trial summary
Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- What is being tested?
- None. This is a qualitative interview study.
- How many people
- 20 participants
- Where
- 17 sitesUnited States
- Study dates
- 2 Aug 2021to 31 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All incident in-center hemodialysis patients meeting eligibility criteria at Satellite Healthcare, Inc., at IRB approved dialysis centers.
Who may be able to join
- Patients receiving in-center hemodialysis care at Satellite Healthcare at the start of the study period.
- Patients who started with in-center hemodialysis as a first renal replacement therapy.
- Patients receiving dialysis for ≤ 90 days.
Who cannot join
- Age < 18 years.
- Unable to understand or communicate in English.
- Inability to participate because of cognitive impairment or active psychological condition.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Satellite Healthcare Los Gatos
Los Gatos, California, 95032
Satellite Healthcare Menlo Park
Menlo Park, California, 94025
Satellite Heathcare Milpitas
Milpitas, California, 95035
Satellite Dialysis Morgan Hill
Morgan Hill, California, 95037
Satellite Health Morgan Hill
Morgan Hill, California, 95037
Satellite Healthcare Mountain View
Mountain View, California, 94040
Satellite Healthcare Oakland
Oakland, California, 94609
Satellite Healthcare San Carlos
San Carlos, California, 94070
Satellite Healthcare East San Jose
San Jose, California, 95116
Satellite Health Blossom Valley
San Jose, California, 95118
Satellite Health San Teresa
San Jose, California, 95119
Satellite Healthcare SIlver Creek
San Jose, California, 95121
Satellite Health South San Jose
San Jose, California, 95123
Satellite Healthcare Evergreen
San Jose, California, 95148
Satellite Dialysis San Leandro
San Leandro, California, 94577
Satellite Healthcare West San Leandro
San Leandro, California, 94577
Satellite Dialysis San Mateo
San Mateo, California, 94403
About this study
Official title: Experience of Patients Starting Hemodialysis: A Qualitative Study
Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives.
Read the detailed description
Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives, understand what made patient experiences better, and what could further improve their experiences when patients first start dialysis. The investigators will enroll patients within 90 days of starting dialysis, and conduct semi-structured recorded interviews with patients. All patients will provide informed consent. The interviews will be transcribed verbatim.
- The transcripts will be reviewed line by line by qualitative researchers to identify concepts and themes, and will be developed into a coding schema.
- The preliminary themes will be discussed among the investigators to facilitate consensus.
- Conditions
- ESRD
- Being tested
- None. This is a qualitative interview study.
- 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 patients will be interviewed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences of patients starting dialysis.
Collect information from interviews to understand the experiences of patients starting dialysis.
Measured: One time interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start2 Aug 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 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
- 20 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, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988568
- Sponsor's protocol ID
- SIH130
- Status last verified
- May 2022
- First submitted
- 26 Jul 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: 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Patients Starting Hemodialysis: A Qualitative Study
- ClinicalTrials.gov ID
- NCT04988568
- Acronym / sponsor ID
- SIH130
- Conditions
- ESRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 3 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 starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives.
Detailed description
Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives, understand what made patient experiences better, and what could further improve their experiences when patients first start dialysis. The investigators will enroll patients within 90 days of starting dialysis, and conduct semi-structured recorded interviews with patients. All patients will provide informed consent. The interviews will be transcribed verbatim.
- The transcripts will be reviewed line by line by qualitative researchers to identify concepts and themes, and will be developed into a coding schema.
- The preliminary themes will be discussed among the investigators to facilitate consensus.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All incident in-center hemodialysis patients meeting eligibility criteria at Satellite Healthcare, Inc., at IRB approved dialysis centers.
Key inclusion criteria (3 listed)
- Patients receiving in-center hemodialysis care at Satellite Healthcare at the start of the study period.
- Patients who started with in-center hemodialysis as a first renal replacement therapy.
- Patients receiving dialysis for ≤ 90 days.
Key exclusion criteria (3 listed)
- Age < 18 years.
- Unable to understand or communicate in English.
- Inability to participate because of cognitive impairment or active psychological condition.
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 patients will be interviewed. | Other | – |
Primary outcome
Experiences of patients starting dialysis.
Time frame: One time interview.
Collect information from interviews to understand the experiences of patients starting dialysis.
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.
- Individual participant dataSharing planned: No. No individual person data will be available to anyone other than Satellite Healthcare Research employees.
Related trials for ESRD
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
17 sites 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 17 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 3 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 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 17 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?
Experiences of patients starting dialysis. (time frame: One time interview.). 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 20 May 2022.