ESRDNCT04177277
Dialysis mHealth Survey
An observational study of ESRD, run by Satellite Healthcare at 1 site in United States.
Trial summary
This is a survey of dialysis patients and staff to determine both the readiness of ESRD patients to use mHealth as well as the Readiness of the dialysis center staff (healthcare technicians, nurses and administrative staff) to utilize mHealth in order to assist patients who may have barriers to do so for themselves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- How many people
- 949 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 15 Nov 2019
- 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 Dialysis patients and staff at participating centers (both in-center and home-based) who volunteer to participate in the study by completing the one-time survey. Centers selected for participation were in California, Tennessee, and Texas.
Who may be able to join
- • On dialysis (either in-center or home) at a participating Satellite Healthcare center within the recruitment period
- Any Satellite Dialysis staff member with patient interaction.
Who cannot join
- Age < 18 years
- Inability to participate because of cognitive impairment or active psychological condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Satellite Healthcare, Inc.
San Jose, California, 95128
About this study
Official title: Dialysis mHealth Survey (mHealth Access and Usage by Dialysis Patients and Staff)
This is a survey of dialysis patients and staff to determine both the readiness of ESRD patients to use mHealth as well as the Readiness of the dialysis center staff (healthcare technicians, nurses and administrative staff) to utilize mHealth in order to assist patients who may have barriers to do so for themselves.
Read the detailed description
This is a cross-sectional observational study. Approximately 700 ESRD patients currently on dialysis will be recruited from Satellite In-Center (Hemodialysis) and WellBound (Home Dialysis) Centers in the US. These will include centers in Texas, Tennessee, and California. In addition, about 100 dialysis staff will be recruited to complete a staff mHealth Questionnaire.
Patients and staff will be asked questions that conform to Khatun's conceptual model.
- Technological readiness:
- Availability of the devices and internet
- Ability to use the devices
- Human resource readiness:
- Socio-demographics
- Awareness of mHealth services
- Motivational readiness
- Concerns (cost/privacy/ other)
- Attitudes/intentions: Current use or potential for use.
- Conditions
- ESRD
- Keywords
- Dialysis, mHealth
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who have access to and ability to use smart devices and the internet
Number of Patients who have access compared to all patients surveyed
Measured: One day
Percentage of patients aware of mHealth Services
Number of patients who have awareness of websites, apps or other sites used for self mobile health compared to al patients surveyed
Measured: One day
Common Concerns of patients regarding mHealth
Survey question regarding potential concerns in usage of self mobile health resources
Measured: One day
Percentage of patients who currently use or would use mHealth services
Number of patients who use MHealth compared to all patients surveyed
Measured: One day
Relationship of Age to mHealth usage
statistical analysis
Measured: One day
Relationship of Gender to mHealth usage
statistical analysis
Measured: One day
Relationship of Ethnicity to mHealth usage
statistical analysis
Measured: one day
Relationship of Insurance Coverage to mHealth usage
statistical analysis
Measured: one day
Relationship of Employment to mHealth usage
statistical analysis
Measured: one day
Secondary outcomes (4)
Percentage of staff who have access and ability to use smart devices and the internet
Number of staff who have access compared to all patients surveyed
Measured: One day
Percentage of staff who would be comfortable assisting patients to utilize mHealth Services
Number of staff comfortable compared to all staff surveyed
Measured: One day
Relationship of Staff age to smart device use and willingness to assist
Analysis
Measured: One day
Relationship of Staff position to smart device use and willingness to assist
Analysis
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start5 Jul 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 949 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
- NCT04177277
- Sponsor's protocol ID
- SIH119_mHealth
- Status last verified
- Oct 2020
- First submitted
- 20 Nov 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hussein WF, Bennett PN, Pace S, Chen S, Legg V, Atwal J, Sun S, Schiller B. The Mobile Health Readiness of People Receiving In-Center Hemodialysis and Home Dialysis. Clin J Am Soc Nephrol. 2020 Dec 31;16(1):98-106. doi: 10.2215/CJN.11690720. Epub 2020 Dec 22.
PubMed 33355235
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis mHealth Survey (mHealth Access and Usage by Dialysis Patients and Staff)
- ClinicalTrials.gov ID
- NCT04177277
- Acronym / sponsor ID
- SIH119_mHealth
- Conditions
- ESRD
- Keywords
- Dialysis, mHealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 949 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 26 Nov 2019 (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.
This is a survey of dialysis patients and staff to determine both the readiness of ESRD patients to use mHealth as well as the Readiness of the dialysis center staff (healthcare technicians, nurses and administrative staff) to utilize mHealth in order to assist patients who may have barriers to do so for themselves.
Detailed description
This is a cross-sectional observational study. Approximately 700 ESRD patients currently on dialysis will be recruited from Satellite In-Center (Hemodialysis) and WellBound (Home Dialysis) Centers in the US. These will include centers in Texas, Tennessee, and California. In addition, about 100 dialysis staff will be recruited to complete a staff mHealth Questionnaire.
Patients and staff will be asked questions that conform to Khatun's conceptual model.
- Technological readiness:
- Availability of the devices and internet
- Ability to use the devices
- Human resource readiness:
- Socio-demographics
- Awareness of mHealth services
- Motivational readiness
- Concerns (cost/privacy/ other)
- Attitudes/intentions: Current use or potential for use.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Dialysis patients and staff at participating centers (both in-center and home-based) who volunteer to participate in the study by completing the one-time survey. Centers selected for participation were in California, Tennessee, and Texas.
Key inclusion criteria (2 listed)
- • On dialysis (either in-center or home) at a participating Satellite Healthcare center within the recruitment period
Key exclusion criteria (2 listed)
- Age < 18 years
- 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.
Primary outcome
Percentage of patients who have access to and ability to use smart devices and the internet
Time frame: One day
Number of Patients who have access compared to all patients surveyed
Percentage of patients aware of mHealth Services
Time frame: One day
Number of patients who have awareness of websites, apps or other sites used for self mobile health compared to al patients surveyed
Common Concerns of patients regarding mHealth
Time frame: One day
Survey question regarding potential concerns in usage of self mobile health resources
Percentage of patients who currently use or would use mHealth services
Time frame: One day
Number of patients who use MHealth compared to all patients surveyed
Relationship of Age to mHealth usage
Time frame: One day
statistical analysis
Relationship of Gender to mHealth usage
Time frame: One day
statistical analysis
Relationship of Ethnicity to mHealth usage
Time frame: one day
statistical analysis
Relationship of Insurance Coverage to mHealth usage
Time frame: one day
statistical analysis
Relationship of Employment to mHealth usage
Time frame: one day
statistical analysis
4 secondary outcomes
Percentage of staff who have access and ability to use smart devices and the internet
Time frame: One day
Percentage of staff who would be comfortable assisting patients to utilize mHealth Services
Time frame: One day
Relationship of Staff age to smart device use and willingness to assist
Time frame: One day
Relationship of Staff position to smart device use and willingness to assist
Time frame: One day
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 22 Oct 2020.
- Derived from this study: PubMed 33355235Hussein WF, Bennett PN, Pace S, Chen S, Legg V, Atwal J, Sun S, Schiller B. The Mobile Health Readiness of People Receiving In-Center Hemodialysis and Home Dialysis. Clin J Am Soc Nephrol. 2020 Dec 31;16(1):98-106. doi: 10.2215/CJN.11690720. Epub 2020 Dec 22.
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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.
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 2 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 22 Oct 2020. 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?
Percentage of patients who have access to and ability to use smart devices and the internet (time frame: One day). The study lists 9 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 NCT04177277, which also lists 1 linked publication.
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 Oct 2020.