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Dialysis mHealth Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04177277
Recruitment Status : Completed
First Posted : November 26, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Satellite Healthcare

Study Description
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Brief 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.

Condition or disease
ESRD

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
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Study Type : Observational
Actual Enrollment : 949 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Dialysis mHealth Survey (mHealth Access and Usage by Dialysis Patients and Staff)
Actual Study Start Date : July 5, 2019
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Common Concerns of patients regarding mHealth [ Time Frame: One day ]
    Survey question regarding potential concerns in usage of self mobile health resources

  4. 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

  5. Relationship of Age to mHealth usage [ Time Frame: One day ]
    statistical analysis

  6. Relationship of Gender to mHealth usage [ Time Frame: One day ]
    statistical analysis

  7. Relationship of Ethnicity to mHealth usage [ Time Frame: one day ]
    statistical analysis

  8. Relationship of Insurance Coverage to mHealth usage [ Time Frame: one day ]
    statistical analysis

  9. Relationship of Employment to mHealth usage [ Time Frame: one day ]
    statistical analysis


Secondary Outcome Measures :
  1. Percentage of staff who have access and ability to use smart devices and the internet [ Time Frame: One day ]
    Number of staff who have access compared to all patients surveyed

  2. Percentage of staff who would be comfortable assisting patients to utilize mHealth Services [ Time Frame: One day ]
    Number of staff comfortable compared to all staff surveyed

  3. Relationship of Staff age to smart device use and willingness to assist [ Time Frame: One day ]
    Analysis

  4. Relationship of Staff position to smart device use and willingness to assist [ Time Frame: One day ]
    Analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • Age < 18 years
  • Inability to participate because of cognitive impairment or active psychological condition
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177277


Locations
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United States, California
Satellite Healthcare, Inc.
San Jose, California, United States, 95128
Sponsors and Collaborators
Satellite Healthcare
Investigators
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Principal Investigator: Wael F Hussein, MBBS Satellite Healthcare, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Satellite Healthcare
ClinicalTrials.gov Identifier: NCT04177277    
Other Study ID Numbers: SIH119_mHealth
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Satellite Healthcare:
Dialysis
mHealth