Clinical trial NCT04177277: Dialysis mHealth Survey
Official title: Dialysis mHealth Survey (mHealth Access and Usage by Dialysis Patients and Staff)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ESRD
Keywords: Dialysis
mHealth
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 949
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients who have access to and ability to use smart devices and the internet
timeFrame: One day
measure: Percentage of patients aware of mHealth Services
timeFrame: One day
measure: Common Concerns of patients regarding mHealth
timeFrame: One day
measure: Percentage of patients who currently use or would use mHealth services
timeFrame: One day
measure: Relationship of Age to mHealth usage
timeFrame: One day
measure: Relationship of Gender to mHealth usage
timeFrame: One day
measure: Relationship of Ethnicity to mHealth usage
timeFrame: one day
measure: Relationship of Insurance Coverage to mHealth usage
timeFrame: one day
measure: Relationship of Employment to mHealth usage
timeFrame: one day
Secondary outcomes:
measure: Percentage of staff who have access and ability to use smart devices and the internet
timeFrame: One day
measure: Percentage of staff who would be comfortable assisting patients to utilize mHealth Services
timeFrame: One day
measure: Relationship of Staff age to smart device use and willingness to assist
timeFrame: One day
measure: Relationship of Staff position to smart device use and willingness to assist
timeFrame: One day
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Satellite Healthcare, Inc.
state: California
Study officials:
affiliation: Satellite Healthcare, Inc.
name: Wael F Hussein, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.