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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04177277
Other study ID # SIH119_mHealth
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 5, 2019
Est. completion date November 15, 2019

Study information

Verified date October 2020
Source Satellite Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 949
Est. completion date November 15, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Satellite Healthcare, Inc. San Jose California

Sponsors (1)

Lead Sponsor Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 One day
Primary 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 One day
Primary Common Concerns of patients regarding mHealth Survey question regarding potential concerns in usage of self mobile health resources One day
Primary Percentage of patients who currently use or would use mHealth services Number of patients who use MHealth compared to all patients surveyed One day
Primary Relationship of Age to mHealth usage statistical analysis One day
Primary Relationship of Gender to mHealth usage statistical analysis One day
Primary Relationship of Ethnicity to mHealth usage statistical analysis one day
Primary Relationship of Insurance Coverage to mHealth usage statistical analysis one day
Primary Relationship of Employment to mHealth usage statistical analysis one day
Secondary 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 One day
Secondary Percentage of staff who would be comfortable assisting patients to utilize mHealth Services Number of staff comfortable compared to all staff surveyed One day
Secondary Relationship of Staff age to smart device use and willingness to assist Analysis One day
Secondary Relationship of Staff position to smart device use and willingness to assist Analysis One day
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