NCT04177277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
949

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

November 20, 2019

Last Update Submit

October 20, 2020

Conditions

ESRD

Keywords

DialysismHealth

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • Common Concerns of patients regarding mHealth

    Survey question regarding potential concerns in usage of self mobile health resources

    One day

  • Percentage of patients who currently use or would use mHealth services

    Number of patients who use MHealth compared to all patients surveyed

    One day

  • Relationship of Age to mHealth usage

    statistical analysis

    One day

  • Relationship of Gender to mHealth usage

    statistical analysis

    One day

  • Relationship of Ethnicity to mHealth usage

    statistical analysis

    one day

  • Relationship of Insurance Coverage to mHealth usage

    statistical analysis

    one day

  • Relationship of Employment to mHealth usage

    statistical analysis

    one day

Secondary Outcomes (4)

  • Percentage of staff who have access and ability to use smart devices and the internet

    One day

  • Percentage of staff who would be comfortable assisting patients to utilize mHealth Services

    One day

  • Relationship of Staff age to smart device use and willingness to assist

    One day

  • Relationship of Staff position to smart device use and willingness to assist

    One day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 18 years
  • Inability to participate because of cognitive impairment or active psychological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Satellite Healthcare, Inc.

San Jose, California, 95128, United States

Location

Related Publications (1)

  • 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.

    PMID: 33355235DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wael F Hussein, MBBS

    Satellite Healthcare, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 26, 2019

Study Start

July 5, 2019

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

US(1)