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An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Chronic Diseases in Children

Treatments

Device: enhanced telemedicine (ETM)
Other: CC

Study type

Interventional

Funder types

Other

Identifiers

NCT05408143
5 UA6MC31101-05-00 (Other Grant/Funding Number)
HSC-MS-21-0829

Details and patient eligibility

About

The purpose of this study is to assess if the benefits for children with medical complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be further improved by enhanced telemedicine program (ETM) provided during clinic hours using mobile devices to measure temperature& oxygen saturation, auscultate the heart & lungs, and view the skin, throat, & tympanic membranes in the home.

Enrollment

300 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Greater than or equal to 2 hospitalizations or greater than or equal to 1 ICU admission in the year before joining the comprehensive care program
  • Greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director

Exclusion criteria

  • Major heart disease
  • Mitochondrial disorders
  • Active cancer
  • Do-Not-Resuscitate (DNR) order
  • Patients receiving compassionate care

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

usual CC (with conventional telemedicine)
Active Comparator group
Treatment:
Other: CC
comprehensive care (CC) augmented with enhanced telemedicine (ETM)
Experimental group
Treatment:
Device: enhanced telemedicine (ETM)
Other: CC

Trial contacts and locations

1

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Central trial contact

Ricardo A Mosquera, MD; Diana J Martinez Castillo

Data sourced from clinicaltrials.gov

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