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

The University of Texas System (UT)

Status: Completed

Conditions: Chronic Diseases in Children

Treatments: Other: Comprehensive care (CC) program; Device: Enhanced telemedicine (ETM)

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 and oxygen saturation, auscultate the heart & lungs, and view the skin, throat, and tympanic membranes in the home.

Enrollment: 254 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)

---

254 participants in 2 patient groups

Comprehensive care (CC) program

Active Comparator group

Treatment:

Other: Comprehensive care (CC) program

Comprehensive care (CC) program augmented with enhanced telemedicine (ETM)

Experimental group

Treatment:

Device: Enhanced telemedicine (ETM)

Other: Comprehensive care (CC) program