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

July 23, 2026 updated by: Ricardo A. Mosquera, The University of Texas Health Science Center, Houston

An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity Receiving Comprehensive Care: a Single-Center Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comprehensive care (CC) program
Other: Comprehensive care (CC) program
To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Experimental: Comprehensive care (CC) program augmented with enhanced telemedicine (ETM)
Other: Comprehensive care (CC) program
To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
Device: Enhanced telemedicine (ETM)
An enhanced telemedicine program (using the HIPAA-compliant, mobile TytoCare exam kit device) will be added to CC to allow providers to remotely visualize the skin, throat, & ears, auscultate the heart & lungs, and measure illnesses during clinic hours and chronic illnesses during the detailed patient evaluation to be conducted at least every 6 months by "virtual patient rounds" in the home. These visits will involve the parent(s), the primary care physician (PCP), and if needed, any of 10 specialists, particularly pulmonology, gastroenterology, neurology, and physical medicine and rehabilitation. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual patient rounds per week to proactively identify medical problems, suboptimal adherence to treatment, dosing errors, or other problems and intervene before CMC develop a serious illness or require avoidable clinic visits, Emergency Department visits, or hospitalizations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Days Care Provided in a Medical Setting
Time Frame: end of study(about 24 months)
end of study(about 24 months)
Total Number of Episodes of Serious Illnesses (Causing Death, Pediatric ICU Admission, and Hospital Stay > 7d).
Time Frame: end of study(about 24 months)
end of study(about 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost Effectiveness of ETM
Time Frame: end of study(about 24 months)
this is defined strictly as a reduction in serious illnesses without an increase in health system costs, a decrease in health system costs without an increase in serious illnesses, or a reduction in both
end of study(about 24 months)
Number of Hospital Admissions Due to All-Cause Infections
Time Frame: end of study(about 24 months)
end of study(about 24 months)
Average Numbers of Clinic Visits
Time Frame: end of study(about 24 months)
end of study(about 24 months)
Average Total Number of Emergency Department Visits
Time Frame: end of study(about 24 months)
end of study(about 24 months)
Average Number of Hospital Days
Time Frame: end of study(about 24 months)
end of study(about 24 months)
Average Number of Pediatric Intensive Care Unit (PICU) Days
Time Frame: end of study(about 24 months)
end of study(about 24 months)
Total Number of Deaths
Time Frame: end of study(about 24 months)
end of study(about 24 months)
Parent Ratings of Care Assessed Using the Consumer Assessment of Healthcare Providers and Systems Survey
Time Frame: end of study(about 24 months)
This survey consists of 5 questions. The first 4 are scored from 1(never)-4(always) for a maximum score of 16 , a higher number indicating better care. The fifth question is scored form 0-10 a higher number indicating a better provider.
end of study(about 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

The Systems and Policy Research Network

Investigators

  • Principal Investigator: Ricardo A Mosquera, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

August 26, 2024

Study Completion (Actual)

August 26, 2024

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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