Chronic Diseases in ChildrenNCT05408143
An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity
A study testing Comprehensive care (CC) program and Enhanced telemedicine (ETM) in people with Chronic Diseases in Children, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Diseases in Children
- What is being tested?
- Comprehensive care (CC) program and Enhanced telemedicine (ETM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Major heart disease
- Mitochondrial disorders
- Active cancer
- Do-Not-Resuscitate (DNR) order
- Patients receiving compassionate care
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Chronic Diseases in Children
- Being tested
- Comprehensive care (CC) program, Enhanced telemedicine (ETM)
- Keywords
- Comprehensive Care, Telemedicine enhanced with TytoCare devices., Telemedicine, children with medical complexity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive care (CC) programOther
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.
Enhanced telemedicine (ETM)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive care (CC) program | Active comparator | Not described Receives: Other: Comprehensive care (CC) program |
| Comprehensive care (CC) program augmented with enhanced telemedicine (ETM) | Experimental | Not described Receives: Other: Comprehensive care (CC) program; Device: Enhanced telemedicine (ETM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Care Provided in a Medical Setting
Measured: end of study(about 24 months)
Total Number of Episodes of Serious Illnesses (Causing Death, Pediatric ICU Admission, and Hospital Stay > 7d).
Measured: end of study(about 24 months)
Secondary outcomes (8)
Cost Effectiveness of ETM
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
Measured: end of study(about 24 months)
Number of Hospital Admissions Due to All-Cause Infections
Measured: end of study(about 24 months)
Average Numbers of Clinic Visits
Measured: end of study(about 24 months)
Average Total Number of Emergency Department Visits
Measured: end of study(about 24 months)
Average Number of Hospital Days
Measured: end of study(about 24 months)
Average Number of Pediatric Intensive Care Unit (PICU) Days
Measured: end of study(about 24 months)
Total Number of Deaths
Measured: end of study(about 24 months)
Parent Ratings of Care Assessed Using the Consumer Assessment of Healthcare Providers and Systems Survey
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.
Measured: end of study(about 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start12 Jul 2022
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Diseases in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The Systems and Policy Research Network
- Responsible party
- Principal investigator, Ricardo A. Mosquera, The University of Texas Health Science Center, Houston
- Investigators
- Ricardo A Mosquera, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408143
- Sponsor's protocol ID
- HSC-MS-21-0829
- Other IDs
- 5 UA6MC31101-05-00
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2022
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity Receiving Comprehensive Care: a Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05408143
- Acronym / sponsor ID
- HSC-MS-21-0829
- Conditions
- Chronic Diseases in Children
- Keywords
- Comprehensive Care, Telemedicine enhanced with TytoCare devices., Telemedicine, children with medical complexity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Systems and Policy Research Network
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Posted 14 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive care (CC) program | Active comparator | Other: Comprehensive care (CC) program |
| Comprehensive care (CC) program augmented with enhanced telemedicine (ETM) | Experimental | Other: Comprehensive care (CC) program, Device: Enhanced telemedicine (ETM) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Major heart disease
- Mitochondrial disorders
- Active cancer
- Do-Not-Resuscitate (DNR) order
- Patients receiving compassionate care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive care (CC) programTo 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. | Other | Comprehensive care (CC) program, Comprehensive care (CC) program augmented with enhanced telemedicine (ETM) |
| 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. | Device | Comprehensive care (CC) program augmented with enhanced telemedicine (ETM) |
Primary outcome
Number of Days Care Provided in a Medical Setting
Time frame: 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)
8 secondary outcomes
Cost Effectiveness of ETM
Time frame: end of study(about 24 months)
Number of Hospital Admissions Due to All-Cause Infections
Time frame: end of study(about 24 months)
Average Numbers of Clinic Visits
Time frame: end of study(about 24 months)
Average Total Number of Emergency Department Visits
Time frame: end of study(about 24 months)
Average Number of Hospital Days
Time frame: end of study(about 24 months)
Average Number of Pediatric Intensive Care Unit (PICU) Days
Time frame: end of study(about 24 months)
Total Number of Deaths
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A Mosquera, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive care (CC) program and Enhanced telemedicine (ETM) in people with Chronic Diseases in Children, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Care Provided in a Medical Setting (time frame: end of study(about 24 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.