Cerebral PalsyNCT02849938
Evaluating the Value of Telehealth for Care of Children With Medical Complexity
A study testing TytoCare Device in people with Cerebral Palsy, run by Wake Forest University Health Sciences.
Trial summary
The specific aims of the study are to: 1. Assess the feasibility of a TytoCare telehealth device with remote audio/video connection for evaluation of children with medical complexity in the home environment. 2. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- TytoCare Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 20 Mar 2017
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient aged 1 month to 18 years
- Patient currently enrolled in CCCMC program at ACH-OL
- Parental permission/consent
- English-speaking (at least one parent)
- Internet connected home wi-fi
Who cannot join
- Unable to comply with study requirements
About this study
The specific aims of the study are to:
- Assess the feasibility of a TytoCare telehealth device with remote audio/video connection for evaluation of children with medical complexity in the home environment.
- Evaluate the usability of a TytoCare telehealth device in transmitting real time images (otoscope, oropharyngeal exam, camera), temperature, and sound (stethoscope for heart and breath sounds)
- Compare the impact of the TytoCare telehealth device versus traditional telephone assessment on patient management and user satisfaction
Read the detailed description
Eligible children of interested parent(s) will be randomly assigned to either the control group (standard care) or the intervention group (Tyto device). Randomization will be performed using an online randomization program to generate group assignments for the 25 subjects. Subjects will be stratified by whether they have a tracheostomy or not and be assigned 1.5:1 to achieve 15 children in the device group and 10 children in the control group. Informed consent will be obtained for children in each group.
Children/families in the control group will continue to get usual care through the CCCMC program, and will be able to access their providers via telephone for urgent care needs and scheduled follow up. For evaluation purposes, data collection will include the monthly encounter tracking that is done routinely as part of the CCCMC program, and research surveys completed by both parents and HCPs. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey electronic survey with each telephone encounter where the HCP would have liked to use the device.
For those assigned to the device group, parents will be instructed to contact their CCCMC HCP as usual, see bullet points above, when health concerns arise and their HCP will decide if she would like a telehealth visit. Telehealth/video visits may also be scheduled in advance as a matter of routine follow-up care. In the event that an exam is deemed necessary by the HCP, the parent or caregiver will be directed to connect via the remote exam device. The provider will conduct a 2-way live interactive audio/video visit with the patient. The parent or caregiver will use the remote exam device to provide temperature, lung sounds, heart sounds, oropharyngeal exam, skin exam and/or ear exam as clinically indicated. Direction for necessary treatment, referral to an ED, clinic or inpatient care will be at the discretion of the CCCMC provider. For evaluation purposes, in addition to the monthly encounter tracking that is done as part of the CCCMC program, both parents and HCPs will complete surveys. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey via a Qualtrics link with each telehealth encounter.
Additional data collected will include subject demographics, and encounter data that is routinely collected as a part of the CCCMC program. Images of patient encounters will be transmitted in real time via the telemedicine device encrypted software. Provider Survey data will be gathered via Qualtrics. Tyto will retain / store data obtained from device group encounters in a de-identified way for development purposes only.
- Conditions
- Cerebral Palsy
- Being tested
- TytoCare Device
- Keywords
- children with medical complexity, Telemedicine, Tracheostomy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TytoCare DeviceDevice
Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Usual care |
| Telemedicine Group | Experimental | TytoCare Device Receives: Device: TytoCare Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of In-person Health Care Encounters
Hospital day length of stay reported as the total number of hospital days in the group.
Measured: 3 months
Secondary outcomes (2)
Provider Survey
Success of connection for telemedicine visits.
Measured: 3 months
Parent Survey
Overall satisfaction with device, comfort with Device, satisfaction with clinician interactions and development of plans of care; Questions asked using 4 point Likert scale (4 = Very Satisfied , 1=Very Dissatisfied). Higher score more satisfaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion31 Jan 2017
- Study completion20 Mar 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia M Notario, MD, Principal investigator, Advocate Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849938
- Sponsor's protocol ID
- CCCMCTeleMed
- Status last verified
- Apr 2017
- First submitted
- 27 Jul 2016
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.
Publications
Notario PM, Gentile E, Amidon M, Angst D, Lefaiver C, Webster K. Home-Based Telemedicine for Children with Medical Complexity. Telemed J E Health. 2019 Nov;25(11):1123-1132. doi: 10.1089/tmj.2018.0186. Epub 2019 Jan 30.
PubMed 30628860
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Value of Telehealth for Care of Children With Medical Complexity
- ClinicalTrials.gov ID
- NCT02849938
- Acronym / sponsor ID
- CCCMCTeleMed
- Conditions
- Cerebral Palsy
- Keywords
- children with medical complexity, Telemedicine, Tracheostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of the study are to:
- Assess the feasibility of a TytoCare telehealth device with remote audio/video connection for evaluation of children with medical complexity in the home environment.
- Evaluate the usability of a TytoCare telehealth device in transmitting real time images (otoscope, oropharyngeal exam, camera), temperature, and sound (stethoscope for heart and breath sounds)
- Compare the impact of the TytoCare telehealth device versus traditional telephone assessment on patient management and user satisfaction
Detailed description
Eligible children of interested parent(s) will be randomly assigned to either the control group (standard care) or the intervention group (Tyto device). Randomization will be performed using an online randomization program to generate group assignments for the 25 subjects. Subjects will be stratified by whether they have a tracheostomy or not and be assigned 1.5:1 to achieve 15 children in the device group and 10 children in the control group. Informed consent will be obtained for children in each group.
Children/families in the control group will continue to get usual care through the CCCMC program, and will be able to access their providers via telephone for urgent care needs and scheduled follow up. For evaluation purposes, data collection will include the monthly encounter tracking that is done routinely as part of the CCCMC program, and research surveys completed by both parents and HCPs. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey electronic survey with each telephone encounter where the HCP would have liked to use the device.
For those assigned to the device group, parents will be instructed to contact their CCCMC HCP as usual, see bullet points above, when health concerns arise and their HCP will decide if she would like a telehealth visit. Telehealth/video visits may also be scheduled in advance as a matter of routine follow-up care. In the event that an exam is deemed necessary by the HCP, the parent or caregiver will be directed to connect via the remote exam device. The provider will conduct a 2-way live interactive audio/video visit with the patient. The parent or caregiver will use the remote exam device to provide temperature, lung sounds, heart sounds, oropharyngeal exam, skin exam and/or ear exam as clinically indicated. Direction for necessary treatment, referral to an ED, clinic or inpatient care will be at the discretion of the CCCMC provider. For evaluation purposes, in addition to the monthly encounter tracking that is done as part of the CCCMC program, both parents and HCPs will complete surveys. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey via a Qualtrics link with each telehealth encounter.
Additional data collected will include subject demographics, and encounter data that is routinely collected as a part of the CCCMC program. Images of patient encounters will be transmitted in real time via the telemedicine device encrypted software. Provider Survey data will be gathered via Qualtrics. Tyto will retain / store data obtained from device group encounters in a de-identified way for development purposes only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Usual care |
| Telemedicine Group | Experimental | Device: TytoCare DeviceTytoCare Device |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient aged 1 month to 18 years
- Patient currently enrolled in CCCMC program at ACH-OL
- Parental permission/consent
- English-speaking (at least one parent)
- Internet connected home wi-fi
Key exclusion criteria (1 listed)
- Unable to comply with study requirements
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 |
|---|---|---|
| TytoCare DeviceTyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment. | Device | Telemedicine Group |
Primary outcome
Frequency of In-person Health Care Encounters
Time frame: 3 months
Hospital day length of stay reported as the total number of hospital days in the group.
2 secondary outcomes
Provider Survey
Time frame: 3 months
Parent Survey
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30628860Notario PM, Gentile E, Amidon M, Angst D, Lefaiver C, Webster K. Home-Based Telemedicine for Children with Medical Complexity. Telemed J E Health. 2019 Nov;25(11):1123-1132. doi: 10.1089/tmj.2018.0186. Epub 2019 Jan 30.
- Individual participant dataSharing planned: No. Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.
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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.
Patricia M Notario, MD principal investigator
Advocate Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TytoCare Device in people with Cerebral Palsy, run by Wake Forest University Health Sciences.
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 5 inclusion and 1 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 5 Feb 2019). 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?
Frequency of In-person Health Care Encounters (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849938, which also lists 1 linked publication.
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 8 Oct 2024.