Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Evaluating the Value of Telehealth for Care of Children With Medical Complexity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02849938
Recruitment Status : Completed
First Posted : July 29, 2016
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Information provided by (Responsible Party):
Advocate Health Care

Brief 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. 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)
  3. Compare the impact of the TytoCare telehealth device versus traditional telephone assessment on patient management and user satisfaction

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: TytoCare Device Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Value of Telehealth for Care of Children With Medical Complexity
Study Start Date : September 2016
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : March 20, 2017

Arm Intervention/treatment
No Intervention: Control Group
Usual care
Experimental: Telemedicine Group
TytoCare Device
Device: TytoCare Device
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Provider Survey [ Time Frame: 3 months ]
    Success of connection for telemedicine visits.

  2. Parent Survey [ Time Frame: 3 months ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria

  • Unable to comply with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02849938

Sponsors and Collaborators
Advocate Health Care
Layout table for investigator information
Principal Investigator: Patricia M Notario, MD Advocate Children's Hospital
  Study Documents (Full-Text)

Documents provided by Advocate Health Care:

Layout table for additonal information
Responsible Party: Advocate Health Care Identifier: NCT02849938    
Other Study ID Numbers: CCCMCTeleMed
First Posted: July 29, 2016    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.
Keywords provided by Advocate Health Care:
children with medical complexity
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases