NCT02849938

Brief Summary

The specific aims of the study are to:

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

October 8, 2024

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

July 27, 2016

Results QC Date

April 10, 2018

Last Update Submit

October 2, 2024

Conditions

Cerebral Palsy

Keywords

children with medical complexityTelemedicineTracheostomy

Outcome Measures

Primary Outcomes (1)

  • Frequency of In-person Health Care Encounters

    Hospital day length of stay reported as the total number of hospital days in the group.

    3 months

Secondary Outcomes (2)

  • Provider Survey

    3 months

  • Parent Survey

    3 months

Study Arms (2)

Control Group

NO INTERVENTION

Usual care

Telemedicine Group

EXPERIMENTAL

TytoCare Device

Device: TytoCare Device

Interventions

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.

Telemedicine Group

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30628860DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Patricia M Notario, MD
Organization
Billings Clinic
pnotario@billingsclinic.org
406-238-2143

Study Officials

  • Patricia M Notario, MD

    Advocate Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

July 29, 2016

Study Start

September 1, 2016

Primary Completion

January 31, 2017

Study Completion

March 20, 2017

Last Updated

October 8, 2024

Results First Posted

February 5, 2019

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.