Mobile Monitoring of Children with Single Ventricle Congenital Heart Disease

Overview

About this study

The primary aim of this study is to create a streamlined home monitoring process with modern technologies that are both usable and efficient.  The overall objective of this study is to determine whether or not this application helps improve the efficiency of medical care teams while providing care to interstage participants through the use of usability metrics.  Secondarily, this study introduces a prioritization system that estimates the current risk profile of individual patients to help medical care teams better prioritize their weekly workflows.  Although this mobile application is not a mobile medical device according to the definition of the FDA guidance documents (not requiring IDE), documenting the feasibility of this mobile application to be used within the context of standardized home monitoring programs will inform the use of this technology into clinical practice. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

 Inclusion Criteria:

           Children with congenital heart disease along with their caregivers

  • Children ages 0-5 years with shunt-dependent single ventricular systems during the pre- and the post-Glenn palliation (which includes the interstage period)
  • Caregivers up to 80 years

Children’s caregivers must be willing and able to:

  • Read and utilize mobile technology to learn how to perform home monitoring tasks

Exclusion Criteria: 

  • Caregivers who are unable to read English
  • Medical care team staff unwilling to use the enterprise mobile application

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Nelson, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20317857

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