Mobile Monitoring of Children with Single Ventricle Congenital Heart Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-010225
Sponsor Protocol Number: 16-010225
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:
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available