Caregiver Monitoring of Children with Congenital Heart Disease
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 15-006998
Sponsor Protocol Number: 15-006998
About this study
The overall objective of this study is to determine whether non-medically trained caregivers can be educated to utilize home monitoring devices paired with our mobile application to collect and store patient-specific information regarding weight, pulse, and oxygen saturation levels for congenital heart disease patients.
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
- Caregivers up to 80 years
- Children hospitalized with any condition requiring daily body weight, pulse, and oxygen saturation levels via pulse-oximetery and arterial blood gases
- Children’s caregivers must be willing and able to:
- Read and utilize mobile technology to learn how to perform home monitoring tasks while their child is hospitalized
Exclusion Criteria:
- Caregivers who are unable to read English
- Children with any cause of non-congenital heart disease causes of hypoxemia such as carbon monoxide exposure
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