Caregiver Monitoring of Children with Congenital Heart Disease

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

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