BabySparks Developmental Application Pilot Study

Completed

Conditions studied: Development, Child, Adherence, Patient, Congenital Heart Disease

In brief

A single site, cross-sectional, pilot study of a mHealth application. Primary Objective This purpose of this pilot study is to evaluate mHealth adherence to a developmental application, Babysparks©, by parents of infants with complex congenital cardiac disease and single ventricle heart disease. Secondary Objective(s) -To determine the demographic and infant characteristics that correlate with mHealth adherence. -The rate of developmental progress of milestones while using the application will also be compared between infants with single ventricle cardiac disease and bi-ventricular cardiac disease. Research Intervention(s)/ Investigational Agent(s) Babysparks© developmental application is the main intervention with evaluation on feasibility of the mHealth application in a pediatric cardiology population. Study participants will be parents of infants with single ventricle and bi-ventricular complex congenital heart disease who underwent cardiac surgery in the first six weeks of life and are currently less than 18 months of age. Study Population There are approximately 150 new patients a year who have undergone cardiac surgery, with an additional 150 who are 18 months of age or less. Sample Size A maximum of 400 families/year Study Duration for Individual Participants Study participants will be monitored for a minimum of 6 months with the use of the BabySparks© App; to a maximum of 24 months of use of the app or when the child reaches a developmental age of 24 months, whichever occurs first. Study Specific Abbreviations/ Definitions mHealth : mobile health CHD: Congenital heart disease

Key facts

Study ID

NCT03867903

Run by

Children's Mercy Hospital Kansas City

People needed

66

Starts

2019-03-14

Expected to finish

2023-05-17

Last updated by the study team

2023-05-18

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study participants will be infants (and their parents) who have undergone cardiac surgery at Children's Mercy Kansas City in the first six weeks of life and are currently less than 18 months of age at the time of being approached for participation in this study.

You may not qualify if…

• • Families without access to a personal device for download (no devices will be provided)
• Children who are deceased prior to the family being approached for study participation
• Neonates that are considered non-viable, or have the potential to be non-viable
• Spanish-only speaking families
• Exclude special populations:
• Wards of the state

Where it is running

• Children's Mercy Kansas City — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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