BabySparks Developmental Application Pilot Study

Summary

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

Conditions

• Development, Child
• Adherence, Patient
• Congenital Heart Disease

Interventions

DEVICE

Babysparks Application

mHealth application, BabySparks©, will be implemented for infant and toddler developmental activities through 24 months of age. (Currently, BabySparks is only designed to work on the developmental milestones through 24 months of age, and therefore the use of the application will no longer be applicable to the patient after reaching a developmental age of 24 months. If the subject has not reached a developmental age of 24 months at the time he/she is chronologically 24 months, the subject/family will be able to continue to utilize the application for a maximum of 24 months from the time they began to use the application or until reaching a study endpoint of reaching 24 months developmentally or death, whichever the infant reaches first.)

OTHER

pre and post-test Redcap Survey

Prior to starting the use of the application, parents will be given a REDCap survey to complete to determine their current awareness and interventions being implemented with their child related to reaching developmental milestones. Data entered into application by the subject's caregivers will be stored by BabySparks.After completion of the use of the application (subject reaches a study endpoint), the caregivers will be asked to complete a REDCap survey asking them about their experience with the application.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City

  lead OTHER

Principal Investigators

• Lori Erickson, MSN · Children's Mercy Kansas City

Eligibility

Max Age

18 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-14

Primary Completion

2021-12-25

Completion

2023-05-17

Countries

• United States

Study Locations