BabySparks Developmental Application Pilot Study

Congenital Heart Disease Clinical Trial

Official title: BabySparks© App: A Pilot Study of mHealth Adherence to a Developmental Application for Infants After Neonatal Cardiac Surgery

Status Completed

Clinical Trial 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

Clinical Trial Description

Study design. A single site, cross-sectional, pilot study, with a pre/post-test design will be used to evaluate the mHealth adherence and the parental feedback after using this application. Additional feasibility measures of the application will be evaluated through the engagement and use of the application, use of the mHealth data back to the research team, and frequency of the parents implementing app-suggested activities, and the infants' ability to complete these developmental activities during use of the application.

Theoretical Framework. Pediatric self-management theoretical framework follows infants to adolescents on a dynamic continuum with frequent modifiable and non-modifiable factors, processes, and behaviors that may affect adherence and outcomes. The factors may come from individual non-modifiable congenital heart disease, family factors, community support, and the health care system where the infant has their care. The interplay between parental stress and adherence to developmental interventions are highlighted in this theoretical framework, and allows for an underpinning framework for this study. Previous work with parental caregiving and motivation has included a theoretical model of the attachment-parenting theory which also supports this study to encourage interactive behaviors and developmental interventions.

Research Procedures: The mHealth application will be downloaded by parents onto up to 5 devices of their choosing with a primary email address as the linking account.

The parents will be sent a REDCap survey prior to starting the use of the application to determine their current awareness and interventions being implemented with their child related to reaching developmental milestones, and a second survey will be sent to the family at the end of study period to get their feedback on the mHealth application.

Data to be collected from the Electronic medical record (Stored in REDcap form), none of these are going to be stored in an identifiable manner: Cardiac diagnosis, Prenatal diagnosis, Cardiac surgery, Major genetic diagnosis, Major non-cardiac diagnosis, Age in days of cardiac surgery, Length of neonatal hospitalization (Days), Used the app prior to discharge, Age in days when parent started using the application, Total number of days in the hospital the first year of life, Total number of ICU days in the first year of life, Primary parent age, Primary parent gender, Primary parent education level, Number of other siblings, Route of feeds at discharge, Distance from the hospital at home ;

Related Conditions & MeSH terms

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

• NCT number: NCT03867903
• Study type: Observational
• Source: Children's Mercy Hospital Kansas City
• Status: Completed
• Start date: March 14, 2019
• Completion date: May 17, 2023