BabySparks Developmental Application Pilot Study

NCT03867903 | Completed

• 1 other identifier: Study00000385
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Acceptability

  satisfaction assessed through the end point survey

  At end of 6 months Redcap Survey

• Adoption

  through uptake of application onto the phone

  Date of Download of the application to the parent phone assessed 1 month

• initial implementation

  first date used after download

  First date used after download onto parent phone assessed in 1 month

• Utilization

  Frequency of use after download

  6 months after study enrollment

• Appropriateness

  Parental Feedback from endpoint survey on appropriate developmental questions and interventions for their child

  at end of study Redcap Survey ( 6 months after study enrollment)

Interventions

Babysparks Application DEVICE

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.)

pre and post-test Redcap Survey OTHER

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.

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with single ventricle cardiac disease are also known to have more complex hospitalizations and need for gastrostomy feeding tubes as compared to infants with bi-ventricular cardiac disease. The need for gastrostomy feeding is associated with a higher risk of cognitive, language, and motor delays in toddler age children with cardiac disease with Post-acute care interventions for physical and occupational therapy like "tummy time" are recommended for infants, but there is a lack of specific guidelines or recommendations in pediatric cardiac programs related to the use of mHealth interventions performed by parents after their discharge to home.

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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

• Modi AC, Pai AL, Hommel KA, Hood KK, Cortina S, Hilliard ME, Guilfoyle SM, Gray WN, Drotar D. Pediatric self-management: a framework for research, practice, and policy. Pediatrics. 2012 Feb;129(2):e473-85. doi: 10.1542/peds.2011-1635. Epub 2012 Jan 4.

  PMID: 22218838 BACKGROUND

• McKechnie AC, Rogstad J, Martin KM, Pridham KF. An exploration of co-parenting in the context of caring for a child prenatally diagnosed and born with a complex health condition. J Adv Nurs. 2018 Feb;74(2):350-363. doi: 10.1111/jan.13415. Epub 2017 Oct 4.

  PMID: 28792608 BACKGROUND

• McWilliams A, Reeves K, Shade L, Burton E, Tapp H, Courtlandt C, Gunter A, Dulin MF. Patient and Family Engagement in the Design of a Mobile Health Solution for Pediatric Asthma: Development and Feasibility Study. JMIR Mhealth Uhealth. 2018 Mar 22;6(3):e68. doi: 10.2196/mhealth.8849.

  PMID: 29567637 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Heart Defects, Congenital

Interventions

Lead

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Lori Erickson, MSN

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Remote Health Solutions

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 8, 2019
• Study Start: March 14, 2019
• Primary Completion: December 25, 2021
• Study Completion: May 17, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)