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
NCT number | NCT03867903 |
Other study ID # | Study00000385 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 14, 2019 |
Est. completion date | May 17, 2023 |
Verified date | May 2023 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 66 |
Est. completion date | May 17, 2023 |
Est. primary completion date | December 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Months |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - • 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Kansas City | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability | satisfaction assessed through the end point survey | At end of 6 months Redcap Survey | |
Primary | Adoption | through uptake of application onto the phone | Date of Download of the application to the parent phone assessed 1 month | |
Primary | initial implementation | first date used after download | First date used after download onto parent phone assessed in 1 month | |
Primary | Utilization | Frequency of use after download | 6 months after study enrollment | |
Primary | 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) |
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