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NCT03867903 · ClinicalTrials.gov registry record
BabySparks Developmental Application Pilot Study
A clinical trial, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- 66
- Enrollment target
NCT03867903: Completed study, sponsored by Children's Mercy Hospital Kansas City.
NCT03867903 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 66 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03867903 has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- 66 participants
- Enrollment target
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
Primary Outcome
satisfaction assessed through the end point survey
Interventions
- DEVICE Babysparks Application
- OTHER pre and post-test Redcap Survey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-03-14 |
| Est. Completion | 2023-05-17 |
What the finished NCT03867903 record still lists
NCT03867903 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Babysparks Application is the first listed.
NCT03867903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03867903 about?
NCT03867903 is a clinical study titled "BabySparks Developmental Application Pilot Study". 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. Se...
What is the current status of trial NCT03867903?
This trial is currently completed. The enrollment target is 66 participants. The study started on 2019-03-14. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT03867903?
The interventions under investigation include: Babysparks Application (DEVICE), pre and post-test Redcap Survey (OTHER).
Who is sponsoring clinical trial NCT03867903?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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