BabySparks Developmental Application Pilot Study
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adherence, Patient
- Congenital Heart Disease
- Development, Child
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 app...
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
Tracking Information
- NCT #
- NCT03867903
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lori Erickson, MSN Children's Mercy Kansas City