BabySparks Developmental Application Pilot Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/10/2019 |
| Start Date: | February 28, 2019 |
| End Date: | September 30, 2019 |
BabySparks© App: A Pilot Study of mHealth Adherence to a Developmental Application for Infants After Neonatal Cardiac Surgery
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
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
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
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
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
We found this trial at
1
site
Click here to add this to my saved trials
