Development, ChildNCT03867903
BabySparks Developmental Application Pilot Study
An observational study of Development, Child and Adherence, Patient, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Development, Child, Adherence, Patient, Congenital Heart Disease
- What is being tested?
- Babysparks Application and pre and post-test Redcap Survey
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 17 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
Official title: 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.
Read more
-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
Read the detailed 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 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
- Being tested
- Babysparks Application, pre and post-test Redcap Survey
- Medical subject headings
- Patient Compliance, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babysparks ApplicationDevice
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 SurveyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
satisfaction assessed through the end point survey
Measured: At end of 6 months Redcap Survey
Adoption
through uptake of application onto the phone
Measured: Date of Download of the application to the parent phone assessed 1 month
initial implementation
first date used after download
Measured: First date used after download onto parent phone assessed in 1 month
Utilization
Frequency of use after download
Measured: 6 months after study enrollment
Appropriateness
Parental Feedback from endpoint survey on appropriate developmental questions and interventions for their child
Measured: at end of study Redcap Survey ( 6 months after study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start14 Mar 2019
- Primary completion25 Dec 2021
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Development, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Erickson, Children's Mercy Hospital Kansas City
- Investigators
- Lori Erickson, MSN, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867903
- Sponsor's protocol ID
- Study00000385
- Status last verified
- May 2023
- First submitted
- 1 Mar 2019
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22218838McKechnie 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.
PubMed 28792608McWilliams 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.
PubMed 29567637
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BabySparks© App: A Pilot Study of mHealth Adherence to a Developmental Application for Infants After Neonatal Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03867903
- Acronym / sponsor ID
- Study00000385
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- • Families without access to a personal device for download (no devices will be provided)
- Wards of the state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Babysparks ApplicationmHealth 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.) | Device | – |
| pre and post-test Redcap SurveyPrior 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. | Other | – |
Primary outcome
Acceptability
Time frame: At end of 6 months Redcap Survey
satisfaction assessed through the end point survey
Adoption
Time frame: Date of Download of the application to the parent phone assessed 1 month
through uptake of application onto the phone
initial implementation
Time frame: First date used after download onto parent phone assessed in 1 month
first date used after download
Utilization
Time frame: 6 months after study enrollment
Frequency of use after download
Appropriateness
Time frame: at end of study Redcap Survey ( 6 months after study enrollment)
Parental Feedback from endpoint survey on appropriate developmental questions and interventions for their child
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 22218838Modi 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.
- Background: PubMed 28792608McKechnie 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.
- Background: PubMed 29567637McWilliams 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Erickson, MSN principal investigator
Children's Mercy Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development, Child and Adherence, Patient, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: At end of 6 months Redcap Survey). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.