跳至主要内容
临床试验/NCT03867903
NCT03867903已完成不适用

BabySparks© App: A Pilot Study of mHealth Adherence to a Developmental Application for Infants After Neonatal Cardiac Surgery

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Adoption

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
— 至 18 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •• 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

结局指标

主要结局

Adoption

时间窗: Date of Download of the application to the parent phone assessed 1 month

through uptake of application onto the phone

Utilization

时间窗: 6 months after study enrollment

Frequency of use after download

Acceptability

时间窗: At end of 6 months Redcap Survey

satisfaction assessed through the end point survey

initial implementation

时间窗: First date used after download onto parent phone assessed in 1 month

first date used after download

Appropriateness

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Erickson

Director Remote Health Solutions

Children's Mercy Hospital Kansas City

研究点 (1)

Loading locations...

相似试验