An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Levels Stress for Caregivers of 1-Ventricle Cardiac Defect Infants
研究概览
简要总结
This study will conduct an initial clinical evaluation of this support program to examine its impact on reducing caregiver stress, increasing confidence in daily feeding, and improving weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).
详细描述
Caregivers of infants with CHD are at high-risk of anxiety and distress due to the complex daily caregiving demands. Previous research has demonstrated decreased parental stress and more optimal infant developmental outcomes with a psychosocial intervention delivered to caregivers of infants with CHD prior to hospital discharge as well as reduced healthcare use in caregivers who received medical video-consultations during the interstage surgical palliation period. This study will implement a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs. The program is delivered via video chat over the Internet and caregivers will complete questionnaires about general family information, stress, and feeding their infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver's infant is less than 45 days of age at time of study enrollment.
- •Caregiver of infant with high-risk, shunt dependent physiology (one or two-ventricle circulation) having just received neonatal surgery for CHD.
- •English is a primary language for caregiver of infant.
排除标准
- •Caregiver's infant is greater than 45 days of age at time of study enrollment.
- •Not a caregiver of infant with high-risk, shunt dependent physiology having just received neonatal surgery for CHD.
- •English is not a primary language for caregiver of infant.
结局指标
主要结局
Change in Levels Stress for Caregivers of 1-Ventricle Cardiac Defect Infants
时间窗: Baseline, Week 18
Stress levels will be measured by the Pediatric Inventory for Parents (PIP) which is a 42-item measure that assesses disease-related parenting stress and asks caregivers to indicate the frequency at which disease-related parenting stressor occurs, and the difficulty-level of each stressor.
Change in Levels Stress for Caregivers of 2-Ventricle Cardiac Defect Infants
时间窗: Baseline, Week 18
Stress levels will be measured by the Pediatric Inventory for Parents (PIP) which is a 42-item measure that assesses disease-related parenting stress and asks caregivers to indicate the frequency at which disease-related parenting stressor occurs, and the difficulty-level of each stressor.
次要结局
- Change in Levels of Caregiver Confidence in Feeding Management for 2-Ventricle Cardiac Defect Infants(Baseline, Week 18)
- Change in Infant Weight for 1-Ventricle Cardiac Defect Infants(Baseline, Week 18)
- Change in Infant Weight for 2-Ventricle Cardiac Defect Infants(Baseline, Week 18)
- Number of Unplanned Hospital Admissions(Week 18)
- Change in Levels of Caregiver Confidence in Feeding Management for 1-Ventricle Cardiac Defect Infants(Baseline, Week 18)
研究者
Brandon Aylward
Associate Professor
Emory University