Transitional Telehealth Home Care: REACH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 4
- 主要终点
- Parental Stress Score
研究概览
简要总结
The investigators want to determine if additional, increased contact with infants and families discharged to home after cardiac surgery improves infant and parent outcomes as compared to usual care.
详细描述
The investigators want to compare videoconferencing (SKYPE or FACTIME) and a monitoring system called Buddy Check is helpful. Buddy Check is a web-based tool using speech and internet technology to maintain contact with the health care team.
Infants are randomized to usual care or the intervention which uses automated daily phone calls and 2 virtual home visits each week. Weights, oxygen levels, and amount of food taken are obtained by the primary caregiver (parent) daily and sent via automated phone call, text message or email messages based on primary caregiver's desired.
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
- 2 Weeks 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery within 2.5 weeks of life,
- •Diagnosis of congenital heart disease,
- •Post menstrual age 37 weeks and older;
- •Minimum birth weight 2500 grams,
- •At least one parent speaks and reads English,
- •Anticipated discharge by 21 days of life
排除标准
- •Cardiomyopathy,
- •Diagnosis of Genetic syndrome
研究组 & 干预措施
Daily Messages, virtual home visits
Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level
Daily messages requesting weight, intake, pulse ox and pulse are automated
Virtual home visits occur twice weekly where the investigators see the infant and families.
干预措施: Daily Messages, Virtual Home Visits (Behavioral)
Usual Care
Infants will have usual care as defined by cardiology.
干预措施: Usual Care (Other)
结局指标
主要结局
Parental Stress Score
时间窗: Within 5 months of infant's life
Parental Stress will be measured through the use of the total score of Parental Stress Index collected at the completion of the study period for the infant and family, approximately 5 months of infant's life.
次要结局
- Parental Quality of life Score(Within 5 months of infant's life)
- Parental Social Isolation Score(Within 5 months of Infant's life.)
- Weight Gain at 5 months.(Within 5 months of life)
- Post Traumatic Stress Disorder Symptoms(Within 5 month's of Infant's Life)