Removing Surrogates Uncertainty to Reduce Fear and Anxiety After Cardiac Events - Kids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
This pilot randomized controlled trial (RCT) will test the feasibility and acceptability of the informational intervention program, Heartsight, to reduce caregivers' uncertainty experienced throughout their child's illness trajectory after cardiac arrest. The investigator aims to enroll up to 30 caregivers of pediatric cardiac arrest patients to (Aim 1a) pilot recruitment and randomization (2:1) procedures, and (Aim 1b) estimate retention rate at 3 months and assess engagement and utilization metrics for frequency of access and time spent on each module of the informational packages. The investigator also aims to evaluate the association of the intervention with efficacy outcomes in an exploratory manner in preparation for a larger trial, including (Aim2a) a preliminary estimate of the association of intervention with the surrogate's uncertainty levels at 3 months post-discharge, and (Aim 2b) a preliminary estimate of the association of intervention with the surrogate's anxiety, depression, and post-traumatic stress symptoms at 3 months post-discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver of a child <17.5 years of age who had at least a 2 minute cardiac arrest, is expected to be discharged within 30 days, and to survive at least 3 months post-discharge from hospital.
- •English speaking
- •<17.5 years of age
- •Have had a cardiac arrest lasting more than 2 minutes within the past 7 days and have not yet been discharged from pediatric intensive care unit (PICU) or cardiac intensive care unit (CICU)
排除标准
- •1) Parent or legal guardian is not the child's caregiver
结局指标
主要结局
Retention Rate
时间窗: 3 months post enrollment
Proportion of enrolled caregivers who complete the study requirements
次要结局
- Depression Screen as Measured by the Patient Health Questionnaire-4(Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.)
- Anxiety Screen as Measured by the Patient Health Questionnaire-4(Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.)
- Presence and Severity of Post Traumatic Stress Disorder Symptoms as Measured by the Posttraumatic Stress Disorder Checklist (PCL-5)(Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.)
- Uncertainty regarding a child's medical diagnosis, treatment, or health condition as measured by Parents' Perception of Uncertainty Scale (PPUS)(Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.)