Идёт набор NCT07707037

Removing Surrogates Uncertainty to Reduce Fear and Anxiety After Cardiac Events - Kids

Без фазы С лечением Cardiac Arrest Anxiety Depression Family Support

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Education Intervention.
Кому может быть актуально: Состояния в реестре: Cardiac Arrest, Anxiety Depression, Family Support. Базовые параметры: 0 Days — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Другое Education Intervention
Caregivers will receive education modules at multiple time points during their children's post cardiac arrest recovery trajectory

Первичные конечные точки

Retention Rate [Срок оценки: 3 months post enrollment]

Вторичные конечные точки (4)

Depression Screen as Measured by the Patient Health Questionnaire-4 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

Caregiver

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

Child

<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)