The ICD/Device Expectations, Adaptations, and Successes (IDEAS) Study: the Relationship Between Implantable Cardioverter-defibrillators, Pacemakers and Psychiatric Symptoms in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.
研究概览
简要总结
The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. In the case of patients with ICDs, these devices are programmed to deliver a strong electrical shocks. In adults, multiple studies have suggested that patients at risk of receiving shocks from their device have an increased prevalence of anxiety and depression. Very few studies have looked at this question in children. We propose to evaluate a cohort of patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing each group for the presence of depressive and anxiety disorders, including post-traumatic stress disorder (PTSD).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 through 20 at the time of enrollment for patients.
- •Age ≥18 for caregiver
- •Functioning pacemaker or ICD (explanted or inoperative devices do not qualify)
- •Informed consent of parent or guardian as well as assent of study participant
排除标准
- •Lack of English language fluency in patient and caregiver
- •Hospitalization within 4 weeks of visit
- •First implantation of ICD or pacemaker within 6 months of study enrollment
结局指标
主要结局
To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.
时间窗: One-time measure at enrollment
次要结局
- We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers.(One-time at enrollement)
- We intend to gather descriptive data on how patients in this age group view their devices.(One-time at enrollment)
- We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).(One-time at enrollment)
- We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker.(One-time at enrollment)
研究者
David DeMaso
Psychiatrist-in-Chief, Chairman, & The Leon Eisenberg Chair in Psychiatry, Boston Children's Hospital; George P. Gardner & Olga E. Monks Professor of Child Psychiatry & Professor of Pediatrics, Harvard Medical School
Boston Children's Hospital