The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study

Boston Children's Hospital166 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

166

Conditions

Depression Anxiety Post-traumatic Stress Disorder

Eligibility

Sex: ALLMin age: 6 YearsMax age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.

Time frame: One-time measure at enrollment

Secondary Outcomes

We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).

Time frame: One-time at enrollment

We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker.

Time frame: One-time at enrollment

We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers.

Time frame: One-time at enrollement

We intend to gather descriptive data on how patients in this age group view their devices.

Time frame: One-time at enrollment

The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes