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

Boston Children's Hospital

Status: Completed

Conditions: Post-traumatic Stress Disorder; Depression; Anxiety

Study type: Observational

Funder types: Other

Identifiers

NCT01040988

X09-04-0195

Details and patient eligibility

About

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).

Enrollment: 166 patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

166 participants in 2 patient groups

Pacemaker

Description:

Patients meeting entry criteria with a pacemaker in place.

ICD

Description:

Patients meeting entry criteria with an ICD in place.