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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Depression Anxiety Post-traumatic Stress Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pacemaker

Patients meeting entry criteria with a pacemaker in place.

No interventions assigned to this group

ICD

Patients meeting entry criteria with an ICD in place.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR