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

Completed

• Conditions: Depression; Anxiety; Post-traumatic Stress Disorder

• Registration Number: NCT01040988
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-12-28
• Study First Submitted QC: 2009-12-29
• Study First Posted: 2009-12-30
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.	One-time measure at enrollment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States