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

Study Overview
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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).

Official Title
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The ICD/Device Expectations, Adaptations, and Successes (IDEAS) Study: the Relationship Between Implantable Cardioverter-defibrillators, Pacemakers and Psychiatric Symptoms in a Pediatric Population

Conditions
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Depression, Anxiety, Post-traumatic Stress Disorder

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker<br>Patients meeting entry criteria with a pacemaker in place. | |
| ICD<br>Patients meeting entry criteria with an ICD in place. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Implantable cardioverter-defibrillator