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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01040988

Acronym

IDEAS

Enrollment

166

Registered

2009-12-30

Start date

2009-08-31

Completion date

2010-10-31

Last updated

2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Post-traumatic Stress Disorder

Keywords

Pacemaker, Implantable cardioverter-defibrillator

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Years to 20 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results