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Completed

NCT Number: NCT01040988

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

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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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Post-traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.

    Time frame: One-time measure at enrollment

Secondary outcomes

  1. We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).

    Time frame: One-time at enrollment

  2. We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker.

    Time frame: One-time at enrollment

  3. We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers.

    Time frame: One-time at enrollement

  4. We intend to gather descriptive data on how patients in this age group view their devices.

    Time frame: One-time at enrollment

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • American Academy of Pediatrics

Registry information

Official study title

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

Acronym: IDEAS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 30, 2009
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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