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

April 12, 2017 updated by: David DeMaso, Boston Children's Hospital

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at participating center with pacemakers and ICDs who fit inclusion/exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pacemaker
Patients meeting entry criteria with a pacemaker in place.
ICD
Patients meeting entry criteria with an ICD in place.

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: One-time measure at enrollment
One-time measure at enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).
Time Frame: One-time at enrollment
One-time at enrollment
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
One-time at enrollment
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
One-time at enrollement
We intend to gather descriptive data on how patients in this age group view their devices.
Time Frame: One-time at enrollment
One-time at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

American Academy of Pediatrics

Investigators

  • Principal Investigator: Gregory Webster, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

December 29, 2009

First Posted (Estimate)

December 30, 2009

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X09-04-0195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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