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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
American Academy of Pediatrics
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01040988
First received: December 28, 2009
Last updated: December 29, 2009
Last verified: December 2009
History of Changes
  Purpose

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).


Condition
Depression
Anxiety
Post-Traumatic Stress Disorder

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD). [ Time Frame: One-time at enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • We intend to gather descriptive data on how patients in this age group view their devices. [ Time Frame: One-time at enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 254
Study Start Date: August 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pacemaker
Patients meeting entry criteria with a pacemaker in place.
ICD
Patients meeting entry criteria with an ICD in place.

  Eligibility

Ages Eligible for Study:   6 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040988

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
American Academy of Pediatrics
Investigators
Principal Investigator: Gregory Webster, MD Children's Hospital Boston
  More Information

Publications:

Responsible Party: Gregory Webster, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01040988     History of Changes
Other Study ID Numbers: X09-04-0195
Study First Received: December 28, 2009
Last Updated: December 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Pacemaker
Implantable cardioverter-defibrillator

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
 Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 19, 2013