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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01040988
First Posted: December 30, 2009
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Academy of Pediatrics
Information provided by (Responsible Party):
David DeMaso, Boston Children's Hospital
  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: Observational Model: Other
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:


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

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 ]

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 ]
  • 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 ]
  • 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 ]
  • We intend to gather descriptive data on how patients in this age group view their devices. [ Time Frame: One-time at enrollment ]

Enrollment: 166
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040988


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David DeMaso, Psychiatrist-in-Chief, Chairman, & The Leon Eisenberg Chair in Psychiatry, Boston Children's Hospital; George P. Gardner & Olga E. Monks Professor of Child Psychiatry & Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01040988     History of Changes
Other Study ID Numbers: X09-04-0195
First Submitted: December 28, 2009
First Posted: December 30, 2009
Last Update Posted: April 13, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders