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

NCT01040988 | Completed

• 1 other identifier: X09-04-0195
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Anxiety; Post-traumatic Stress Disorder

Keywords

Pacemaker; Implantable cardioverter-defibrillator

Outcome Measures

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.

  One-time measure at enrollment

Secondary Outcomes (4)

• 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

Study Arms (2)

Pacemaker

Patients meeting entry criteria with a pacemaker in place.

ICD

Patients meeting entry criteria with an ICD in place.

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• American Academy of Pediatrics: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• DeMaso DR, Lauretti A, Spieth L, van der Feen JR, Jay KS, Gauvreau K, Walsh EP, Berul CI. Psychosocial factors and quality of life in children and adolescents with implantable cardioverter-defibrillators. Am J Cardiol. 2004 Mar 1;93(5):582-7. doi: 10.1016/j.amjcard.2003.11.022.

  PMID: 14996583 BACKGROUND

• Webster G, Panek KA, Labella M, Taylor GA, Gauvreau K, Cecchin F, Martuscello M, Walsh EP, Berul CI, DeMaso DR. Psychiatric functioning and quality of life in young patients with cardiac rhythm devices. Pediatrics. 2014 Apr;133(4):e964-72. doi: 10.1542/peds.2013-1394. Epub 2014 Mar 24.

  PMID: 24664095 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Gregory Webster, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: December 28, 2009
• First Posted: December 30, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

US (1)