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

Depression Clinical Trial

— IDEAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040988
• Other study ID #: X09-04-0195
• Status: Completed
• Phase: N/A
• First received: December 28, 2009
• Last updated: April 12, 2017
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	American Academy of Pediatrics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).		One-time at enrollment
Secondary	We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker.		One-time at enrollment
Secondary	We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers.		One-time at enrollement
Secondary	We intend to gather descriptive data on how patients in this age group view their devices.		One-time at enrollment