Clinical trial NCT01040988: The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Post-traumatic Stress Disorder
Keywords: Pacemaker
Implantable cardioverter-defibrillator
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
First posted: 2009-12-30
Enrollment: 166
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at participating center with pacemakers and ICDs who fit inclusion/exclusion criteria.

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).


Eligibility 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

Primary outcomes:
measure: To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.
timeFrame: One-time measure at enrollment
Secondary outcomes:
measure: We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).
timeFrame: One-time at enrollment
measure: We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker.
timeFrame: One-time at enrollment
measure: We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers.
timeFrame: One-time at enrollement
measure: We intend to gather descriptive data on how patients in this age group view their devices.
timeFrame: One-time at enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Gregory Webster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.