The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study (IDEAS)
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).
Post-Traumatic Stress Disorder
|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|
- 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 ]
- 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 ]
|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)|
Patients meeting entry criteria with a pacemaker in place.
Patients meeting entry criteria with an ICD in place.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040988
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Gregory Webster, MD||Children's Hospital Boston|