Clinical Trials Logo

Clinical Trial Summary

In this study, we will compare the quality of life in veterans having ICD who attend the ICD support groups to those who do not. We ask them to answer a set of quality of life questionnaires at baseline and then at 3,6,9 and 12 month visits. These questionnaires would be analyzed to assess if attending support groups made a difference. These results will be compared to a similar study done at Emory University on non veterans.


Clinical Trial Description

Sudden cardiac death (SCD) is a major clinical problem, responsible for 400,000 deaths annually in the US(2) Ventricular fibrillation/ventricular tachycardia (VF/VT) is the most common arrhythmia associated with SCD(3). ICD implantation is the only preventive treatment, and clinical trials have clearly established the efficacy of ICD placement for both primary and secondary prevention of SCD(4). Since 1996, ICD implantation has increased dramatically, from 20,000 per year, to 200,000 implanted per year in the US.

Patients are likely to experience varying degrees of psychological, social and physical adjustment both leading up to and following ICD implant. Poor quality of life and depression are common in patients with ICD(5). Anxiety is particularly common, with approximately 24 - 87% of ICD recipients experiencing increased symptoms of anxiety after implantation and diagnostic rates for clinically significant anxiety disorders ranging from 13-38%(6). The occurrence of ICD shocks is generally faulted for this psychological distress, but its causal influence is confounded by the presence of a life threatening medical condition. Depressive symptoms are reported in 24-33% of ICD patients(7). ICD shock related fears are universal and may be the most pervasive psychosocial adjustment challenge ICD patients face.

The literature suggests that ICD recipient QOL is not as high as that among recipients of more benign cardiac devices such as pacemakers. Concerns about ICD shocks and the negative effect of ICDs on patients' sense of control, social interactions, driving, sexuality, capacity to work, and ability to engage in leisure activities appear to adversely influence ICD recipients' perception of health and well being(8).

Support groups are a popular adjunctive treatment for ICD patients because they provide an efficient conduit for patient education spanning the biopsychosocial domains.(9) The active ingredients of support groups probably centre on the universality of many patient concerns and the sharing of information and strategies to deal effectively with these concerns. Dickerson et al found that ICD recipients and their support persons coped with traumatic experience of sudden cardiac death by using story telling in the support group to work through the anxiety and place the event into a manageable explanation(10). Clinical nurse specialist (CNS) - facilitated support group are beneficial if offered, especially if they contact the ICD recipients early during hospitalization and making them aware of this resource(11). ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00846417
Study type Observational
Source Emory University
Contact
Status Terminated
Phase N/A
Start date July 2008
Completion date June 2010

See also
  Status Clinical Trial Phase
Recruiting NCT03453645 - Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Completed NCT05791032 - Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study N/A
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Completed NCT04011631 - Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. N/A
Recruiting NCT03536052 - Ablation at Virtual-hEart pRedicted Targets for VT N/A
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Enrolling by invitation NCT02962076 - Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia Early Phase 1
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Completed NCT01791543 - Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia N/A
Terminated NCT02891863 - Low Energy Therapy to Convert Ventricular Tachycardias Phase 0
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT01294267 - Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation N/A
Terminated NCT00383799 - Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT04642963 - Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia N/A
Recruiting NCT05377216 - Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation Early Phase 1
Not yet recruiting NCT04990089 - VIVO European Observational Registry
Completed NCT04065893 - Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Recruiting NCT03631303 - Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
Recruiting NCT03611465 - Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts N/A