Implantable Cardioverter Defibrillator (ICD) Support Groups and Veterans

This study has been terminated.
(No funding, lost support staff, no data collected/processed)
Sponsor:
Information provided by (Responsible Party):
Heather Bloom, Emory University
ClinicalTrials.gov Identifier:
NCT00846417
First received: February 16, 2009
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition
Ventricular Fibrillation
Ventricular Tachycardia
Sudden Cardiac Death

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of ICD Support Groups in Veterans Receiving Internal Cardioverter Defibrillators

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • All veterans visiting the Atlanta Veterans Administration Medical Center will be screened and enrolled into 2 groups: ICD support group and Non ICD support group. [ Time Frame: Documented nine months after the time of enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • This study is observational. It entails questionnaires after enrollment regarding assessing the baseline quality of life in the Veterans on ICDs. [ Time Frame: Quality of life questionnaires at 3, 6 and 12 mos follow ups ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Patients with ICDs who attend the ICD Support Groups.
Control
Patients with ICDs who do not attend the ICD support groups.

Detailed 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients of primary care cardiology clinics at the Atlanta VAMC

Criteria

Inclusion Criteria:

  • Screen for enrollment into 2 groups - ICD support group and non ICD support group, consented, baseline set of QOL questionnaires

Exclusion Criteria:

  • Patients that experience varying degrees of psychological, social and physical adjustment both leading up to and following ICD.
  • Poor quality of life and depression.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846417

Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Heather L Bloom, MD, FACC Emory University IRB
  More Information

No publications provided

Responsible Party: Heather Bloom, Director, Cardiac Electrophysiology Services, Emory University
ClinicalTrials.gov Identifier: NCT00846417     History of Changes
Other Study ID Numbers: IRB00009530
Study First Received: February 16, 2009
Last Updated: September 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
myocardial infarction
heart failure
arrhythmia

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Death, Sudden, Cardiac
Death
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on July 22, 2014