Implantable Cardioverter Defibrillator (ICD) Support Groups and Veterans

NCT00846417 | Terminated DMC

• 1 other identifier: IRB00009530
• Study Type: observational
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventricular Fibrillation; Ventricular Tachycardia; Sudden Cardiac Death

Keywords

myocardial infarction; heart failure; arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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.

  Documented nine months after the time of enrollment.

Secondary Outcomes (1)

• This study is observational. It entails questionnaires after enrollment regarding assessing the baseline quality of life in the Veterans on ICDs.

  Quality of life questionnaires at 3, 6 and 12 mos follow ups

Study Arms (2)

Case

Patients with ICDs who attend the ICD Support Groups.

Control

Patients with ICDs who do not attend the ICD support groups.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of primary care cardiology clinics at the Atlanta VAMC

You may qualify if:

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

You may not qualify if:

• Patients that experience varying degrees of psychological, social and physical adjustment both leading up to and following ICD.
• Poor quality of life and depression.

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular; Death, Sudden, Cardiac; Myocardial Infarction; Heart Failure; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Heart Arrest; Death, Sudden; Death; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Heather L Bloom, MD, FACC

  Emory University IRB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Electrophysiology Services

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 12, 2013

Record last verified: 2013-09