Clinical Trials Directory

Trials / Completed

CompletedNCT00845234

Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education

Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
East Carolina University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. At present, there is a paucity of brief interventions for ICD patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. The present study examined the impact of a brief cognitive behavioral (CBT) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. It was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.

Conditions

Interventions

TypeNameDescription
BEHAVIORALInterventionIntervention consisted of a brief, educational CBT intervention and included the following domain areas: ICD knowledge and post-discharge care, understanding shock, stress management, family and relationships, device recall, and survivorship. The intervention was provided at baseline (0 weeks). Intervention was led by investigator and lasted 15 minutes in duration.

Timeline

Start date
2008-07-01
Primary completion
2011-01-01
Completion
2011-01-01
First posted
2009-02-18
Last updated
2013-02-26

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00845234. Inclusion in this directory is not an endorsement.