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

NCT00845234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-02-26

No results posted yet for this study

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

BEHAVIORAL

Intervention

Intervention 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.

Sponsors & Collaborators

  • Aurora Denver Cardiology Associates

    collaborator UNKNOWN

  • Medtronic

    collaborator INDUSTRY

  • East Carolina University

    lead OTHER

Principal Investigators

  • Samuel F Sears, Ph.D. · East Carolina University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845234 on ClinicalTrials.gov