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

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845234
• Other study ID #: 00293-2008-0356-1
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: February 25, 2013
• Start date: July 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2013
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years old

• literate

• newly implanted with an implantable cardioverter defibrillator (ICD)

Exclusion Criteria:

• documented neurological sequelae associated with CVA or dementia

• documented cognitive impairment

• reported illiteracy

• previously implanted ICD

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia

Intervention

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.

Locations

Country	Name	City	State
United States	Aurora Denver Cardiology Associates	Aurora	Colorado
United States	East Carolina Heart Institute	Greenville	North Carolina
United States	Aurora Denver Cardiology Associates	Lone Tree	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
East Carolina University	Aurora Denver Cardiology Associates, Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on measure assessing construct of quality of life	Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.	Up to 8 months after enrollment	No
Secondary	Score on measure assessing depression	Depression will be assessed via participant's self-reported scores on the depression subscale of the Hospital Anxiety and Depression Scale (HADS).	Up to 8 months after enrollment	No
Secondary	score on measure assessing construct of patient acceptance of device	The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator.	up to 8 months after enrollment	No
Secondary	score on measure assessing anxiety	The Hospital Anxiety and Depression Scale is comprised of two subscales- anxiety and depression. It is a self-report measure that generates a score on the patient's current level of anxiety.	Up to 8 months after enrollment	No