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

University of North Carolina System

Status: Completed

Conditions: Arrhythmia

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00845234

00293-2008-0356-1

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Standard of Care Group

No Intervention group

Description:

Received the current standard of care as operationally defined by the investigators- Q\&A session + Video

Intervention Group

Experimental group

Description:

Intervention group- Patients will receive the brief educational CBT intervention + video and Q\&A session

Treatment:

Behavioral: Intervention