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

NCT00845234 | Completed DMC

• 1 other identifier: 00293-2008-0356-1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

Brief 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

Arrhythmia

Keywords

behavioral intervention; implantable cardioverter defibrillator; psychosocial education; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Score on measure assessing depression

  Up to 8 months after enrollment

• score on measure assessing construct of patient acceptance of device

  up to 8 months after enrollment

• score on measure assessing anxiety

  Up to 8 months after enrollment

Study Arms (2)

Standard of Care Group

NO INTERVENTION

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

Intervention Group

EXPERIMENTAL

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

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• literate
• newly implanted with an implantable cardioverter defibrillator (ICD)

You may not qualify if:

• documented neurological sequelae associated with CVA or dementia
• documented cognitive impairment
• reported illiteracy
• previously implanted ICD

Sponsors & Collaborators

• East Carolina University: lead
• Aurora Denver Cardiology Associates: collaborator
• Medtronic: collaborator

Study Sites (3)

Aurora Denver Cardiology Associates

Aurora, Colorado, 80012, United States

Location

Aurora Denver Cardiology Associates

Lone Tree, Colorado, 80124, United States

Location

East Carolina Heart Institute

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Anxiety Disorders; Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Samuel F Sears, Ph.D.

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: July 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

US (3)