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

Primary Purpose

Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia focused on measuring behavioral intervention, implantable cardioverter defibrillator, psychosocial education, anxiety, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aurora Denver Cardiology Associates
  • Aurora Denver Cardiology Associates
  • East Carolina Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care Group

Intervention Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
February 17, 2009
Last Updated
February 25, 2013
Sponsor
East Carolina University
Collaborators
Aurora Denver Cardiology Associates, Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00845234
Brief Title
Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education
Official Title
Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University
Collaborators
Aurora Denver Cardiology Associates, Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
behavioral intervention, implantable cardioverter defibrillator, psychosocial education, anxiety, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Received the current standard of care as operationally defined by the investigators- Q&A session + Video
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group- Patients will receive the brief educational CBT intervention + video and Q&A session
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score on measure assessing construct of quality of life
Description
Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.
Time Frame
Up to 8 months after enrollment
Secondary Outcome Measure Information:
Title
Score on measure assessing depression
Description
Depression will be assessed via participant's self-reported scores on the depression subscale of the Hospital Anxiety and Depression Scale (HADS).
Time Frame
Up to 8 months after enrollment
Title
score on measure assessing construct of patient acceptance of device
Description
The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator.
Time Frame
up to 8 months after enrollment
Title
score on measure assessing anxiety
Description
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.
Time Frame
Up to 8 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel F Sears, Ph.D.
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
East Carolina Heart Institute
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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