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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arrhythmia

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Group<br>Received the current standard of care as operationally defined by the investigators- Q&A session + Video | |
| Experimental: Intervention Group<br>Intervention group- Patients will receive the brief educational CBT intervention + video and Q&A session | Behavioral: Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral intervention, implantable cardioverter defibrillator, psychosocial education, anxiety, depression