Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study

Study Overview
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Brief Summary
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This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.

Detailed Description
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The implantation of an ICD in primary prevention is known to increase the rates of anxiety and depression, which can reach up to 45% and 35% respectively in this patient population. Several studies have reported that psychological accompaniment for these patients can alleviate the symptoms of anxiety and/or depression. Therefore, we aim to investigate the utility of psychological follow-up for a period of 1 year after first implantation of an ICD for primary prevention.

Official Title
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Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study

Conditions
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Implantable Defibrillator User

Intervention / Treatment
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* Other: Individual interview with a qualified psychologist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (aged 18 years or over) indication for implantation of an ICD for primary prophylaxis written informed consent provided patients with social security coverage Exclusion Criteria: patients under legal tutorship or guardianship patients with no social security coverage patients still within the exclusion period after participation in another clinical trial, as indicated by the national registry of clinical trial volunteers patients unable to complete the questionnaires (language barriers, mentally deficient, illiteracy or dementia) patients awaiting heart transplant patients who refuse to provide written informed consent

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological follow-up<br>Patients undergoing implantation of an ICD for primary prevention will have an individual interview with a qualified psychologist in addition to standard medical follow-up. | Other: Individual interview with a qualified psychologist<br>* Individual, recorded interview with a qualified psychologist to discuss any and all subjects related to the ICD implantation, or any other topics deemed relevant by the patient.<br>|
| No Intervention: Control<br>Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini International Neuropsychiatric Interview score |  | 48 hours after implantation | 
| Mini International Neuropsychiatric Interview score |  | 2 weeks after implantation | 
| Mini International Neuropsychiatric Interview score |  | 2 months after implantation | 
| Mini International Neuropsychiatric Interview score |  | 4 months after implantation | 
| Mini International Neuropsychiatric Interview score |  | 6 months after implantation | 
| Mini International Neuropsychiatric Interview score |  | 12 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire | 48 hours after implantation | 
| Quality of life | Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire | 2 weeks after implantation | 
| Quality of life | Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire | 2 months after implantation | 
| Quality of life | Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire | 4 months after implantation | 
| Quality of life | Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire | 6 months after implantation | 
| Quality of life | Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire | 12 months after implantation | 
| State-Trait Anxiety Inventory | Measure of state and trait anxiety | 48 hours after implantation | 
| State-Trait Anxiety Inventory | Measure of state and trait anxiety | 2 weeks after implantation | 
| State-Trait Anxiety Inventory | Measure of state and trait anxiety | 2 months after implantation | 
| State-Trait Anxiety Inventory | Measure of state and trait anxiety | 4 months after implantation | 
| State-Trait Anxiety Inventory | Measure of state and trait anxiety | 6 months after implantation | 
| State-Trait Anxiety Inventory | Measure of state and trait anxiety | 12 months after implantation | 
| Minnesota Living with Heart Failure questionnaire | Evaluation of the quality of life in patients with heart failure | 48 hours after implantation | 
| Minnesota Living with Heart Failure questionnaire | Evaluation of the quality of life in patients with heart failure | 2 weeks after implantation | 
| Minnesota Living with Heart Failure questionnaire | Evaluation of the quality of life in patients with heart failure | 2 months after implantation | 
| Minnesota Living with Heart Failure questionnaire | Evaluation of the quality of life in patients with heart failure | 4 months after implantation | 
| Minnesota Living with Heart Failure questionnaire | Evaluation of the quality of life in patients with heart failure | 6 months after implantation | 
| Minnesota Living with Heart Failure questionnaire | Evaluation of the quality of life in patients with heart failure | 12 months after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable cardioverter defibrillator, primary prevention, psychological follow-up, anxiety, depression, quality of life