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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological follow-up | Experimental | 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. |
|
| Control | No Intervention | Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual interview with a qualified psychologist | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Guignier, MD | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besancon | Besançon | Besancon | 25000 | France |
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| 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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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