CHU Besancon
Besançon, Besancon, 25000, France
NCT Number: NCT02902458
This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Besançon, Besancon, 25000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48 hours after implantation
Time frame: 2 weeks after implantation
Time frame: 2 months after implantation
Time frame: 4 months after implantation
Time frame: 6 months after implantation
Time frame: 12 months after implantation
Time frame: 48 hours after implantation
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Time frame: 2 weeks after implantation
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Time frame: 2 months after implantation
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Time frame: 4 months after implantation
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Time frame: 6 months after implantation
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Time frame: 12 months after implantation
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Time frame: 48 hours after implantation
Measure of state and trait anxiety
Time frame: 2 weeks after implantation
Measure of state and trait anxiety
Time frame: 2 months after implantation
Measure of state and trait anxiety
Time frame: 4 months after implantation
Measure of state and trait anxiety
Time frame: 6 months after implantation
Measure of state and trait anxiety
Time frame: 12 months after implantation
Measure of state and trait anxiety
Time frame: 48 hours after implantation
Evaluation of the quality of life in patients with heart failure
Time frame: 2 weeks after implantation
Evaluation of the quality of life in patients with heart failure
Time frame: 2 months after implantation
Evaluation of the quality of life in patients with heart failure
Time frame: 4 months after implantation
Evaluation of the quality of life in patients with heart failure
Time frame: 6 months after implantation
Evaluation of the quality of life in patients with heart failure
Time frame: 12 months after implantation
Evaluation of the quality of life in patients with heart failure
Centre Hospitalier Universitaire de Besancon
Other
Acronym: PEACE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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