Clinical trial NCT02902458: Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study
Official title: Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Defibrillator User
Keywords: implantable cardioverter defibrillator
primary prevention
psychological follow-up
anxiety
depression
quality of life
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini International Neuropsychiatric Interview score
timeFrame: 48 hours after implantation
measure: Mini International Neuropsychiatric Interview score
timeFrame: 2 weeks after implantation
measure: Mini International Neuropsychiatric Interview score
timeFrame: 2 months after implantation
measure: Mini International Neuropsychiatric Interview score
timeFrame: 4 months after implantation
measure: Mini International Neuropsychiatric Interview score
timeFrame: 6 months after implantation
measure: Mini International Neuropsychiatric Interview score
timeFrame: 12 months after implantation
Secondary outcomes:
measure: Quality of life
timeFrame: 48 hours after implantation
measure: Quality of life
timeFrame: 2 weeks after implantation
measure: Quality of life
timeFrame: 2 months after implantation
measure: Quality of life
timeFrame: 4 months after implantation
measure: Quality of life
timeFrame: 6 months after implantation
measure: Quality of life
timeFrame: 12 months after implantation
measure: State-Trait Anxiety Inventory
timeFrame: 48 hours after implantation
measure: State-Trait Anxiety Inventory
timeFrame: 2 weeks after implantation
measure: State-Trait Anxiety Inventory
timeFrame: 2 months after implantation
measure: State-Trait Anxiety Inventory
timeFrame: 4 months after implantation
measure: State-Trait Anxiety Inventory
timeFrame: 6 months after implantation
measure: State-Trait Anxiety Inventory
timeFrame: 12 months after implantation
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: 48 hours after implantation
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: 2 weeks after implantation
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: 2 months after implantation
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: 4 months after implantation
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: 6 months after implantation
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: 12 months after implantation
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Alexandre Guignier, MD
role: PRINCIPAL_INVESTIGATOR
References: