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

Not Applicable

Completed

• Conditions: Implantable Defibrillator User
• Interventions: Other: Individual interview with a qualified psychologist

• Registration Number: NCT02902458
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-12
• Last Update Submitted: 2016-09-12
• Study First Posted: 2016-09-15
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychological follow-up	Individual interview with a qualified psychologist	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.

Primary Outcome Measures

Name	Time	Method
Mini International Neuropsychiatric Interview score	12 months after implantation

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months after implantation	Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
State-Trait Anxiety Inventory	12 months after implantation	Measure of state and trait anxiety
Minnesota Living with Heart Failure questionnaire	12 months after implantation	Evaluation of the quality of life in patients with heart failure

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besancon, France