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NCT02902458 Clinical Trial

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

Implantable Defibrillator User Clinical Trial

— PEACE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02902458
Other study ID # P/2014/217
Secondary ID
Status Completed
Phase N/A
First received September 1, 2016
Last updated September 12, 2016
Start date September 2014
Est. completion date August 2016

Study information
Verified date September 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Individual interview with a qualified psychologist
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.

Locations
Country Name City State
France CHU Besancon Besancon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mini International Neuropsychiatric Interview score 48 hours after implantation No
Primary Mini International Neuropsychiatric Interview score 2 weeks after implantation No
Primary Mini International Neuropsychiatric Interview score 2 months after implantation No
Primary Mini International Neuropsychiatric Interview score 4 months after implantation No
Primary Mini International Neuropsychiatric Interview score 6 months after implantation No
Primary Mini International Neuropsychiatric Interview score 12 months after implantation No
Secondary Quality of life Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire 48 hours after implantation No
Secondary Quality of life Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire 2 weeks after implantation No
Secondary Quality of life Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire 2 months after implantation No
Secondary Quality of life Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire 4 months after implantation No
Secondary Quality of life Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire 6 months after implantation No
Secondary Quality of life Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire 12 months after implantation No
Secondary State-Trait Anxiety Inventory Measure of state and trait anxiety 48 hours after implantation No
Secondary State-Trait Anxiety Inventory Measure of state and trait anxiety 2 weeks after implantation No
Secondary State-Trait Anxiety Inventory Measure of state and trait anxiety 2 months after implantation No
Secondary State-Trait Anxiety Inventory Measure of state and trait anxiety 4 months after implantation No
Secondary State-Trait Anxiety Inventory Measure of state and trait anxiety 6 months after implantation No
Secondary State-Trait Anxiety Inventory Measure of state and trait anxiety 12 months after implantation No
Secondary Minnesota Living with Heart Failure questionnaire Evaluation of the quality of life in patients with heart failure 48 hours after implantation No
Secondary Minnesota Living with Heart Failure questionnaire Evaluation of the quality of life in patients with heart failure 2 weeks after implantation No
Secondary Minnesota Living with Heart Failure questionnaire Evaluation of the quality of life in patients with heart failure 2 months after implantation No
Secondary Minnesota Living with Heart Failure questionnaire Evaluation of the quality of life in patients with heart failure 4 months after implantation No
Secondary Minnesota Living with Heart Failure questionnaire Evaluation of the quality of life in patients with heart failure 6 months after implantation No
Secondary Minnesota Living with Heart Failure questionnaire Evaluation of the quality of life in patients with heart failure 12 months after implantation No
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