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

This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.

Study Overview

• Status: Completed
• Conditions: Implantable Defibrillator User
• Intervention / Treatment: Other: Individual interview with a qualified psychologist

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25000
    • CHU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychological follow-up; 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.	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.
No Intervention: Control; Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Alexandre Guignier, MD, Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; depression; anxiety; primary prevention; implantable cardioverter defibrillator; psychological follow-up
• Other Study ID Numbers: P/2014/217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO