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
• 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

• Implantable Defibrillator User

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