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

NCT02902458 | Completed

• 1 other identifier: P/2014/217
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Implantable Defibrillator User

Keywords

implantable cardioverter defibrillator; primary prevention; psychological follow-up; anxiety; depression; quality of life

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (18)

• Quality of life

  48 hours after implantation

• Quality of life

  2 weeks after implantation

• Quality of life

  2 months after implantation

• Quality of life

  4 months after implantation

• Quality of life

  6 months after implantation

Study Arms (2)

Psychological follow-up

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up.

Interventions

Individual interview with a qualified psychologist OTHER

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.

Psychological follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients under legal tutorship or guardianship
• patients with no social security coverage
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besancon

Besançon, Besancon, 25000, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alexandre Guignier, MD

  Centre Hospitalier Universitaire de Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 15, 2016
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)