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Completed

NCT Number: NCT02902458

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Besancon

Besançon, Besancon, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mini International Neuropsychiatric Interview score

    Time frame: 48 hours after implantation

  2. Mini International Neuropsychiatric Interview score

    Time frame: 2 weeks after implantation

  3. Mini International Neuropsychiatric Interview score

    Time frame: 2 months after implantation

  4. Mini International Neuropsychiatric Interview score

    Time frame: 4 months after implantation

  5. Mini International Neuropsychiatric Interview score

    Time frame: 6 months after implantation

  6. Mini International Neuropsychiatric Interview score

    Time frame: 12 months after implantation

Secondary outcomes

  1. Quality of life

    Time frame: 48 hours after implantation

    Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire

  2. Quality of life

    Time frame: 2 weeks after implantation

    Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire

  3. Quality of life

    Time frame: 2 months after implantation

    Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire

  4. Quality of life

    Time frame: 4 months after implantation

    Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire

  5. Quality of life

    Time frame: 6 months after implantation

    Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire

  6. Quality of life

    Time frame: 12 months after implantation

    Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire

  7. State-Trait Anxiety Inventory

    Time frame: 48 hours after implantation

    Measure of state and trait anxiety

  8. State-Trait Anxiety Inventory

    Time frame: 2 weeks after implantation

    Measure of state and trait anxiety

  9. State-Trait Anxiety Inventory

    Time frame: 2 months after implantation

    Measure of state and trait anxiety

  10. State-Trait Anxiety Inventory

    Time frame: 4 months after implantation

    Measure of state and trait anxiety

  11. State-Trait Anxiety Inventory

    Time frame: 6 months after implantation

    Measure of state and trait anxiety

  12. State-Trait Anxiety Inventory

    Time frame: 12 months after implantation

    Measure of state and trait anxiety

  13. Minnesota Living with Heart Failure questionnaire

    Time frame: 48 hours after implantation

    Evaluation of the quality of life in patients with heart failure

  14. Minnesota Living with Heart Failure questionnaire

    Time frame: 2 weeks after implantation

    Evaluation of the quality of life in patients with heart failure

  15. Minnesota Living with Heart Failure questionnaire

    Time frame: 2 months after implantation

    Evaluation of the quality of life in patients with heart failure

  16. Minnesota Living with Heart Failure questionnaire

    Time frame: 4 months after implantation

    Evaluation of the quality of life in patients with heart failure

  17. Minnesota Living with Heart Failure questionnaire

    Time frame: 6 months after implantation

    Evaluation of the quality of life in patients with heart failure

  18. Minnesota Living with Heart Failure questionnaire

    Time frame: 12 months after implantation

    Evaluation of the quality of life in patients with heart failure

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: PEACE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2016
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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