Implantable Defibrillator UserPEACENCT02902458
Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study
A study testing Individual interview with a qualified psychologist in people with Implantable Defibrillator User, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Defibrillator User
- What is being tested?
- Individual interview with a qualified psychologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Implantable Defibrillator User
- Being tested
- Individual interview with a qualified psychologist
- Keywords
- implantable cardioverter defibrillator, primary prevention, psychological follow-up, anxiety, depression, quality of life
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual interview with a qualified psychologistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini International Neuropsychiatric Interview score
Measured: 48 hours after implantation
Mini International Neuropsychiatric Interview score
Measured: 2 weeks after implantation
Mini International Neuropsychiatric Interview score
Measured: 2 months after implantation
Mini International Neuropsychiatric Interview score
Measured: 4 months after implantation
Mini International Neuropsychiatric Interview score
Measured: 6 months after implantation
Mini International Neuropsychiatric Interview score
Measured: 12 months after implantation
Secondary outcomes (18)
Quality of life
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Measured: 48 hours after implantation
Quality of life
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Measured: 2 weeks after implantation
Quality of life
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Measured: 2 months after implantation
Quality of life
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Measured: 4 months after implantation
Quality of life
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Measured: 6 months after implantation
Quality of life
Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire
Measured: 12 months after implantation
State-Trait Anxiety Inventory
Measure of state and trait anxiety
Measured: 48 hours after implantation
State-Trait Anxiety Inventory
Measure of state and trait anxiety
Measured: 2 weeks after implantation
State-Trait Anxiety Inventory
Measure of state and trait anxiety
Measured: 2 months after implantation
State-Trait Anxiety Inventory
Measure of state and trait anxiety
Measured: 4 months after implantation
State-Trait Anxiety Inventory
Measure of state and trait anxiety
Measured: 6 months after implantation
State-Trait Anxiety Inventory
Measure of state and trait anxiety
Measured: 12 months after implantation
Minnesota Living with Heart Failure questionnaire
Evaluation of the quality of life in patients with heart failure
Measured: 48 hours after implantation
Minnesota Living with Heart Failure questionnaire
Evaluation of the quality of life in patients with heart failure
Measured: 2 weeks after implantation
Minnesota Living with Heart Failure questionnaire
Evaluation of the quality of life in patients with heart failure
Measured: 2 months after implantation
Minnesota Living with Heart Failure questionnaire
Evaluation of the quality of life in patients with heart failure
Measured: 4 months after implantation
Minnesota Living with Heart Failure questionnaire
Evaluation of the quality of life in patients with heart failure
Measured: 6 months after implantation
Minnesota Living with Heart Failure questionnaire
Evaluation of the quality of life in patients with heart failure
Measured: 12 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Defibrillator UserStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Guignier, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902458
- Sponsor's protocol ID
- P/2014/217
- Acronym
- PEACE
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study
- ClinicalTrials.gov ID
- NCT02902458
- Acronym / sponsor ID
- PEACE / P/2014/217
- Conditions
- Implantable Defibrillator User
- Keywords
- implantable cardioverter defibrillator, primary prevention, psychological follow-up, anxiety, depression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological follow-up | Experimental | Other: Individual interview with a qualified psychologistPatients undergoing implantation of an ICD for primary prevention will have an individual interview with a qualified psychologist in addition to standard medical follow-up. |
| Control | No intervention | –Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual interview with a qualified psychologistIndividual, 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. | Other | Psychological follow-up |
Primary outcome
Mini International Neuropsychiatric Interview score
Time frame: 48 hours after implantation
Mini International Neuropsychiatric Interview score
Time frame: 2 weeks after implantation
Mini International Neuropsychiatric Interview score
Time frame: 2 months after implantation
Mini International Neuropsychiatric Interview score
Time frame: 4 months after implantation
Mini International Neuropsychiatric Interview score
Time frame: 6 months after implantation
Mini International Neuropsychiatric Interview score
Time frame: 12 months after implantation
18 secondary outcomes
Quality of life
Time frame: 48 hours after implantation
Quality of life
Time frame: 2 weeks after implantation
Quality of life
Time frame: 2 months after implantation
Quality of life
Time frame: 4 months after implantation
Quality of life
Time frame: 6 months after implantation
Quality of life
Time frame: 12 months after implantation
State-Trait Anxiety Inventory
Time frame: 48 hours after implantation
State-Trait Anxiety Inventory
Time frame: 2 weeks after implantation
State-Trait Anxiety Inventory
Time frame: 2 months after implantation
State-Trait Anxiety Inventory
Time frame: 4 months after implantation
State-Trait Anxiety Inventory
Time frame: 6 months after implantation
State-Trait Anxiety Inventory
Time frame: 12 months after implantation
Minnesota Living with Heart Failure questionnaire
Time frame: 48 hours after implantation
Minnesota Living with Heart Failure questionnaire
Time frame: 2 weeks after implantation
Minnesota Living with Heart Failure questionnaire
Time frame: 2 months after implantation
Minnesota Living with Heart Failure questionnaire
Time frame: 4 months after implantation
Minnesota Living with Heart Failure questionnaire
Time frame: 6 months after implantation
Minnesota Living with Heart Failure questionnaire
Time frame: 12 months after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Guignier, MD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual interview with a qualified psychologist in people with Implantable Defibrillator User, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini International Neuropsychiatric Interview score (time frame: 48 hours after implantation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.