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Cardiac ArrhythmiaBe-PARTNCT04474418

Psychometric Characterization of Patients With Cardiac Arrhythmias

An observational study of Cardiac Arrhythmia and Anxiety, run by Charite University, Berlin, Germany at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the influence of different psychological parameters (e.g. depression, anxiety, personality traits, resilience, tolerance of uncertainty or heart beat perception) on treatment outcome and quality of life in patients with cardiac arrythmias. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrhythmia, Anxiety, Personality
How many people
150 participants
Where
1 siteGermany
Study dates
9 Oct 2018to 1 Aug 2021
How long will I take part?
6 Months
Phase
Observational
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

Study population: Patients diagnosed with cardiac arrythmias without any signs of medium or severe cognitive dysfunction.

Who may be able to join

  • Age of majority (min. 18 years old)
  • no severe cognitive dysfunction
  • diagnosed cardiac arrhythmias
  • reason of admission is the treatment of cardiac arrhythmia

Who cannot join

  • medium to severe cognitive dysfunction
  • doubt on capacity to give consent

Trial locations and contacts

1 site in 1 country.

Jens Plag, Dr. contact

+49 30 450 510 306

jens.plag@charite.de

Martin Huemer, Dr. contact

martin.huemer@charite.de

Germany1 site, 1 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

    Jens Plag, Dr., 0049 30 450 517306, jens.plag@charite.de

    Recruiting

Other trials in Germany

About this study

Official title: Be-PART: Berlin Psychometric Characterization of Patients With Cardiac ARrhyThmias

To investigate the influence of different psychological parameters (e.g. depression, anxiety, personality traits, resilience, tolerance of uncertainty or heart beat perception) on treatment outcome and quality of life in patients with cardiac arrythmias.

Read the detailed description

This longitudinal observational study examines patients with cardiac arrhythmia (such as atrial fibrillation or atrial flutter) who are undergoing a conventional standard therapy in the Department of Cardiology of the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin. To examine the impact of psychological symptoms such as anxiety, depression, resilience and risk factors (e.g. neuroticism) on cardiac treatment outcomes, patients are evaluated with a standardized psychological assessment including established questionnaires. The baseline observation is performed before the standard treatment of the arrhythmia (e.g. pharmacological treatment or electrophysiological methods). Follow-up observations are made 3 and 6 month after the cardiological intervention.

Keywords
cardiac arrhythmia, personality, psychological symptoms
Medical subject headings
Arrhythmias, Cardiac, Anxiety Disorders, Stress, Psychological, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beck Depression Inventory (BDI) - Change from Baseline at 6 months

    BDI is a questionnaire measuring depression

    Measured: From Baseline at 6 months (Follow-up) after standard therapy

Secondary outcomes (26)

  1. NEO-FFI personality inventory

    personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness

    Measured: Only at baseline

  2. Electrocardiography (ECG) - Change from Baseline at 6 months

    measuring heart activity and signs of cardiac arrhythmias

    Measured: From Baseline at 6 months (Follow-up) after standard therapy

  3. Heart beat Counting Task by Schandry

    Assessment of patients heart beat perception

    Measured: Baseline

  4. Angstkontrollfragebogen (AKF) - Baseline

    AKF is the German Version of the Anxiety Control Questionnaire

    Measured: Baseline before standard therapy

  5. Angstkontrollfragebogen (AKF) - 3 months after standard therapy

    AKF is the German Version of the Anxiety Control Questionnaire

    Measured: 3 months after standard therapy

  6. Angstkontrollfragebogen (AKF) - 6 months after standard therapy

    AKF is the German Version of the Anxiety Control Questionnaire

    Measured: 6 months after standard therapy

  7. Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)

    ASI is a Questionnaire measuring anxiety sensitivity

    Measured: Baseline

  8. Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)

    ASI is a Questionnaire measuring anxiety sensitivity

    Measured: 3 months after standard therapy

  9. Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI)

    ASI is a Questionnaire measuring anxiety sensitivity

    Measured: 6 months after standard therapy

  10. Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months

    BAI is a questionnaire measuring anxiety

    Measured: From Baseline at 6 months (Follow-up) after standard therapy

  11. Heart rate variability - Baseline

    heart rate variability is a non-invasive method to measure autonomic nervous system function

    Measured: Baseline before standard therapy

  12. Heart rate variability - 3 months after standard therapy

    heart rate variability is a non-invasive method to measure autonomic nervous system function

    Measured: 3 months after standard therapy

  13. Heart rate variability - 6 months after standard therapy

    heart rate variability is a non-invasive method to measure autonomic nervous system function

    Measured: 6 months after Standardtherapie

  14. Resilienzskala (RS-13) - Baseline

    Questionnaire to measure resilience

    Measured: Baseline

  15. Resilienzskala (RS-13) - 3 months after standard therapy

    Questionnaire to measure resilience

    Measured: 3 months after standard therapy

  16. Resilienzskala (RS-13) - 6 months after standard therapy

    Questionnaire to measure resilience

    Measured: 6 months after standard therapy

  17. Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline

    Questionnaire to measure self-efficacy

    Measured: Baseline

  18. Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy

    Questionnaire to measure self-efficacy

    Measured: 3 months after standard therapy

  19. Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy

    Questionnaire to measure self-efficacy

    Measured: 6 months after standard therapy

  20. ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months

    Questionnaire to assess symptoms of psychiatric disorders

    Measured: From Baseline at 6 months after standard therapy

  21. Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months

    Questionnaire to measure psychological stress perception

    Measured: From Baseline at 6 months after standard therapy

  22. Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months

    Questionnaire to measure body sensations related to anxiety

    Measured: From Baseline at 6 months after standard therapy

  23. Herzangstfragebogen (HAF-17) - Change from Baseline at 6

    Questionnaire to measure anxiety with respect to cardiac symptoms

    Measured: From Baseline at 6 months after standard therapy

  24. Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months

    Questionnaire to measure psychological flexibility

    Measured: From Baseline at 6 months after standard therapy

  25. Euroquol EQ-5D-3L - Change from Baseline at 6

    Questionnaire to measure quality of life

    Measured: From Baseline at 6 months after standard therapy

  26. Unsicherheitsintoleranzfragebogen (UI-18)

    Questionnaire to measure tolerance to uncertainty

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2020
  2. Study start9 Oct 2018
  3. Primary completion1 Jan 2021 (estimated)
  4. Study completion1 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04474418
Sponsor's protocol ID
EA2/211/17
Acronym
Be-PART
Status last verified
Jul 2020
First submitted
2 Jul 2020
Last updated
16 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrhythmia and Anxiety, run by Charite University, Berlin, Germany at 1 site in Germany.

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 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 2020. 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 Germany. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jens Plag, Dr. (+49 30 450 510 306, jens.plag@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory (BDI) - Change from Baseline at 6 months (time frame: From Baseline at 6 months (Follow-up) after standard therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04474418.

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 16 Jul 2020.

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