Psychometric Characterization of Patients With Cardiac Arrhythmias (Be-PART)

July 15, 2020 updated by: Dr. Jens Plag, Charite University, Berlin, Germany

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI) - Change from Baseline at 6 months
Time Frame: From Baseline at 6 months (Follow-up) after standard therapy
BDI is a questionnaire measuring depression
From Baseline at 6 months (Follow-up) after standard therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NEO-FFI personality inventory
Time Frame: Only at baseline
personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness
Only at baseline
Electrocardiography (ECG) - Change from Baseline at 6 months
Time Frame: From Baseline at 6 months (Follow-up) after standard therapy
measuring heart activity and signs of cardiac arrhythmias
From Baseline at 6 months (Follow-up) after standard therapy
Heart beat Counting Task by Schandry
Time Frame: Baseline
Assessment of patients heart beat perception
Baseline
Angstkontrollfragebogen (AKF) - Baseline
Time Frame: Baseline before standard therapy
AKF is the German Version of the Anxiety Control Questionnaire
Baseline before standard therapy
Angstkontrollfragebogen (AKF) - 3 months after standard therapy
Time Frame: 3 months after standard therapy
AKF is the German Version of the Anxiety Control Questionnaire
3 months after standard therapy
Angstkontrollfragebogen (AKF) - 6 months after standard therapy
Time Frame: 6 months after standard therapy
AKF is the German Version of the Anxiety Control Questionnaire
6 months after standard therapy
Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)
Time Frame: Baseline
ASI is a Questionnaire measuring anxiety sensitivity
Baseline
Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)
Time Frame: 3 months after standard therapy
ASI is a Questionnaire measuring anxiety sensitivity
3 months after standard therapy
Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI)
Time Frame: 6 months after standard therapy
ASI is a Questionnaire measuring anxiety sensitivity
6 months after standard therapy
Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months
Time Frame: From Baseline at 6 months (Follow-up) after standard therapy
BAI is a questionnaire measuring anxiety
From Baseline at 6 months (Follow-up) after standard therapy
Heart rate variability - Baseline
Time Frame: Baseline before standard therapy
heart rate variability is a non-invasive method to measure autonomic nervous system function
Baseline before standard therapy
Heart rate variability - 3 months after standard therapy
Time Frame: 3 months after standard therapy
heart rate variability is a non-invasive method to measure autonomic nervous system function
3 months after standard therapy
Heart rate variability - 6 months after standard therapy
Time Frame: 6 months after Standardtherapie
heart rate variability is a non-invasive method to measure autonomic nervous system function
6 months after Standardtherapie
Resilienzskala (RS-13) - Baseline
Time Frame: Baseline
Questionnaire to measure resilience
Baseline
Resilienzskala (RS-13) - 3 months after standard therapy
Time Frame: 3 months after standard therapy
Questionnaire to measure resilience
3 months after standard therapy
Resilienzskala (RS-13) - 6 months after standard therapy
Time Frame: 6 months after standard therapy
Questionnaire to measure resilience
6 months after standard therapy
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline
Time Frame: Baseline
Questionnaire to measure self-efficacy
Baseline
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy
Time Frame: 3 months after standard therapy
Questionnaire to measure self-efficacy
3 months after standard therapy
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy
Time Frame: 6 months after standard therapy
Questionnaire to measure self-efficacy
6 months after standard therapy
ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months
Time Frame: From Baseline at 6 months after standard therapy
Questionnaire to assess symptoms of psychiatric disorders
From Baseline at 6 months after standard therapy
Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months
Time Frame: From Baseline at 6 months after standard therapy
Questionnaire to measure psychological stress perception
From Baseline at 6 months after standard therapy
Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months
Time Frame: From Baseline at 6 months after standard therapy
Questionnaire to measure body sensations related to anxiety
From Baseline at 6 months after standard therapy
Herzangstfragebogen (HAF-17) - Change from Baseline at 6
Time Frame: From Baseline at 6 months after standard therapy
Questionnaire to measure anxiety with respect to cardiac symptoms
From Baseline at 6 months after standard therapy
Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months
Time Frame: From Baseline at 6 months after standard therapy
Questionnaire to measure psychological flexibility
From Baseline at 6 months after standard therapy
Euroquol EQ-5D-3L - Change from Baseline at 6
Time Frame: From Baseline at 6 months after standard therapy
Questionnaire to measure quality of life
From Baseline at 6 months after standard therapy
Unsicherheitsintoleranzfragebogen (UI-18)
Time Frame: Baseline
Questionnaire to measure tolerance to uncertainty
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA2/211/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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