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

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: Unknown
• Conditions: Depression; Anxiety; Cardiac Arrhythmia; Psychological Stress; Personality

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: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Jens Plag, Dr.; Phone Number: +49 30 450 510 306; Email: jens.plag@charite.de
• Study Contact Backup: Name: Martin Huemer, Dr.; Email: martin.huemer@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Jens Plag, Dr.; Phone Number: 0049 30 450 517306; Email: jens.plag@charite.de

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory (BDI) - Change from Baseline at 6 months	BDI is a questionnaire measuring depression	From Baseline at 6 months (Follow-up) after standard therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NEO-FFI personality inventory	personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness	Only at baseline
Electrocardiography (ECG) - Change from Baseline at 6 months	measuring heart activity and signs of cardiac arrhythmias	From Baseline at 6 months (Follow-up) after standard therapy
Heart beat Counting Task by Schandry	Assessment of patients heart beat perception	Baseline
Angstkontrollfragebogen (AKF) - Baseline	AKF is the German Version of the Anxiety Control Questionnaire	Baseline before standard therapy
Angstkontrollfragebogen (AKF) - 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	AKF is the German Version of the Anxiety Control Questionnaire	6 months after standard therapy
Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)	ASI is a Questionnaire measuring anxiety sensitivity	Baseline
Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)	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)	ASI is a Questionnaire measuring anxiety sensitivity	6 months after standard therapy
Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months	BAI is a questionnaire measuring anxiety	From Baseline at 6 months (Follow-up) after standard therapy
Heart rate variability - Baseline	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	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	heart rate variability is a non-invasive method to measure autonomic nervous system function	6 months after Standardtherapie
Resilienzskala (RS-13) - Baseline	Questionnaire to measure resilience	Baseline
Resilienzskala (RS-13) - 3 months after standard therapy	Questionnaire to measure resilience	3 months after standard therapy
Resilienzskala (RS-13) - 6 months after standard therapy	Questionnaire to measure resilience	6 months after standard therapy
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline	Questionnaire to measure self-efficacy	Baseline
Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 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	Questionnaire to measure self-efficacy	6 months after standard therapy
ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months	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	Questionnaire to measure psychological stress perception	From Baseline at 6 months after standard therapy
Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months	Questionnaire to measure body sensations related to anxiety	From Baseline at 6 months after standard therapy
Herzangstfragebogen (HAF-17) - Change from Baseline at 6	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	Questionnaire to measure psychological flexibility	From Baseline at 6 months after standard therapy
Euroquol EQ-5D-3L - Change from Baseline at 6	Questionnaire to measure quality of life	From Baseline at 6 months after standard therapy
Unsicherheitsintoleranzfragebogen (UI-18)	Questionnaire to measure tolerance to uncertainty	Baseline

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: cardiac arrhythmia, personality, psychological symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Stress, Psychological; Arrhythmias, Cardiac
• Other Study ID 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