Clinical trial NCT04474418: Psychometric Characterization of Patients With Cardiac Arrhythmias
Official title: Be-PART: Berlin Psychometric Characterization of Patients With Cardiac ARrhyThmias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmia
Anxiety
Personality
Psychological Stress
Depression
Keywords: cardiac arrhythmia, personality, psychological symptoms
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with cardiac arrythmias without any signs of medium or severe cognitive dysfunction.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beck Depression Inventory (BDI) - Change from Baseline at 6 months
timeFrame: From Baseline at 6 months (Follow-up) after standard therapy
Secondary outcomes:
measure: NEO-FFI personality inventory
timeFrame: Only at baseline
measure: Electrocardiography (ECG) - Change from Baseline at 6 months
timeFrame: From Baseline at 6 months (Follow-up) after standard therapy
measure: Heart beat Counting Task by Schandry
timeFrame: Baseline
measure: Angstkontrollfragebogen (AKF) - Baseline
timeFrame: Baseline before standard therapy
measure: Angstkontrollfragebogen (AKF) - 3 months after standard therapy
timeFrame: 3 months after standard therapy
measure: Angstkontrollfragebogen (AKF) - 6 months after standard therapy
timeFrame: 6 months after standard therapy
measure: Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)
timeFrame: Baseline
measure: Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)
timeFrame: 3 months after standard therapy
measure: Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI)
timeFrame: 6 months after standard therapy
measure: Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months
timeFrame: From Baseline at 6 months (Follow-up) after standard therapy
measure: Heart rate variability - Baseline
timeFrame: Baseline before standard therapy
measure: Heart rate variability - 3 months after standard therapy
timeFrame: 3 months after standard therapy
measure: Heart rate variability - 6 months after standard therapy
timeFrame: 6 months after Standardtherapie
measure: Resilienzskala (RS-13) - Baseline
timeFrame: Baseline
measure: Resilienzskala (RS-13) - 3 months after standard therapy
timeFrame: 3 months after standard therapy
measure: Resilienzskala (RS-13) - 6 months after standard therapy
timeFrame: 6 months after standard therapy
measure: Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline
timeFrame: Baseline
measure: Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy
timeFrame: 3 months after standard therapy
measure: Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy
timeFrame: 6 months after standard therapy
measure: ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months
timeFrame: From Baseline at 6 months after standard therapy
measure: Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months
timeFrame: From Baseline at 6 months after standard therapy
measure: Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months
timeFrame: From Baseline at 6 months after standard therapy
measure: Herzangstfragebogen (HAF-17) - Change from Baseline at 6
timeFrame: From Baseline at 6 months after standard therapy
measure: Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months
timeFrame: From Baseline at 6 months after standard therapy
measure: Euroquol EQ-5D-3L - Change from Baseline at 6
timeFrame: From Baseline at 6 months after standard therapy
measure: Unsicherheitsintoleranzfragebogen (UI-18)
timeFrame: Baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References: