Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT04474418
Status:
UNKNOWN
Last Update Posted:
2020-07-16
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychometric Characterization of Patients With Cardiac Arrhythmias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory (BDI) - Change from Baseline at 6 months', 'timeFrame': 'From Baseline at 6 months (Follow-up) after standard therapy', 'description': 'BDI is a questionnaire measuring depression'}], 'secondaryOutcomes': [{'measure': 'NEO-FFI personality inventory', 'timeFrame': 'Only at baseline', 'description': 'personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness'}, {'measure': 'Electrocardiography (ECG) - Change from Baseline at 6 months', 'timeFrame': 'From Baseline at 6 months (Follow-up) after standard therapy', 'description': 'measuring heart activity and signs of cardiac arrhythmias'}, {'measure': 'Heart beat Counting Task by Schandry', 'timeFrame': 'Baseline', 'description': 'Assessment of patients heart beat perception'}, {'measure': 'Angstkontrollfragebogen (AKF) - Baseline', 'timeFrame': 'Baseline before standard therapy', 'description': 'AKF is the German Version of the Anxiety Control Questionnaire'}, {'measure': 'Angstkontrollfragebogen (AKF) - 3 months after standard therapy', 'timeFrame': '3 months after standard therapy', 'description': 'AKF is the German Version of the Anxiety Control Questionnaire'}, {'measure': 'Angstkontrollfragebogen (AKF) - 6 months after standard therapy', 'timeFrame': '6 months after standard therapy', 'description': 'AKF is the German Version of the Anxiety Control Questionnaire'}, {'measure': 'Anxiety Sensitivity Index (ASI) - Baseline Anxiety Sensitivity Index (ASI)', 'timeFrame': 'Baseline', 'description': 'ASI is a Questionnaire measuring anxiety sensitivity'}, {'measure': 'Anxiety Sensitivity Index (ASI) - 3 months after standard therapy Anxiety Sensitivity Index (ASI)', 'timeFrame': '3 months after standard therapy', 'description': 'ASI is a Questionnaire measuring anxiety sensitivity'}, {'measure': 'Anxiety Sensitivity Index (ASI) - 6 months after standard therapy Anxiety Sensitivity Index (ASI)', 'timeFrame': '6 months after standard therapy', 'description': 'ASI is a Questionnaire measuring anxiety sensitivity'}, {'measure': 'Beck Anxiety Inventory (BAI) - Change from Baseline at 6 months', 'timeFrame': 'From Baseline at 6 months (Follow-up) after standard therapy', 'description': 'BAI is a questionnaire measuring anxiety'}, {'measure': 'Heart rate variability - Baseline', 'timeFrame': 'Baseline before standard therapy', 'description': 'heart rate variability is a non-invasive method to measure autonomic nervous system function'}, {'measure': 'Heart rate variability - 3 months after standard therapy', 'timeFrame': '3 months after standard therapy', 'description': 'heart rate variability is a non-invasive method to measure autonomic nervous system function'}, {'measure': 'Heart rate variability - 6 months after standard therapy', 'timeFrame': '6 months after Standardtherapie', 'description': 'heart rate variability is a non-invasive method to measure autonomic nervous system function'}, {'measure': 'Resilienzskala (RS-13) - Baseline', 'timeFrame': 'Baseline', 'description': 'Questionnaire to measure resilience'}, {'measure': 'Resilienzskala (RS-13) - 3 months after standard therapy', 'timeFrame': '3 months after standard therapy', 'description': 'Questionnaire to measure resilience'}, {'measure': 'Resilienzskala (RS-13) - 6 months after standard therapy', 'timeFrame': '6 months after standard therapy', 'description': 'Questionnaire to measure resilience'}, {'measure': 'Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - Baseline', 'timeFrame': 'Baseline', 'description': 'Questionnaire to measure self-efficacy'}, {'measure': 'Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 3 months after standard therapy', 'timeFrame': '3 months after standard therapy', 'description': 'Questionnaire to measure self-efficacy'}, {'measure': 'Skala zur allgemeinen Selbstwirksamkeitserwartung (SWE) - 6 months after standard therapy', 'timeFrame': '6 months after standard therapy', 'description': 'Questionnaire to measure self-efficacy'}, {'measure': 'ICD-10-Symptom-Rating (ISR) - Change from Baseline at 6 months', 'timeFrame': 'From Baseline at 6 months after standard therapy', 'description': 'Questionnaire to assess symptoms of psychiatric disorders'}, {'measure': 'Perceived Stress Questionnaire (PSQ) - Change from Baseline at 6 months', 'timeFrame': 'From Baseline at 6 months after standard therapy', 'description': 'Questionnaire to measure psychological stress perception'}, {'measure': 'Body Sensations Questionnaire (BSQ) - Change from Baseline at 6 months', 'timeFrame': 'From Baseline at 6 months after standard therapy', 'description': 'Questionnaire to measure body sensations related to anxiety'}, {'measure': 'Herzangstfragebogen (HAF-17) - Change from Baseline at 6', 'timeFrame': 'From Baseline at 6 months after standard therapy', 'description': 'Questionnaire to measure anxiety with respect to cardiac symptoms'}, {'measure': 'Fragebogen zu Akzeptanz und Handeln II (FAH-II) - Change from Baseline at 6 months', 'timeFrame': 'From Baseline at 6 months after standard therapy', 'description': 'Questionnaire to measure psychological flexibility'}, {'measure': 'Euroquol EQ-5D-3L - Change from Baseline at 6', 'timeFrame': 'From Baseline at 6 months after standard therapy', 'description': 'Questionnaire to measure quality of life'}, {'measure': 'Unsicherheitsintoleranzfragebogen (UI-18)', 'timeFrame': 'Baseline', 'description': 'Questionnaire to measure tolerance to uncertainty'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac arrhythmia, personality, psychological symptoms'], 'conditions': ['Cardiac Arrhythmia', 'Anxiety', 'Personality', 'Psychological Stress', 'Depression']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with cardiac arrythmias without any signs of medium or severe cognitive dysfunction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of majority (min. 18 years old)\n* no severe cognitive dysfunction\n* diagnosed cardiac arrhythmias\n* reason of admission is the treatment of cardiac arrhythmia\n\nExclusion Criteria:\n\n* medium to severe cognitive dysfunction\n* doubt on capacity to give consent'}, 'identificationModule': {'nctId': 'NCT04474418', 'acronym': 'Be-PART', 'briefTitle': 'Psychometric Characterization of Patients With Cardiac Arrhythmias', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Be-PART: Berlin Psychometric Characterization of Patients With Cardiac ARrhyThmias', 'orgStudyIdInfo': {'id': 'EA2/211/17'}}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jens Plag, Dr.', 'role': 'CONTACT', 'email': 'jens.plag@charite.de', 'phone': '0049 30 450 517306'}], 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Jens Plag, Dr.', 'role': 'CONTACT', 'email': 'jens.plag@charite.de', 'phone': '+49 30 450 510 306'}, {'name': 'Martin Huemer, Dr.', 'role': 'CONTACT', 'email': 'martin.huemer@charite.de'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Jens Plag', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}