Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-02-06 @ 1:31 AM
Study NCT ID:
NCT03188861
Status:
UNKNOWN
Last Update Posted:
2018-07-18
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental health conditions', 'timeFrame': 'Baseline', 'description': 'Proportion of patients with a high self-reported symptom burden for at least one of four mental conditions: depression, anxiety disorders, somatoform disorders, alcohol abuse'}], 'secondaryOutcomes': [{'measure': 'Prevalence of mental disorders', 'timeFrame': 'Baseline', 'description': 'Prevalence of mental disorders as assessed by structured clinical interview'}, {'measure': 'Health outcomes', 'timeFrame': '6-months follow-up', 'description': 'Patient-reported health outcomes after 6 months ((Mental health conditions: Depression, anxiety, somatoform symptoms, alcohol abuse) and Quality of life)'}, {'measure': 'Utilization of health care systems', 'timeFrame': 'Baseline', 'description': 'Frequency of health care system utilization before ED visit'}, {'measure': 'Utilization of health care systems', 'timeFrame': '6-months follow-up', 'description': 'Frequency of health care system utilization after ED visit'}, {'measure': 'Expectations towards ED-care, semi-structured qualitative interviews', 'timeFrame': 'Baseline', 'description': 'Patient (n≈30) and providers (n≈30) expectations towards ED-care and psychological care, assessed in a qualitative interview and categorized on the basis of qualitative methods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental health conditions in ACSC patients', 'multimorbidity', 'health care utilization'], 'conditions': ['Depression', 'Anxiety', 'Somatoform Disorders', 'Alcohol Abuse']}, 'referencesModule': {'references': [{'pmid': '36739382', 'type': 'DERIVED', 'citation': 'Schneider A, Wagenknecht A, Sydow H, Riedlinger D, Holzinger F, Figura A, Deutschbein J, Reinhold T, Pigorsch M, Stasun U, Schenk L, Mockel M. Primary and secondary data in emergency medicine health services research - a comparative analysis in a regional research network on multimorbid patients. BMC Med Res Methodol. 2023 Feb 4;23(1):34. doi: 10.1186/s12874-023-01855-2.'}, {'pmid': '34289829', 'type': 'DERIVED', 'citation': 'Schneider A, Riedlinger D, Pigorsch M, Holzinger F, Deutschbein J, Keil T, Mockel M, Schenk L. Self-reported health and life satisfaction in older emergency department patients: sociodemographic, disease-related and care-specific associated factors. BMC Public Health. 2021 Jul 21;21(1):1440. doi: 10.1186/s12889-021-11439-8.'}], 'seeAlsoLinks': [{'url': 'http://emanet.charite.de', 'label': 'project web page'}]}, 'descriptionModule': {'briefSummary': 'EMASPOT assesses the prevalence and impact of mental health conditions in multimorbid emergency patients with cardiac ACSC on transsectoral utilisation of health care services.', 'detailedDescription': 'The specific aims of EMASPOT are primarily to determine the prevalence of mental health conditions (MHC) (i.e., symptoms of depression, anxiety, somatoform disorders, and alcohol abuse) in patients with multimorbidity and cardiac ACSC in a prospective cohort study.\n\nThe study population comprises patients admitted to an ED in Berlin-Mitte during the study period from 01.06.2017 to 31.05.2018 with cardiac complaints who are admitted to the hospital or discharged from ED. The study focusses especially on older and multimorbid patients. Multimorbidity is defined as the presence of more than two chronic diagnoses.\n\nAfter having given informed consent patients are enrolled in the study and interviewed by a study nurse. Self-reported symptom burden for depression, anxiety disorders, somatoform disorders, alcohol abuse as well as frequency of utilization of health care services are assessed. Medical data will be abstracted from medical charts and include somatic comorbidities, medication and diagnostic procedures and interventions during hospitalization.\n\nIndividual semi-structured interviews will be conducted with 30 patients to assess the treatment expectations and underlying motives for ED-visits, as well as with 30 health care professionals to investigate perceptions of challenges regarding identification and treatment of patients with MHC.\n\nAll patients will have a 6-months follow-up after discharge from the ED. The follow-up is conducted either by telephone calls, e-mail or via mail. The follow-up data will include mental health conditions as assessed at baseline, frequency of utilization of health care services and health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population comprises patients admitted to an ED in Berlin-Mitte during the study period from 01.06.2017 to 31.05.2018 with cardiac complaints who are admitted to the hospital or discharged from ED. The study focusses especially on older and multimorbid patients. Multimorbidity is defined as the presence of more than two chronic diagnoses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting to one of the EDs in Berlin-Mitte due to cardiac complaints (acute heart failure, angina pectoris, dyspnea, arrhythmias)\n* Age 50 and older\n\nExclusion Criteria:\n\n* Age 49 and younger\n* Inability to give written informed consent (cognitive impairment, legal guardianship)\n* Insufficient language skills to complete the questionnaire in one of the provided languages (German, English, Russian, Turkish)'}, 'identificationModule': {'nctId': 'NCT03188861', 'acronym': 'EMASPOT', 'briefTitle': 'Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Systematic Screening for Comorbid Psychological Conditions in Cardiac Ambulatory Care Sensitive Conditions (ACSC) Patients With Multimorbidity in the Emergency Departments (ED)', 'orgStudyIdInfo': {'id': 'EA1/363/16'}, 'secondaryIdInfos': [{'id': '0133/17/ST3', 'type': 'OTHER', 'domain': 'Corporate Data Protection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Möckel, Prof. Dr.', 'role': 'CONTACT', 'email': 'martin.moeckel@charite.de', 'phone': '004930450553472'}], 'facility': 'Division of Emergency Medicine, Charité University Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Martin Möckel, Prof. Dr.', 'role': 'CONTACT', 'email': 'martin.moeckel@charite.de', 'phone': '004930450553472'}, {'name': 'Stella Kuhlmann, MSc', 'role': 'CONTACT', 'email': 'stella.kuhlmann@charite.de', 'phone': '004930450553307'}], 'overallOfficials': [{'name': 'Martin Möckel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Emergency Medicine, Charité University Hospital Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Martin Moeckel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}