- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188861
Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED (EMASPOT)
Systematic Screening for Comorbid Psychological Conditions in Cardiac Ambulatory Care Sensitive Conditions (ACSC) Patients With Multimorbidity in the Emergency Departments (ED)
Study Overview
Status
Conditions
Detailed Description
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.
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.
After 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.
Individual 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.
All 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Martin Möckel, Prof. Dr.
- Phone Number: 004930450553472
- Email: martin.moeckel@charite.de
Study Contact Backup
- Name: Stella Kuhlmann, MSc
- Phone Number: 004930450553307
- Email: stella.kuhlmann@charite.de
Study Locations
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-
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Berlin, Germany
- Recruiting
- Division of Emergency Medicine, Charité University Hospital
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Contact:
- Martin Möckel, Prof. Dr.
- Phone Number: 004930450553472
- Email: martin.moeckel@charite.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients presenting to one of the EDs in Berlin-Mitte due to cardiac complaints (acute heart failure, angina pectoris, dyspnea, arrhythmias)
- Age 50 and older
Exclusion Criteria:
- Age 49 and younger
- Inability to give written informed consent (cognitive impairment, legal guardianship)
- Insufficient language skills to complete the questionnaire in one of the provided languages (German, English, Russian, Turkish)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental health conditions
Time Frame: Baseline
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of mental disorders
Time Frame: Baseline
|
Prevalence of mental disorders as assessed by structured clinical interview
|
Baseline
|
Health outcomes
Time Frame: 6-months follow-up
|
Patient-reported health outcomes after 6 months ((Mental health conditions: Depression, anxiety, somatoform symptoms, alcohol abuse) and Quality of life)
|
6-months follow-up
|
Utilization of health care systems
Time Frame: Baseline
|
Frequency of health care system utilization before ED visit
|
Baseline
|
Utilization of health care systems
Time Frame: 6-months follow-up
|
Frequency of health care system utilization after ED visit
|
6-months follow-up
|
Expectations towards ED-care, semi-structured qualitative interviews
Time Frame: Baseline
|
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
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martin Möckel, Prof. Dr., Division of Emergency Medicine, Charité University Hospital Berlin
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA1/363/16
- 0133/17/ST3 (Other Identifier: Corporate Data Protection)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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