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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03188861
Other study ID # EA1/363/16
Secondary ID 0133/17/ST3
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date April 30, 2019

Study information

Verified date July 2018
Source Charite University, Berlin, Germany
Contact Martin Möckel, Prof. Dr.
Phone 004930450553472
Email martin.moeckel@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

EMASPOT assesses the prevalence and impact of mental health conditions in multimorbid emergency patients with cardiac ACSC on transsectoral utilisation of health care services.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 650
Est. completion date April 30, 2019
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Locations

Country Name City State
Germany Division of Emergency Medicine, Charité University Hospital Berlin

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mental health conditions 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 Prevalence of mental disorders Prevalence of mental disorders as assessed by structured clinical interview Baseline
Secondary Health outcomes Patient-reported health outcomes after 6 months ((Mental health conditions: Depression, anxiety, somatoform symptoms, alcohol abuse) and Quality of life) 6-months follow-up
Secondary Utilization of health care systems Frequency of health care system utilization before ED visit Baseline
Secondary Utilization of health care systems Frequency of health care system utilization after ED visit 6-months follow-up
Secondary Expectations towards ED-care, semi-structured qualitative interviews 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
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