DepressionEMASPOTNCT03188861
Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED
An observational study of Depression and Anxiety, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression, Anxiety, Somatoform Disorders
- How many people
- 650 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Division of Emergency Medicine, Charité University Hospital
Berlin
Martin Möckel, Prof. Dr., 004930450553472, martin.moeckel@charite.de
About this study
Official title: Systematic Screening for Comorbid Psychological Conditions in Cardiac Ambulatory Care Sensitive Conditions (ACSC) Patients With Multimorbidity in the Emergency Departments (ED)
EMASPOT assesses the prevalence and impact of mental health conditions in multimorbid emergency patients with cardiac ACSC on transsectoral utilisation of health care services.
Read the 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.
- Conditions
- Depression, Anxiety, Somatoform Disorders, Alcohol Abuse
- Keywords
- mental health conditions in ACSC patients, multimorbidity, health care utilization
- Medical subject headings
- Depression, Anxiety Disorders, Somatoform Disorders, Alcoholism, Patient Acceptance of Health Care
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (5)
Prevalence of mental disorders
Prevalence of mental disorders as assessed by structured clinical interview
Measured: Baseline
Health outcomes
Patient-reported health outcomes after 6 months ((Mental health conditions: Depression, anxiety, somatoform symptoms, alcohol abuse) and Quality of life)
Measured: 6-months follow-up
Utilization of health care systems
Frequency of health care system utilization before ED visit
Measured: Baseline
Utilization of health care systems
Frequency of health care system utilization after ED visit
Measured: 6-months follow-up
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Jun 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Martin Moeckel, Charite University, Berlin, Germany
- Investigators
- Martin Möckel, Prof. Dr., Principal investigator, Division of Emergency Medicine, Charité University Hospital Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188861
- Sponsor's protocol ID
- EA1/363/16
- Other IDs
- 0133/17/ST3
- Acronym
- EMASPOT
- Status last verified
- Jul 2018
- First submitted
- 31 May 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36739382Schneider 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.
PubMed 34289829
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Screening for Comorbid Psychological Conditions in Cardiac Ambulatory Care Sensitive Conditions (ACSC) Patients With Multimorbidity in the Emergency Departments (ED)
- ClinicalTrials.gov ID
- NCT03188861
- Acronym / sponsor ID
- EMASPOT / EA1/363/16
- Conditions
- Depression, Anxiety, Somatoform Disorders, Alcohol Abuse
- Keywords
- mental health conditions in ACSC patients, multimorbidity, health care utilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EMASPOT assesses the prevalence and impact of mental health conditions in multimorbid emergency patients with cardiac ACSC on transsectoral utilisation of health care services.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Prevalence of mental disorders
Time frame: Baseline
Health outcomes
Time frame: 6-months follow-up
Utilization of health care systems
Time frame: Baseline
Utilization of health care systems
Time frame: 6-months follow-up
Expectations towards ED-care, semi-structured qualitative interviews
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 36739382Schneider 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.
- Derived from this study: PubMed 34289829Schneider 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.
- project web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Möckel, Prof. Dr. principal investigator
Division of Emergency Medicine, Charité University Hospital Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Möckel, Prof. Dr. (004930450553472, martin.moeckel@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health conditions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188861, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.