Systematic Screening for Comorbid Psychological Condition... | NCT03188861

Studies
Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED

NCT03188861

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Jul 18, 2018Actual

Enrollment

650Estimated

Phase

Not provided

Conditions

Depression
Anxiety
Somatoform Disorders
Alcohol Abuse

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
0133/17/ST3	Other Identifier	Corporate Data Protection

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Aug 31, 2018Estimated

Completion Date

Apr 30, 2019Estimated

First Submitted Date

May 31, 2017

First Submission Date that Met QC Criteria

Jun 13, 2017

First Posted Date

Jun 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2018

Last Update Posted Date

Jul 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Moeckel, Prof. Dr., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

650Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Prevalence of mental disorders	Prevalence of mental disorders as assessed by structured clinical interview	Baseline
Health outcomes	Patient-reported health outcomes after 6 months ((Mental health conditions: Depression, anxiety, somatoform symptoms, alcohol abuse) and Quality of life)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martin Möckel, Prof. Dr.	Contact	004930450553472		martin.moeckel@charite.de
Stella Kuhlmann, MSc	Contact	004930450553307		stella.kuhlmann@charite.de

Overall Officials

Name	Affiliation	Role
Martin Möckel, Prof. Dr.	Division of Emergency Medicine, Charité University Hospital Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Emergency Medicine, Charité University Hospital	Recruiting	Berlin			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36739382	Derived	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.
34289829

ID	Term
D003863	Depression
D001008	Anxiety Disorders
D013001	Somatoform Disorders
D000437	Alcoholism
D010342	Patient Acceptance of Health Care

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders
D019973	Alcohol-Related Disorders