- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Martin Möckel, Prof. Dr.
- Telefonnummer: 004930450553472
- E-post: martin.moeckel@charite.de
Studera Kontakt Backup
- Namn: Stella Kuhlmann, MSc
- Telefonnummer: 004930450553307
- E-post: stella.kuhlmann@charite.de
Studieorter
-
-
-
Berlin, Tyskland
- Rekrytering
- Division of Emergency Medicine, Charité University Hospital
-
Kontakt:
- Martin Möckel, Prof. Dr.
- Telefonnummer: 004930450553472
- E-post: martin.moeckel@charite.de
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mental health conditions
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Prevalence of mental disorders
Tidsram: Baseline
|
Prevalence of mental disorders as assessed by structured clinical interview
|
Baseline
|
Health outcomes
Tidsram: 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
Tidsram: Baseline
|
Frequency of health care system utilization before ED visit
|
Baseline
|
Utilization of health care systems
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Martin Möckel, Prof. Dr., Division of Emergency Medicine, Charité University Hospital Berlin
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EA1/363/16
- 0133/17/ST3 (Annan identifierare: Corporate Data Protection)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Depression
-
ProgenaBiomeRekryteringDepression | Depression, postpartum | Depression, ångest | Depression Måttlig | Depression Svår | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskFörenta staterna
-
University of California, San FranciscoRekryteringDepression Måttlig | Depression Mild | Depression, tonåringFörenta staterna
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.Rekrytering
-
Washington University School of MedicineAvslutadBehandling Resistent depression | Senlivsdepression | Geriatrisk depression | Refraktär depression | Terapiresistent depressionFörenta staterna, Kanada
-
Baylor College of MedicineUniversity of TexasRekryteringDepression | Depression Måttlig | Depression Svår | Självmord och självskada | Depression i tonåren | Depression MildFörenta staterna
-
University of Cape TownNational Institute of Mental Health (NIMH)AvslutadPostpartum depression | Klinisk depression | Måttlig depressionSydafrika
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoAvslutadDepression Måttlig | Depression MildFörenta staterna, Dominikanska republiken
-
Gerbera Therapeutics, Inc.Har inte rekryterat ännuPostpartum depression | Depression, postpartum | Postnatal depression | Post-partum depression | Post-Natal depressionFörenta staterna
-
Federal Research Center of Fundamental and Translational...AvslutadDepression Måttlig | Depression MildRyska Federationen
-
Charite University, Berlin, GermanyAvslutadBehandling Resistent depression | Depression, unipolär | Depression KroniskTyskland