- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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)
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
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Berlin, 독일
- 모병
- Division of Emergency Medicine, Charité University Hospital
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연락하다:
- Martin Möckel, Prof. Dr.
- 전화번호: 004930450553472
- 이메일: martin.moeckel@charite.de
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mental health conditions
기간: 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
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Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Prevalence of mental disorders
기간: Baseline
|
Prevalence of mental disorders as assessed by structured clinical interview
|
Baseline
|
|
Health outcomes
기간: 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
|
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Utilization of health care systems
기간: Baseline
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Frequency of health care system utilization before ED visit
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Baseline
|
|
Utilization of health care systems
기간: 6-months follow-up
|
Frequency of health care system utilization after ED visit
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6-months follow-up
|
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Expectations towards ED-care, semi-structured qualitative interviews
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Martin Möckel, Prof. Dr., Division of Emergency Medicine, Charité University Hospital Berlin
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EA1/363/16
- 0133/17/ST3 (기타 식별자: Corporate Data Protection)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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