- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01176929
Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt (OSTA)
Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts
The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.
The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.
The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.
연구 개요
상세 설명
This is a randomized, controlled and prospective trial comparing an experimental group (usual treatment + interventions) to a control group (usual treatment only). All participants are evaluated after one year of monitoring. The search duration is 2 years (one inclusion year and one year of follow-up). It is planned to include 330 patients, 165 patients in each group.
The program (experimental group) includes three interventions:
- A series of three telephone calls ( the second week , one month and three months after discharge from hospital )
- A systematic telephone contact with the referring physician
- A telephone helpline for people who made a suicide attempt and referring physicians.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Le Kremlin Bicetre, 프랑스, 94275
- Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults ≥ 18 years.
- Patients admitted to the emergency department for a suicide attempt.
- Patients referred to outpatient care.
- Patients who have given their written consent.
Exclusion Criteria:
- Patients not affiliated to social security.
- Patients do not have the faculties needed to be evaluated (cognitive or delusional disorder).
- Patients hospitalized for longer than 72 hours.
- Patients can not be recalled by phone (no phone, homeless, incarcerated)
- Patients who do not speak French.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Interventional group
Usual treatment + prevention program of recurrent suicidal acts
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Prevention program of recurrent suicidal acts includes three interventions:
다른 이름들:
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활성 비교기: Control group
Usual treatment
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Usual Treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
suicidal act frequency
기간: 12 months
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The primary endpoint is the occurrence of a suicidal act (occurrence or not).
The suicidal act includes suicide and suicide attempt.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
suicide attempts frequency
기간: 12 months
|
Number of occurrence of suicide attempts.
|
12 months
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Adherence to health care
기간: 12 months
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Adherence to health care: Defined by:
|
12 months
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Number of eligibles persons
기간: 12 months
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Number of eligibles persons: Number of people (among all people admitted to the emergency department fo a suicide attempt) meeting the criteria of selection. |
12 months
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Number of participants responding to telephone calls
기간: 12 months
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Number of participants responding to telephone calls: We consider the failure to call after three unsuccessful telephone calls to three different days. |
12 months
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Number of people lost sight of
기간: 12 months
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Number of people lost sight of: A person is considered lost sight if no information can be obtained after contact with the person himself, a third (nearest designated), a doctor (general practitioner and / or psychiatrist) and the nearest emergency department. |
12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Arnaud MARCHAND, MD, Assistance Publique - Hôpitaux de Paris
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- OST08017
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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