- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00969384
Physical Health of Residents in Psychiatric Institutions
Aim of the study: To investigate if the intervention described in this protocol has an effect on patients' and staff's physical health.
Null hypothesis: There is no difference in waist circumference, body weight, quality of life and the rate of polypharmacy between the intervention and control groups after six months.
연구 개요
상세 설명
Background:
The prevalence of physical health problems among patients suffering from psychiatric illnesses is above that seen in the average population (1). Cardiovascular diseases (2) and metabolic disorders (3;4) are common in persons diagnosed with schizophrenia (5;6). A fact that has been known for many years (7), and there has been no decrease in the prevalence of physical illness in connection with the decentralization of the psychiatric treatment which has taken place in the Western world during the last 30-40 years (8).
Meta-analyses describe increased physical morbidity among patients with psychiatric diseases and increased mortality on account of somatic diseases (7). One of the reasons for the increased mortality could be the use of second generation antipsychotics that in some cases cause weight gain and metabolic syndrome which is associated with a two to threefold increase in cardiovascular mortality and a twofold increase in all-cause mortality (3;9). These effects would be expected to contribute to even higher mortality in the following years (10).
The use of more than one antipsychotic drug, polypharmacy, might also play a role (11;12). Psychiatric societies, national and international health authorities advise against the use of polypharmacy (13).
The quality of the general health care in patients with severe mental illness and the consensus about the prevention of somatic illness in this group of vulnerable patients need to be improved and there is evidence signifying the importance of the situation (14;15).
We need more knowledge about how to integrate the prevention and care of somatic illness to this group of patients with severe psychiatric illness.
This study investigates ways to improve the physical health of people with a psychiatric diagnosis.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Aalborg, 덴마크, 9000
- Enheden for psykiatrisk forskning
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Living in one of the 6 institutions in Region Nordjylland
Exclusion Criteria:
- Not capable of speaking Danish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: waist circumferences
Intervention (active awareness): In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided. |
Intervention (active awareness): In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided. |
실험적: Lifestyle counseling
Intervention (active awareness): In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided. |
Intervention (active awareness): In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
waist circumferences
기간: 9 months
|
9 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Peter Mr Hjorth, MPH, Unit for psychiatric research North Jutland
- 연구 책임자: Povl Mr Munk Joergensen, Professor, Unit for psychiatric research North Jutland
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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 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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