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临床试验/NCT06807242
NCT06807242已完成不适用

Observational Study with Historic Control Cohort of the Implementation of a Tool for Reduction of Cardiovascular Risk in Patients with Severe Mental Disorders

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
270
试验地点
1
主要终点
Waist circumference

研究概览

简要总结

Observational study of the implementation of a Norwegian adaptation of a tool for monitoring, detection and intervention of cardiovascular risk factors in severe mental disorders. The project investigates if the medical care is improved or the cardiovascular risk is reduced after implementation. Patients and service provision/clinical interventions is assessed at baseline and at 12 months, with a historic patient comparison group with the same assessments except for service provision/clinical interventions.

详细描述

  1. AIMS

This study aims at answering whether a Norwegian adaptation of a tool for monitoring, detection and intervention of cardiovascular risk factors (hereafter: the CMR-tool) may be effectively implemented and thus improve the care for this patient group, and ultimately reduce cardiovascular risk. Specific research questions:

  1. Is there any improvement in received services between units implementing the CMR-tool after one year compared to other non-implementation units and the same unit before implementation? (Health care assessment)

  2. Is there any improvement in patients' cardiovascular risk factors between units implementing the CMR-tool after one year compared to other non-implementation units and the same unit before implementation? (Patient related factors)

  3. MATERIAL AND METHODS 2.1 Sample and setting Mental Health Specialized Units: Out and inpatient departments providing services for patients with psychotic or psychosis-related conditions in the specialized health care service in Norway. Several university hospitals will cooperate. The implementation of the Tool will be a part of the hospitals' quality improvement work. The CMR-tool will be implemented sequentially in the different hospitals according to the capacity of the hospital organizations.

Community Care: The current project will include patients receiving treatment in the specialized health care system. However, many/all participants will be followed on somatic issues by the family doctors after discharge from hospital treatment/the specialized health care system.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18+. Diagnosis of ICD10 F2 or F3 and/or use of antipsychotics

排除标准

  • •inability to give informed consent

结局指标

主要结局

Waist circumference

时间窗: t=0 and t=12months

in cm

Physical Activity level

时间窗: t=0 and t=12months

Self report of hours in Activity or sedentary behavior or Level of intensity

Diet

时间窗: t=0 and t=12months

unhealthy diet,self report

NORRISK

时间窗: t=0 and t=12months

Composite score of cardiovascular risk

Blood pressure

时间窗: t=0 and t=12months

Systolic and diastolic blood pressure

Smoking status

时间窗: t=0 and t=12months

Smoking tobacco daily

BMI

时间窗: t=0 and t=12months

kg/m2

HbA1c

时间窗: t=0 and t=12months

Glucosylated hemoglobine

Blood lipids

时间窗: t=0 and t=12months

Tot-Cholesterol, HDL-Chol. LDL-Chol, Triglycerides

次要结局

  • Level of Medical care(t=0 (baseline) and t=12months)
  • Interventions for cardiovascular risk reduction(t=0 (baseline) and t=12months)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petter Andreas Ringen

Avdelingsoverlege

Oslo University Hospital

研究点 (1)

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