Observational Study with Historic Control Cohort of the Implementation of a Tool for Reduction of Cardiovascular Risk in Patients with Severe Mental Disorders
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
- 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:
-
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)
-
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)
-
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
Petter Andreas Ringen
Avdelingsoverlege
Oslo University Hospital
