HEAlth Dialogues for Patients With Mental Illness in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Proportion of patients who change their risk profile
研究概览
简要总结
In the current project, primary health care patients with mental illness such as anxiety, depression, fatigue or sleep disorders will be followed. The study includes both health conversations with the health curve as a systematic work with lifestyle habits, and the biochemical risk marker copeptin with a focus on improved lifestyle habits and the development of cardiovascular complications. Participants will be followed up at 12 and 24 months with renewed health interview including the health curve and blood sampling. National registries will be used for a, up to 20 year long follow-up regarding cardiovascular complications and mortality.
详细描述
Patients with mental illness have an increased risk of cardiovascular morbidity and mortality compared to the rest of the population, partly related to unhealthy lifestyle habits. However, not all risk factors for developing cardiovascular disease are known yet. The interest in studies about the importance of copeptin as a biochemical risk factors has increased in recent years.
Objectives:
The main aim with this project is assessment of the effect of Health Dialogue with the health curve (in swedish; Hälsokurvan) on lifestyle habits and cardiovascular risk factors in patients with mental illness in primary care. The second aim is to assess copeptin's prognostic value and to collect blood samples in a biobank for future research on molecular biomarkers with prognostic value for cardiovascular disease.
Work plan:
The study has a prospective observational design. The method with Health Dialogues is previously validated in a Swedish context and is based on a detailed lifestyle questionnaire, blood testing and personalized counselling by a trained health care professional. The patients will be followed with a new Health Dialogue and blood samples after 12 and 24 months and for 20 years with National Registers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •patients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems
排除标准
- •Dementia, not speaking, writing or understanding spoken the Swedish language.
研究组 & 干预措施
Health dialogue
Patients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems) will be followed at 12 and 24 months from baseline in a first assessment, and after 5 and 10 years with follow-up in national registers in a later phase. The patient will fill out a web-based questionnaire about lifestyle habits before the visit to the health center and will be called for blood sampling and measurement of blood pressure and BMI. A nurse with special training in the Health Dialogue then meets the patient and provides individually tailored advice based on the patient's unique conditions and the risk profile on the Health Dialogue, such as help with smoking cessation, physical activity on prescription (PaR-S), contact with a dietitian, physiotherapist. A continued contact with a psychologist or physician will be planned if necessary
干预措施: health dialogue (Behavioral)
结局指标
主要结局
Proportion of patients who change their risk profile
时间窗: 24 months from baseline
Proportion of patients who achieve a change in the risk profile on the Health Dialogue. A positive change ("yes") is defined if a larger number of the variables on the Health Curve have improved than deteriorated. "No" is defined as no change or negative change has taken place.
次要结局
- Blood pressure(At baseline and follow-up at 12 and 24 months from baseline.)
- Referral physiotherapist(At 12 and 24 months from baseline)
- Proportion of cardiovascular death(From baseline and up to 20 years follow-up)
- Referral to smoking cessation(At 12 and 24 months from baseline)
- Time and intensity in physical activity(At baseline and follow-up at 12 and 24 months from baseline.)
- Referral PaR-S(At 12 and 24 months from baseline)
- Co-peptin(At baseline and follow-up at 12 and 24 months from baseline.)
- Proportion of smokers and number of cigarettes per day(At baseline and follow-up at 12 and 24 months from baseline.)
- Metabolic markers(At 12 and 24 months from baseline)
- Self reported risk change(At 12 and 24 months from baseline)
- Proportion lost to follow-up(At 12 and 24 months from baseline)
- Proportion of patients affected with type 2 diabetes(From baseline and up to 20 years follow-up)
- Proportion of deaths(From baseline and up to 20 years follow-up)
- Proportion of patients affected with venous thromboembolism(From baseline and up to 20 years follow-up)
- Proportion of patients affected with myocardial infarction(From baseline and up to 20 years follow-up)
- Waist hip ratio (WHR)(At baseline and follow-up at 12 and 24 months from baseline.)
- Referral dietitian(At 12 and 24 months from baseline)
- Alcohol consumption(At baseline and follow-up at 12 and 24 months from baseline.)
- Proportion of patients affected with ischemic stroke(From baseline and up to 20 years follow-up)
- Blood glucose(At baseline and follow-up at 12 and 24 months from baseline.)
- BMI(At baseline and follow-up at 12 and 24 months from baseline.)
- Proportion of patients affected by MACE (Myocardial infarction, stroke or cardiovascular death)(From baseline and up to 20 years follow-up)