HEAlth Dialogues for Patients With Mental Illness in Primary Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Significance: The effect of Health Dialogues in patients with mental illness is not studied yet. The current fast implementation of the method in the primary care in south of Sweden (the region of Scania) provides a unique opportunity to study this patient group and the expected benefits of Health Dialogues in the long term, to study a potentially useful risk biomarker (copeptin) as well as to build a biobank for future studies on cardiovascular prognostic risk markers.

Official Title
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HEAlth Dialogues for Patients With Mental Illness in Primary Care

Conditions
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Mental Illness, Stress, Fatigue, Sleep Disorder, Depression, Diabetes, Myocardial Disease, Stroke, Death

Intervention / Treatment
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* Behavioral: health dialogue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems Exclusion Criteria: Dementia, not speaking, writing or understanding spoken the Swedish language.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health dialogue<br>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 | Behavioral: health dialogue<br>* The visual health assessment formulary is based on detailed questions about food, physical activity, heredity, smoking, alcohol, stress and mental illness and measurements such as BMI, blood pressure and blood fats. Patients fill in a web-based questionnaire resulting in a visual colorful scale showing a risk assessment (Figure 1). The Health Dialogue is a prognostic tool that provides an estimate of the increase in risk with current lifestyle habits. The use has shown improvement of lifestyle habits such as smoking cessation, lower intake of fat and higher physical activity level as well as reduced mortality in a long-term follow-up.<br>* Other names: The health curve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who change their risk profile | 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. | 24 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported risk change | Proportion of patients who had change between baseline and follow-up in self-reported lifestyle risk assessment | At 12 and 24 months from baseline | 
| Proportion of smokers and number of cigarettes per day | Proportion of patients, self-reported answers about smoking, Yes (number of cigarettes per day) no, or former | At baseline and follow-up at 12 and 24 months from baseline. | 
| Referral to smoking cessation | Proportion of patients who have undergone smoking cessation | At 12 and 24 months from baseline | 
| Time and intensity in physical activity | Proportion of patients in number of minutes self-reported in physical activity per week in different intensity | At baseline and follow-up at 12 and 24 months from baseline. | 
| Referral PaR-S | Proportion of patients who have received PaR-S | At 12 and 24 months from baseline | 
| Referral physiotherapist | Proportion of patients who have received referral to physiotherapist | At 12 and 24 months from baseline | 
| Alcohol consumption | Proportion of patients, self-reported number of glasses with 4 cl 40% alcohol per week | At baseline and follow-up at 12 and 24 months from baseline. | 
| Metabolic markers | Overnight fasting venous blood sampling. Change in mmol/L from baseline to follow-up of metabolic markers; total cholesterol, triglycerides, high density lipids (HDL), and low density lipids (LDL) | At 12 and 24 months from baseline | 
| Referral dietitian | Proportion of patients who have received referral to dietitian | At 12 and 24 months from baseline | 
| Proportion lost to follow-up | Proportion of dropouts / missed follow-ups | At 12 and 24 months from baseline | 
| Proportion of patients affected with type 2 diabetes | Long time follow-up in registers. Proportion of patients affected of type 2 diabetes: Diagnosis and date of onset of type 2 diabetes mellitus (ICD 10: E11). | From baseline and up to 20 years follow-up | 
| Proportion of patients affected with myocardial infarction | Long time follow-up in registers. Proportion of patients affected with myocardial infarction: Diagnosis and date of onset of myocardial infarction (MI) (I21) | From baseline and up to 20 years follow-up | 
| Proportion of patients affected with ischemic stroke | Long time follow-up in registers. Proportion of patients affected of ischemic stroke: Diagnosis and date of onset of ischemic stroke (I63) | From baseline and up to 20 years follow-up | 
| Proportion of deaths | Long time follow-up in registers. Proportion of patients. Diagnosis and date of death | From baseline and up to 20 years follow-up | 
| Proportion of cardiovascular death | Long time follow-up in registers. Proportion of patients affected of cardiovascular death: Diagnosis and date of onset of death, cardiovascular death (ICD 10: I) | From baseline and up to 20 years follow-up | 
| Proportion of patients affected with venous thromboembolism | Long time follow-up in registers. Proportion of patients affected of : Diagnosis and date of onset of venous thromboembolism (I82.0-I82.3, I82.8, I82.9 & I82.8W) | From baseline and up to 20 years follow-up | 
| Proportion of patients affected by MACE (Myocardial infarction, stroke or cardiovascular death) | Long time follow-up in registers. Proportion of patients affected of Myocardial infarction, stroke or cardiovascular death (MACE) up to 20 years from baseline: Diagnosis and date of first onset of ischemic stroke (I63), death, cardiovascular death (ICD 10: I), combined to the composite outcome measure MACE (MI, stroke or cardiovascular death). | From baseline and up to 20 years follow-up | 
| Co-peptin | Measured at baseline in pmol/L. Blood sampling after overnight fasting. | At baseline and follow-up at 12 and 24 months from baseline. | 
| Blood glucose | Fasting blood glucose from venous blood sampling in mmol/L | At baseline and follow-up at 12 and 24 months from baseline. | 
| BMI | BMI (weight and height will be combined to report BMI in kg/m^2) | At baseline and follow-up at 12 and 24 months from baseline. | 
| Waist hip ratio (WHR) | WHR will be calculated by the ratio between waist in cm and and hip in cm | At baseline and follow-up at 12 and 24 months from baseline. | 
| Blood pressure | Measured (mmHg), sitting at right arm after 10 minutes of resting with both feet on the floor. | At baseline and follow-up at 12 and 24 months from baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary health care, health dialogue, long-term follow-up, mental illness