Death, Depression, Diabetes, Fatigue, Mental Illness, Myocardial Disease, Sleep Disorder, Stress, Stroke
Conditions
Keywords
primary health care, health dialogue, long-term follow-up, mental illness
Brief summary
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
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.
Interventions
BEHAVIORALhealth dialogue
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.
Sponsors
Region Skane
Lund University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who change their risk profile | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self reported risk change | At 12 and 24 months from baseline | Proportion of patients who had change between baseline and follow-up in self-reported lifestyle risk assessment |
| Proportion of smokers and number of cigarettes per day | At baseline and follow-up at 12 and 24 months from baseline. | Proportion of patients, self-reported answers about smoking, Yes (number of cigarettes per day) no, or former |
| Referral to smoking cessation | At 12 and 24 months from baseline | Proportion of patients who have undergone smoking cessation |
| Time and intensity in physical activity | At baseline and follow-up at 12 and 24 months from baseline. | Proportion of patients in number of minutes self-reported in physical activity per week in different intensity |
| Referral PaR-S | At 12 and 24 months from baseline | Proportion of patients who have received PaR-S |
| Referral physiotherapist | At 12 and 24 months from baseline | Proportion of patients who have received referral to physiotherapist |
| Alcohol consumption | At baseline and follow-up at 12 and 24 months from baseline. | Proportion of patients, self-reported number of glasses with 4 cl 40% alcohol per week |
| Metabolic markers | At 12 and 24 months from baseline | 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) |
| Referral dietitian | At 12 and 24 months from baseline | Proportion of patients who have received referral to dietitian |
| Proportion lost to follow-up | At 12 and 24 months from baseline | Proportion of dropouts / missed follow-ups |
| Proportion of patients affected with type 2 diabetes | From baseline and up to 20 years follow-up | 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). |
| Proportion of patients affected with myocardial infarction | From baseline and up to 20 years follow-up | Long time follow-up in registers. Proportion of patients affected with myocardial infarction: Diagnosis and date of onset of myocardial infarction (MI) (I21) |
| Proportion of patients affected with ischemic stroke | From baseline and up to 20 years follow-up | Long time follow-up in registers. Proportion of patients affected of ischemic stroke: Diagnosis and date of onset of ischemic stroke (I63) |
| Proportion of deaths | From baseline and up to 20 years follow-up | Long time follow-up in registers. Proportion of patients. Diagnosis and date of death |
| Proportion of cardiovascular death | From baseline and up to 20 years follow-up | 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) |
| Proportion of patients affected with venous thromboembolism | From baseline and up to 20 years follow-up | 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) |
| Proportion of patients affected by MACE (Myocardial infarction, stroke or cardiovascular death) | From baseline and up to 20 years follow-up | 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). |
| Co-peptin | At baseline and follow-up at 12 and 24 months from baseline. | Measured at baseline in pmol/L. Blood sampling after overnight fasting. |
| Blood glucose | At baseline and follow-up at 12 and 24 months from baseline. | Fasting blood glucose from venous blood sampling in mmol/L |
| BMI | At baseline and follow-up at 12 and 24 months from baseline. | BMI (weight and height will be combined to report BMI in kg/m\^2) |
| Waist hip ratio (WHR) | At baseline and follow-up at 12 and 24 months from baseline. | WHR will be calculated by the ratio between waist in cm and and hip in cm |
| Blood pressure | At baseline and follow-up at 12 and 24 months from baseline. | Measured (mmHg), sitting at right arm after 10 minutes of resting with both feet on the floor. |
Countries
Sweden
Contacts
STUDY_CHAIRMiriam Pikkemaat, PhD
Lund University/ Region Skane
Outcome results
None listed