HEAlth Dialogues for Patients With Mental Illness in Primary Care
- Conditions
- DepressionDeathMental IllnessDiabetesMyocardial DiseaseStrokeStressFatigueSleep Disorder
- Interventions
- Behavioral: health dialogue
- Registration Number
- NCT05181254
- Lead Sponsor
- Region Skane
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- patients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems
- Dementia, not speaking, writing or understanding spoken the Swedish language.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Health dialogue 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Referral physiotherapist At 12 and 24 months from baseline Proportion of patients who have received referral to physiotherapist
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
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
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)
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)
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 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 deaths From baseline and up to 20 years follow-up Long time follow-up in registers. Proportion of patients. Diagnosis and date of 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 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.
Referral dietitian At 12 and 24 months from baseline Proportion of patients who have received referral to dietitian
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)
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
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
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)
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)
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).
Trial Locations
- Locations (1)
Peter Nymberg
🇸🇪Helsingborg, Region Skane, Sweden