NCT05181254

HEAlth Dialogues for Patients With Mental Illness in Primary Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	health 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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2022-01-06
• Last updated: 2025-04-04

Locations

1 site across 1 country: Sweden