HEAlth Dialogues for Patients With Mental Illness in Primary Care (HEAD-MIP)

Region Skane

Status: Enrolling

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

Treatments: Behavioral: health dialogue

Study type: Interventional

Funder types: Other

Identifiers

NCT05181254

2021-10-28

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Health dialogue

Experimental group

Description:

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

Treatment:

Behavioral: health dialogue