Clinical trial NCT05181254: HEAlth Dialogues for Patients With Mental Illness in Primary Care
Official title: HEAlth Dialogues for Patients With Mental Illness in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Illness
Stress
Fatigue
Sleep Disorder
Depression
Diabetes
Myocardial Disease
Stroke
Death
Keywords: primary health care
health dialogue
long-term follow-up
mental illness
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2022-01-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who change their risk profile
timeFrame: 24 months from baseline
Secondary outcomes:
measure: Self reported risk change
timeFrame: At 12 and 24 months from baseline
measure: Proportion of smokers and number of cigarettes per day
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
measure: Referral to smoking cessation
timeFrame: At 12 and 24 months from baseline
measure: Time and intensity in physical activity
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
measure: Referral PaR-S
timeFrame: At 12 and 24 months from baseline
measure: Referral physiotherapist
timeFrame: At 12 and 24 months from baseline
measure: Alcohol consumption
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
measure: Metabolic markers
timeFrame: At 12 and 24 months from baseline
measure: Referral dietitian
timeFrame: At 12 and 24 months from baseline
measure: Proportion lost to follow-up
timeFrame: At 12 and 24 months from baseline
measure: Proportion of patients affected with type 2 diabetes
timeFrame: From baseline and up to 20 years follow-up
measure: Proportion of patients affected with myocardial infarction
timeFrame: From baseline and up to 20 years follow-up
measure: Proportion of patients affected with ischemic stroke
timeFrame: From baseline and up to 20 years follow-up
measure: Proportion of deaths
timeFrame: From baseline and up to 20 years follow-up
measure: Proportion of cardiovascular death
timeFrame: From baseline and up to 20 years follow-up
measure: Proportion of patients affected with venous thromboembolism
timeFrame: From baseline and up to 20 years follow-up
measure: Proportion of patients affected by MACE (Myocardial infarction, stroke or cardiovascular death)
timeFrame: From baseline and up to 20 years follow-up
measure: Co-peptin
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
measure: Blood glucose
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
measure: BMI
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
measure: Waist hip ratio (WHR)
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
measure: Blood pressure
timeFrame: At baseline and follow-up at 12 and 24 months from baseline.
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Peter Nymberg
state: Region Skane
Study officials:
affiliation: Lund University/ Region Skane
name: Miriam Pikkemaat, PhD
role: STUDY_CHAIR
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