HEAlth Dialogues for Patients With Mental Illness in Primary Care

Stroke Clinical Trial

— HEAD-MIP  

Official title:

HEAlth Dialogues for Patients With Mental Illness in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181254
• Other study ID #: 2021-10-28
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Veronica Milos Nymberg, PhD
• Phone: +46 (0)733565679
• Email: veronica.milos_nymberg[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Sweden	Peter Nymberg	Helsingborg	Region Skane

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (22)

Agorastos A, Sommer A, Heinig A, Wiedemann K, Demiralay C. Vasopressin Surrogate Marker Copeptin as a Potential Novel Endocrine Biomarker for Antidepressant Treatment Response in Major Depression: A Pilot Study. Front Psychiatry. 2020 May 20;11:453. doi: 10.3389/fpsyt.2020.00453. eCollection 2020. — View Citation

Bonow RO. Primary prevention of cardiovascular disease: a call to action. Circulation. 2002 Dec 17;106(25):3140-1. doi: 10.1161/01.cir.0000048067.86569.e1. No abstract available. — View Citation

Enhorning S, Christensson A, Melander O. Plasma copeptin as a predictor of kidney disease. Nephrol Dial Transplant. 2019 Jan 1;34(1):74-82. doi: 10.1093/ndt/gfy017. — View Citation

Enhorning S, Wang TJ, Nilsson PM, Almgren P, Hedblad B, Berglund G, Struck J, Morgenthaler NG, Bergmann A, Lindholm E, Groop L, Lyssenko V, Orho-Melander M, Newton-Cheh C, Melander O. Plasma copeptin and the risk of diabetes mellitus. Circulation. 2010 May 18;121(19):2102-8. doi: 10.1161/CIRCULATIONAHA.109.909663. Epub 2010 May 3. — View Citation

Farnkvist L, Olofsson N, Weinehall L. Did a health dialogue matter? Self-reported cardiovascular disease and diabetes 11 years after health screening. Scand J Prim Health Care. 2008;26(3):135-9. doi: 10.1080/02813430802113029. — View Citation

Forsyth A, Deane FP, Williams P. A lifestyle intervention for primary care patients with depression and anxiety: A randomised controlled trial. Psychiatry Res. 2015 Dec 15;230(2):537-44. doi: 10.1016/j.psychres.2015.10.001. Epub 2015 Oct 3. — View Citation

Gibson M, Carek PJ, Sullivan B. Treatment of co-morbid mental illness in primary care: how to minimize weight gain, diabetes, and metabolic syndrome. Int J Psychiatry Med. 2011;41(2):127-42. doi: 10.2190/PM.41.2.c. — View Citation

Jao NC, Robinson LD, Kelly PJ, Ciecierski CC, Hitsman B. Unhealthy behavior clustering and mental health status in United States college students. J Am Coll Health. 2019 Nov-Dec;67(8):790-800. doi: 10.1080/07448481.2018.1515744. Epub 2018 Nov 28. — View Citation

Kaczmarczyk M, Spitzer C, Wingenfeld K, Wiedemann K, Kuehl LK, Schultebraucks K, Deuter CE, Otte C. No association between major depression with and without childhood adversity and the stress hormone copeptin. Eur J Psychotraumatol. 2020 Nov 2;11(1):1837511. doi: 10.1080/20008198.2020.1837511. — View Citation

Krogh J, Gotze JP, Jorgensen MB, Kristensen LO, Kistorp C, Nordentoft M. Copeptin during rest and exercise in major depression. J Affect Disord. 2013 Oct;151(1):284-90. doi: 10.1016/j.jad.2013.06.007. Epub 2013 Jul 13. — View Citation

Lingfors H, Lindstrom K, Persson LG, Bengtsson C, Lissner L. Lifestyle changes after a health dialogue. Results from the Live for Life health promotion programme. Scand J Prim Health Care. 2003 Dec;21(4):248-52. doi: 10.1080/02813430310003282. — View Citation

Lingfors H, Persson LG, Lindstrom K, Bengtsson C, Lissner L. Effects of a global health and risk assessment tool for prevention of ischemic heart disease in an individual health dialogue compared with a community health strategy only results from the Live for Life health promotion programme. Prev Med. 2009 Jan;48(1):20-4. doi: 10.1016/j.ypmed.2008.10.009. Epub 2008 Nov 1. — View Citation

Lingfors H, Persson LG. All-cause mortality among young men 24-26 years after a lifestyle health dialogue in a Swedish primary care setting: a longitudinal follow-up register study. BMJ Open. 2019 Jan 29;9(1):e022474. doi: 10.1136/bmjopen-2018-022474. — View Citation

Neeleman J, Oldehinkel AJ, Ormel J. Positive life change and remission of non-psychotic mental illness. A competing outcomes approach. J Affect Disord. 2003 Sep;76(1-3):69-78. doi: 10.1016/s0165-0327(02)00068-x. — View Citation

Persson LG, Lindstrom K, Lingfors H, Bengtsson C, Lissner L. Cardiovascular risk during early adult life. Risk markers among participants in "Live for Life" health promotion programme in Sweden. J Epidemiol Community Health. 1998 Jul;52(7):425-32. doi: 10.1136/jech.52.7.425. — View Citation

Persson LG, Lingfors H, Nilsson M, Molstad S. The possibility of lifestyle and biological risk markers to predict morbidity and mortality in a cohort of young men after 26 years follow-up. BMJ Open. 2015 May 6;5(5):e006798. doi: 10.1136/bmjopen-2014-006798. — View Citation

Pikkemaat M, Melander O, Bengtsson Bostrom K. Association between copeptin and declining glomerular filtration rate in people with newly diagnosed diabetes. The Skaraborg Diabetes Register. J Diabetes Complications. 2015 Nov-Dec;29(8):1062-5. doi: 10.1016/j.jdiacomp.2015.07.006. Epub 2015 Jul 9. — View Citation

Ronngren Y, Bjork A, Kristiansen L, Haage D, Enmarker I, Audulv A. Meeting the needs? Perceived support of a nurse-led lifestyle programme for young adults with mental illness in a primary health-care setting. Int J Ment Health Nurs. 2018 Feb;27(1):390-399. doi: 10.1111/inm.12333. Epub 2017 Apr 4. — View Citation

Siegenthaler J, Walti C, Urwyler SA, Schuetz P, Christ-Crain M. Copeptin concentrations during psychological stress: the PsyCo study. Eur J Endocrinol. 2014 Dec;171(6):737-42. doi: 10.1530/EJE-14-0405. Epub 2014 Sep 23. — View Citation

Stumbo SP, Yarborough BJH, Yarborough MT, Green CA. Perspectives on Providing And Receiving Preventive Health Care From Primary Care Providers and Their Patients With Mental Illnesses. Am J Health Promot. 2018 Nov;32(8):1730-1739. doi: 10.1177/0890117118763233. Epub 2018 Apr 15. — View Citation

Tasevska I, Enhorning S, Persson M, Nilsson PM, Melander O. Copeptin predicts coronary artery disease cardiovascular and total mortality. Heart. 2016 Jan;102(2):127-32. doi: 10.1136/heartjnl-2015-308183. Epub 2015 Dec 9. — View Citation

Wu Q, Kling JM. Depression and the Risk of Myocardial Infarction and Coronary Death: A Meta-Analysis of Prospective Cohort Studies. Medicine (Baltimore). 2016 Feb;95(6):e2815. doi: 10.1097/MD.0000000000002815. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who change their risk profile	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.	24 months from baseline
Secondary	Self reported risk change	Proportion of patients who had change between baseline and follow-up in self-reported lifestyle risk assessment	At 12 and 24 months from baseline
Secondary	Proportion of smokers and number of cigarettes per day	Proportion of patients, self-reported answers about smoking, Yes (number of cigarettes per day) no, or former	At baseline and follow-up at 12 and 24 months from baseline.
Secondary	Referral to smoking cessation	Proportion of patients who have undergone smoking cessation	At 12 and 24 months from baseline
Secondary	Time and intensity in physical activity	Proportion of patients in number of minutes self-reported in physical activity per week in different intensity	At baseline and follow-up at 12 and 24 months from baseline.
Secondary	Referral PaR-S	Proportion of patients who have received PaR-S	At 12 and 24 months from baseline
Secondary	Referral physiotherapist	Proportion of patients who have received referral to physiotherapist	At 12 and 24 months from baseline
Secondary	Alcohol consumption	Proportion of patients, self-reported number of glasses with 4 cl 40% alcohol per week	At baseline and follow-up at 12 and 24 months from baseline.
Secondary	Metabolic markers	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)	At 12 and 24 months from baseline
Secondary	Referral dietitian	Proportion of patients who have received referral to dietitian	At 12 and 24 months from baseline
Secondary	Proportion lost to follow-up	Proportion of dropouts / missed follow-ups	At 12 and 24 months from baseline
Secondary	Proportion of patients affected with type 2 diabetes	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).	From baseline and up to 20 years follow-up
Secondary	Proportion of patients affected with myocardial infarction	Long time follow-up in registers. Proportion of patients affected with myocardial infarction: Diagnosis and date of onset of myocardial infarction (MI) (I21)	From baseline and up to 20 years follow-up
Secondary	Proportion of patients affected with ischemic stroke	Long time follow-up in registers. Proportion of patients affected of ischemic stroke: Diagnosis and date of onset of ischemic stroke (I63)	From baseline and up to 20 years follow-up
Secondary	Proportion of deaths	Long time follow-up in registers. Proportion of patients. Diagnosis and date of death	From baseline and up to 20 years follow-up
Secondary	Proportion of cardiovascular death	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)	From baseline and up to 20 years follow-up
Secondary	Proportion of patients affected with venous thromboembolism	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)	From baseline and up to 20 years follow-up
Secondary	Proportion of patients affected by MACE (Myocardial infarction, stroke or cardiovascular death)	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).	From baseline and up to 20 years follow-up
Secondary	Co-peptin	Measured at baseline in pmol/L. Blood sampling after overnight fasting.	At baseline and follow-up at 12 and 24 months from baseline.
Secondary	Blood glucose	Fasting blood glucose from venous blood sampling in mmol/L	At baseline and follow-up at 12 and 24 months from baseline.
Secondary	BMI	BMI (weight and height will be combined to report BMI in kg/m^2)	At baseline and follow-up at 12 and 24 months from baseline.
Secondary	Waist hip ratio (WHR)	WHR will be calculated by the ratio between waist in cm and and hip in cm	At baseline and follow-up at 12 and 24 months from baseline.
Secondary	Blood pressure	Measured (mmHg), sitting at right arm after 10 minutes of resting with both feet on the floor.	At baseline and follow-up at 12 and 24 months from baseline.