Psychotic Disorders
Conditions
Keywords
Psychotic disorders, Quality of life, Cost-effectiveness, Cardiometabolic risk factors, Cardiovascular disease prevention, Metabolic syndrome, Pragmatic clinical trial, Integrated health care, Multicomponent intervention, Behavior change intervention
Brief summary
Background Cardiometabolic conditions-including cardiovascular disease, type 2 diabetes, and obesity-are highly prevalent among individuals with psychotic disorders. These conditions contribute substantially to reduced life expectancy, diminished quality of life, and increased societal and economic burdens. Thus, effective, individualized interventions are urgently needed. Outpatient psychiatric clinics offer an ideal setting for such efforts owing to regular patient contact and access to multidisciplinary care. We have developed a comprehensive, clinically integrated trial aimed at improving cardiometabolic health, promoting healthier lifestyles, and enhancing quality of life for individuals with psychotic disorders receiving care in the Greater Gothenburg region. Methods LAGOM is a multicenter, naturalistic, quasi-experimental case-control trial conducted across six geographically separate outpatient psychosis clinics within the Department of Psychotic Disorders at Sahlgrenska University Hospital, a multi-site university hospital in the Greater Gothenburg region. A total of 650 adults with psychotic disorders will be recruited from these clinics. Two clinics will implement the LAGOM intervention, whereas four will serve as control sites delivering usual care. The intervention is embedded within routine psychiatric care and grounded in behavioral science. It includes comprehensive cardiometabolic risk assessments, two visual motivational tools (QRISK3 and a body composition analyzer), personalized follow-up plans, risk-oriented referrals to primary care, and structured education for patients, relatives, and staff. The intervention is designed to be scalable, sustainable, and tailored to individual patient needs. Discussion If proven superior to usual care, this pragmatic, multicomponent intervention-delivered within routine psychiatric care-could improve cardiometabolic health and quality of life for individuals with psychotic disorders. Embedding the intervention within existing clinical structures enhances its scalability and feasibility and, if effective, could serve as a model for wider implementation.
Interventions
OTHERIntervention
The intervention group follows a structured flowchart for annual health check-ups, focusing on assessing the cardiometabolic profile, considering sex and ethnicity. This assessment includes tracking changes in cardiometabolic parameters, alongside overall cardiometabolic risk using SCORE2 and if the criteria for metabolic syndrome are met. Lifestyle habits are evaluated based on health status, illness, and benefits of quitting unhealthy behaviors. Education sessions educate participants and families on the link between psychotic disorders, lifestyle choices, and cardiometabolic health. Gradual lifestyle changes are tailored to individual needs, addressing stress and cognitive challenges, and follow national health guidelines with personalized advice and motivational tools. Regular follow-ups assess progress, while motivational tools "body composition analyzer and QRISK3" enhance engagement. Contact with internal and external resources is based on the assessment and motivational work.
Sponsors
Vastra Gotaland Region
The Swedish Society of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a longitudinal, multicenter, naturalistic, multicomponent, parallel-group, quasi-experimental cluster-based trial with a superiority framework. The trial uses a case-control clinical design with a 1:3 allocation ratio, assigning one participant at the intervention clinics for every three at the control clinics. Clusters are defined at the level of outpatient clinics, with two intervention clinics and four control clinics.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥18 years of age meeting the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29) 2. Ability to provide informed consent
Exclusion criteria
1. Having an electrical medical implant such as a pacemaker or other mechanical implants 2. Pregnancy 3. Deemed unsuitable by the investigator: A person may be deemed unsuitable for participation if circumstances prevent safe or reliable participation in the trial. Examples include inability or unwillingness to maintain contact with the clinic (e.g., absence of a stable address or telephone number), planned relocation or transfer to another treatment facility, municipality, or country during the trial period, mobility limitations or other practical barriers preventing attendance at clinic visits, or administrative restrictions preventing appropriate documentation in medical records or trial databases (e.g., protected or anonymous identity status). Such decisions are made on an individual basis in consultation with the clinical team (case manager (CM), treating psychiatrist, and site principal investigator (PI)) to ensure patient safety and trial integrity. 4. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period). 5. Currently under compulsory care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm | At 12 months from baseline. | Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2). |
| Change in waist-hip ratio | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR). |
| Change in systolic blood pressure | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in systolic blood pressure (SBP) (mm Hg). |
| Change in diastolic blood pressure | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in diastolic blood pressure (DBP) mm Hg. |
| Change in plasma glucose | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in plasma glucose (mmol/L). |
| Change in total cholesterol/HDL-C ratio | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio). |
| Change in triacylglycerol/high density lipoprotein-cholesterol ratio | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio). |
| Change in cardiovascular disease (CVD) events | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events. |
| Change in incident rate of type 2 diabetes mellitus events | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoint: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events. |
| Change in quality of life | At 12 months from baseline. | To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in the EQ-5D-5L score (quality of life)\*. \*Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). |
| Change in high-sensitivity C-reactive protein | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in hs-CRP (mg/L). |
| Change in HbA1c | At 12 months from baseline. | To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in HbA1c (mmol/mol). |
| Descriptive cost analysis | At 12 months from baseline. | To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR. |
| Change in quality-Adjusted Life Years | At 12 months from baseline. | To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups. |
| Incremental cost-effectiveness ratio based on CVD | At 12 months from baseline. | To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained. |
| Incremental cost-effectiveness ratio based on type 2 diabetes mellitus | At 12 months from baseline. | To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. |
| Incremental cost-effectiveness ratio based on QALYs | At 12 months from baseline. | To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained. |
| Change in alcohol consumption | At 12 months from baseline. | To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)\*, scale 0-12). \*The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders. |
| Change in tobacco smoking | At 12 months from baseline. | To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in tobacco smoking\* per week. \*The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use). |
| Change in dietary habits | At 12 months from baseline. | To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in dietary habits (dietary index)\* (scale 0-12). \*The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice. |
| Change in physical activity | At 12 months from baseline. | To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in physical activity\* (number of minutes per day). \*The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time). |
Countries
Sweden
Contacts
CONTACTHemen Najar, M.D., Ph.D.
Outcome results
None listed