Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 10
- 主要终点
- Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Ability to provide informed consent
排除标准
- •Having an electrical medical implant such as a pacemaker or other mechanical implants
- •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.
- •Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
- •Currently under compulsory care.
研究组 & 干预措施
Control clinics (usual care)
The "usual care" model in Gothenburg includes annual health checks for individuals with psychotic disorders. Patients attend two 60-minute visits for assessments such as blood tests, blood pressure, and weight checks, with results evaluated using standard benchmarks or risk algorithms like SCORE2. Physicians may suggest referrals to primary care or recommend lifestyle changes, including diet, exercise, or substance use adjustments. Identified issues may prompt simple advice or referrals to health promoters for support with smoking cessation, dietary guidance, or group activities.
The 36 ± 6-month clinical trial standardizes data collection at four outpatient clinics without altering care. Eligible patients sign consent, with rescreening allowed if a patient meets the exclusion criteria at one annual check but not at the next. Non-participants continue with regular care.
Intervention Clinics
The annual health checks for the intervention group follow the same structure of two visits as in routine care as usual, with the primary difference being the content of the visits.
干预措施: Intervention (Other)
结局指标
主要结局
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
时间窗: 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.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
时间窗: At 24 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.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
时间窗: At 36 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.
次要结局
- Change in body mass index(At 12 months from baseline.)
- Change in body mass index(At 24 months from baseline.)
- Change in body mass index(At 36 months from baseline.)
- Change in waist-hip ratio(At 12 months from baseline.)
- Change in waist-hip ratio(At 24 months from baseline.)
- Change in waist-hip ratio(At 36 months from baseline.)
- Change in systolic blood pressure(At 12 months from baseline.)
- Change in systolic blood pressure(At 24 months from baseline.)
- Change in systolic blood pressure(At 36 months from baseline.)
- Change in diastolic blood pressure(At 12 months from baseline.)
- Change in diastolic blood pressure(At 24 months from baseline.)
- Change in diastolic blood pressure(At 36 months from baseline.)
- Change in plasma glucose(At 12 months from baseline.)
- Change in plasma glucose(At 24 months from baseline.)
- Change in plasma glucose(At 36 months from baseline.)
- Change in total cholesterol/HDL-C ratio(At 12 months from baseline.)
- Change in total cholesterol/HDL-C ratio(At 24 months from baseline.)
- Change in total cholesterol/HDL-C ratio(At 36 months from baseline.)
- Change in triacylglycerol/high density lipoprotein-cholesterol ratio(At 12 months from baseline.)
- Change in triacylglycerol/high density lipoprotein-cholesterol ratio(At 24 months from baseline.)
- Change in triacylglycerol/high density lipoprotein-cholesterol ratio(At 36 months from baseline.)
- Change in cardiovascular disease (CVD) events(At 12 months from baseline.)
- Change in cardiovascular disease (CVD) events(At 24 months from baseline.)
- Change in cardiovascular disease (CVD) events(At 36 months from baseline.)
- Change in incident rate of type 2 diabetes mellitus events(At 12 months from baseline.)
- Change in incident rate of type 2 diabetes mellitus events(At 24 months from baseline.)
- Change in quality of life(At 12 months from baseline.)
- Change in quality of life(At 24 months from baseline.)
- Change in quality of life(At 36 months from baseline.)
- Change in high-sensitivity C-reactive protein(At 12 months from baseline.)
- Change in high-sensitivity C-reactive protein(At 24 months from baseline.)
- Change in high-sensitivity C-reactive protein(At 36 months from baseline.)
- Change in HbA1c(At 12 months from baseline.)
- Change in HbA1c(At 24 months from baseline.)
- Change in HbA1c(At 36 months from baseline.)
- Descriptive cost analysis(At 12 months from baseline.)
- Descriptive cost analysis(At 24 months from baseline.)
- Descriptive cost analysis(At 36 months from baseline.)
- Change in quality-Adjusted Life Years(At 12 months from baseline.)
- Change in quality-Adjusted Life Years(At 24 months from baseline.)
- Change in quality-Adjusted Life Years(At 36 months from baseline.)
- Incremental cost-effectiveness ratio based on CVD(At 12 months from baseline.)
- Incremental cost-effectiveness ratio based on CVD(At 24 months from baseline.)
- Incremental cost-effectiveness ratio based on CVD(At 36 months from baseline.)
- Incremental cost-effectiveness ratio based on type 2 diabetes mellitus(At 12 months from baseline.)
- Incremental cost-effectiveness ratio based on type 2 diabetes mellitus(At 24 months from baseline.)
- Incremental cost-effectiveness ratio based on type 2 diabetes mellitus(At 36 months from baseline.)
- Incremental cost-effectiveness ratio based on QALYs(At 12 months from baseline.)
- Incremental cost-effectiveness ratio based on QALYs(At 24 months from baseline.)
- Incremental cost-effectiveness ratio based on QALYs(At 36 months from baseline.)
- Change in alcohol consumption(At 12 months from baseline.)
- Change in alcohol consumption(At 24 months from baseline.)
- Change in alcohol consumption(At 36 months from baseline.)
- Change in tobacco smoking(At 12 months from baseline.)
- Change in tobacco smoking(At 24 months from baseline.)
- Change in tobacco smoking(At 36 months from baseline.)
- Change in dietary habits(At 12 months from baseline.)
- Change in dietary habits(At 24 months from baseline.)
- Change in dietary habits(At 36 months from baseline.)
- Change in physical activity(At 12 months from baseline.)
- Change in physical activity(At 24 months from baseline.)
- Change in physical activity(At 36 months from baseline.)
- Change in incident rate of type 2 diabetes mellitus events(At 36 months from baseline.)