長期臨床試験を通じて重度の精神疾患を持つ人々の心臓と代謝の健康を改善 (LAGOM)

ヨーテボリにおける「通常のケア」モデルには、精神病性障害を持つ個人に対する年次健康診断が含まれています。 患者は、血液検査、血圧測定、体重測定などの評価のために、各60分の診察を2回受け、その結果は標準的な基準またはSCORE2などのリスクアルゴリズムを用いて評価されます。 医師は、一次医療への紹介を提案したり、食事、運動、または薬物使用の調整を含む生活習慣の変更を勧めることがあります。 特定された問題は、簡単なアドバイスや、禁煙支援、食事指導、またはグループ活動のための健康増進担当者への紹介を促す可能性があります。

36 ± 6か月の臨床試験では、ケアを変更することなく、4つの外来クリニックでデータ収集を標準化しています。 適格な患者は同意書に署名し、ある年次健康診断で除外基準を満たすが次の診断では満たさない場合、再スクリーニングが許可されます。 非参加者は通常のケアを継続します。

介入グループは、性別と民族を考慮した心臓代謝プロファイルの評価に焦点を当て、年次健康診断の構造化されたフローチャートに従います。 この評価には、SCORE2 を使用した心血管代謝パラメータの変化の追跡と、メタボリックシンドロームの基準が満たされているかどうかの全体的な心血管代謝リスクの追跡が含まれます。

生活習慣は、健康状態、病気、不健康な行動をやめることによるメリットに基づいて評価されます。 教育セッションでは、精神障害、ライフスタイルの選択、心臓代謝の健康との関連性について参加者と家族を教育します。

段階的なライフスタイルの変更は個人のニーズに合わせて調整され、ストレスや認知の問題に対処し、個別のアドバイスやモチベーションを高めるツールを備えた国の健康ガイドラインに従います。 定期的なフォローアップで進捗状況を評価し、モチベーションを高めるツール「体組成計と QRISK3」でエンゲージメントを高めます。 社内および社外のリソースとの連絡は、評価と動機付けに基づいて行われます。

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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).

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.

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.

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.

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).

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).

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).