Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving a weight loss of ≥5% of initial body weight.
研究概览
简要总结
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
详细描述
Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with high mortality rates and cardiovascular disease. Obesity and dysmetabolism caused by antipsychotic medication comprise modifiable risk factors, which remain undertreated.
The investigators will address the gaps in cardiometabolic care of SMI patients by examining the effectiveness of a pragmatic metabolic care clinic for patients with SMI. Moreover, the investigators will include qualitative investigation of patients' perspectives in relation to acceptability, satisfaction with care, and motivation for health behaviour change.
A total of 84 patients between 18-45 years with diagnoses of schizophrenia spectrum disorders or bipolar disorder will be recruited from inpatient and outpatient clinics in the Mental Health Services of the Capital Region of Denmark. Eligible patients are antipsychotics-treated and present with a 5% weight increase / 5 cm waistline increase since initiation of antipsychotic therapy or body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 and concomitant prediabetes, diabetes, hypertension, sleep apnoea and/or dyslipidaemia.
Patients will be enrolled in an open-label randomized controlled parallel-group trial with an allocation-ratio of 1:1 to a pragmatic, specialized metabolic clinic with measurement-based care and evidence-based best-practice treatment or standard care. The primary outcome is the proportion of patients in the intervention group achieving a weight loss ≥5% of initial body weight vs the standard care group at 12 months. Secondary and exploratory outcomes include changes in other cardiovascular risk factors, quality of life, personal recovery and cognitive measures. Finally, qualitative interviews will explore patient experience and contextual factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)
- •Medical treatment with antipsychotics
- •Age 18-45 years
- •Legally competent
- •Able to give informed consent
- •and either:
- •- Body mass index (BMI) ≥30 kg/m
- •BMI ≥27 kg/m2 and at least one of the following:
- •Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office / 24-hour, non-invasive ambulatory blood pressure ≥140/90 mmHg within the previous 6 months
- •Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol/l), elevated triglycerides (≥1.7 mmol/l) or low high-density lipoprotein cholesterol (≥1.2 mmol/l in women and ≥1.0 mmol/l in men) within the previous 6 months
- •Sleep apnoea (ICD-10 DG473).
- •Prediabetes or diabetes defined as HbA1c ≥42 mmol/mol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.
- •- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.
排除标准
- •Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.
- •Unstable psychiatric disorder as judged by the research team.
- •Severe current drug or alcohol misuse as judged by the research team.
- •Acute suicidal risk.
研究组 & 干预措施
Treatment in the Meta Care Clinic
The patients who after randomization are allocated to the treatment arm will receive 12 months of treatment in a pragmatic metabolic clinic. Patients will receive measurements/monitoring at least 3 times during the study period: Upon enrolment, after 6 months and after 12 months.
干预措施: Treatment in the Meta Care Clinic (Other)
Standard care with general practitioner and/or outpatient clinics
The patients who after randomization are allocated for standard care will continue with their current psychiatric out-patient clinic and/or contact with their general practitioner. Patients will receive measurements/monitoring upon enrolment and after 12 months.
干预措施: Standard care with general practitioner and/or outpatient clinics (Other)
结局指标
主要结局
Proportion of patients achieving a weight loss of ≥5% of initial body weight.
时间窗: 12 months
Proportion of patients in the intervention group achieving a weight loss of ≥5% of initial body weight vs the standard care group at 12 months.
次要结局
- Low-density lipoprotein cholesterol(12 months)
- Total cholesterol(12 months)
- The metabolic composite score(12 months)
- Cardiovascular risk factors(12 months)
- Proportion of patients achieving a weight loss of ≥10% of initial body weight.(12 months)
- Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol(12 months)
- Body weight(12 months)
- Waist circumference(12 months)
- Body mass index(12 months)
- Glucose(12 months)
- Insulin(12 months)
- The homeostatic Model Assessment for Insulin Resistance(12 months)
- High-density lipoprotein cholesterol(12 months)
- Very Low-density lipoprotein cholesterol(12 months)
- Triglycerides(12 months)
- Heart rate(12 months)
- Blood pressure(12 months)
- Hemoglobin A1c(12 months)
研究者
Bjorn H. Ebdrup
MD, consultant, PhD and clinical professor in psychiatry Bjørn Hylsebeck Ebdrup
University of Copenhagen