Evaluation of the Implementation and Effectiveness of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness (MULTI+)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 846
- 试验地点
- 2
- 主要终点
- QRISK3 score
研究概览
简要总结
People with mental illness (MI) have a reduced life expectancy compared to the general population, mostly attributable to somatic diseases caused by poor physical health. Modifiable "lifestyle factors" have been increasingly associated with the onset of somatic diseases in people with MI and refer to health behaviours such as physical activity (PA), diet, sleep and smoking behaviour. Despite the evidence demonstrating the efficacy of interventions aimed at improving lifestyle factors, there have not been many structural changes in routine clinical care for people with MI. Using a multidisciplinary, multicomponent approach, Deenik and colleagues (2019) were the first to find long-term positive effects in both mental and somatic health in a real-world inpatient setting for people with severe mental illness (SMI). They found improvements in metabolic health, psychosocial functioning and quality of life, and a reduction in the use of psychotropic medication. The authors urged to confirm and complement findings in scaled-up studies, and made several suggestions for improvement of the treatment and pragmatic research of implementation. In line with these previous recommendations the MULTI is being scaled-up into the MULTI+. This study investigates the implementation and effectiveness of a multidisciplinary lifestyle treatment for inpatients with mental illness (MULTI+).
详细描述
Study design and setting
This study is a prospective open cohort stepped wedge cluster randomized trial with continuous recruitment. This study is being conducted at the inpatient psychiatric wards, covering approximately 750 places of residency in which approximately 2000 patients are treated annually, from the specialist mental healthcare organisation GGz Centraal (the Netherlands). The study uses a stepped-wedge clustered design. The psychiatric wards are divided into three clusters, based on their geographical locations. These clusters gradually implement MULTI+ in semi-annual steps, such that all clusters are exposed to the MULTI+ at the end of the study. The repeated measurements are conducted on ward-level, rather than individual patient level.
Intervention
MULTI+ is a multidisciplinary, multicomponent treatment which aims to improve lifestyle factors through a holistic lifestyle approach, by focusing on 10 core components. Core components refer to essential elements and activities that are necessary to achieve desired outcomes. The core components of MULTI+ are based on previous recommendations and existing literature. The core components of MULTI+ are routine daily structure and sleep, physical activity, attention to nutrition and eating habits, smoking cessation, multidisciplinary treatment, skills training, psychoeducation, critical review of obesogenic environment and existing policies, active participation of health care professionals (HCPs), and training of HCPs. The core components are co-designed and tailored to the ward and patient population, because of the large heterogeneity in patient characteristics and varying access to facilities and staffing.
Analyses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years or older
- •Mentally ill inpatients
- •Receive care at the inpatient psychiatric wards of GGz Centraal where the MULTI+ will be implemented
排除标准
- •Limited knowledge or understanding of Dutch
- •If their psychiatric or physical condition hinders informed consent at the discretion of the relevant physician, nurses, or researcher
结局指标
主要结局
QRISK3 score
时间窗: 4 measurements semi-annually over a period of 24 months
Algorithm that estimates the probability of developing cardiovascular disease over the next 10 years by taking multiple risk factors into account.
次要结局
- Change in medication use through daily defined doses (DDD)(4 measurements semi-annually over a period of 24 months)
- Change in psychosocial functioning: Elderly(4 measurements semi-annually over a period of 24 months)
- Change in Quality of life (WHOQoL-Bref)(4 measurements semi-annually over a period of 24 months)
- Change in metabolic health: Waist circumference(4 measurements semi-annually over a period of 24 months)
- Change in metabolic Health:Lipids(4 measurements semi-annually over a period of 24 months)
- Change in metabolic Health: HDL Cholesterol(4 measurements semi-annually over a period of 24 months)
- Change in metabolic Health: Fasting glucose(4 measurements semi-annually over a period of 24 months)
- Weight Change(4 measurements semi-annually over a period of 24 months)
- Change in BMI(4 measurements semi-annually over a period of 24 months)
- Change in psychosocial functioning: Adolescents(4 measurements semi-annually over a period of 24 months)
- Change in amount of adverse events(24 months)
- Change in motivation for behavioural regulation for healthy diet(4 measurements semi-annually over a period of 24 months)
- Change in psychosocial functioning: Adults(4 measurements semi-annually over a period of 24 months)
- Change in psychopathology (BSI)(4 measurements semi-annually over a period of 24 months)
- Change in metabolic health: Systolic and diastolic blood pressure(4 measurements semi-annually over a period of 24 months)
- Change in metabolic Health: triglycerides(4 measurements semi-annually over a period of 24 months)
- Change in diet(4 measurements semi-annually over a period of 24 months)
- Change in dietary habits(4 measurements semi-annually over a period of 24 months)
- Change in physical activity (PA): PaVs(4 measurements semi-annually over a period of 24 months)
- Change in sleep (SCOPA-sleep)(4 measurements semi-annually over a period of 24 months)
- Change in meaning in life (MHC-SF)(4 measurements semi-annually over a period of 24 months)
- Barriers and facilitators of the implementation of the MULTI+ (MIDI)(4 measurements semi-annually over a period of 24 months)
- Change in substance use(4 measurements semi-annually over a period of 24 months)
- Change in physical activity (PA): SIMPAQ(4 measurements semi-annually over a period of 24 months)
- Change in Quality of life (EQ-5D)(4 measurements semi-annually over a period of 24 months)
- Change in motivation for behavioural regulation for physical activity(4 measurements semi-annually over a period of 24 months)
- Health Technology Assessment (HTA)(24 months)