Multidisciplinary Lifestyle-enhancing Treatment for People With Severe Mental Illness in Sheltered Housing Facilities
Multidisciplinary Lifestyle-enhancing Treatment for Long-term Severe Mentally Ill Inpatients: Sheltered Housing
Introduction and rationale:
Unhealthy eating habits and lack of physical activity are risk factors for many diseases (including metabolic syndrome) and contribute to a shortened lifespan of 15-30 years in people with severe mental illness (SMI). Literature, mainly including short-term hospitalized or outpatients, show strong positive effects of activation on both physical and mental health. However, studies in long-term care are limited. In recent years, implementation of a lifestyle enhancing treatment intervention in clinical settings in "GGz Centraal" has demonstrated to be effective. The question is whether this kind of lifestyle intervention in sheltered housing is applicable and effective.
Objectives:
This research aims to develop an appropriate lifestyle intervention for patients living in sheltered housing services of GGz Centraal, based on input of patients and directly involved. Does applying this lifestyle treatment result in a positive effect in health and quality of life of patients and what is the influence of contextual factors, personal- and disease characteristics?
Study design:
In this intervention study, we use an experimental design. Municipal locations are paired based on the number of participants to generate equal cluster sizes. These paired clusters are randomly allocated to the control or intervention arm by means of a random number generator by an independent person (not involved in this project). At the start of the lifestyle treatment patients in the experimental and control group are invited to participate in the baseline screening. After twelve months, following a post-test on all outcome measures.
Treatment intervention:
The intervention in this study consists of formulating a lifestyle intervention, by patients and directly involved, aimed at enhancing a more active and healthier lifestyle . After formulation of the plan (based on psycho education, nutrition and physical activity), it wil be executed for a twelve month period.
Hypothesis:
Hypotheses is that lifestyle enhancing treatment is associated with improved metabolic health, quality of life and reduced use of medication. Furthermore we expect that movement disorders and disease severity will be negative related in becoming more active.
研究概览
详细说明
Sample size calculation:
To calculate the sample size we use the effect size on decrease in waist circumference in the previous intervention study (d =0.51) and the same analysis (multiple regression with correction for baseline value's on age, diagnosis and disease severity). To be able to detect the same effect in the current study with a minimum 80% power as a benchmark for a fair test and a significant level of 95% (α = 0.05), a minimum sample of 124 people is required (2 groups of 62). Taking into account a response rate of 73% from the first measurement a sample size of 168 patients is required.
Analyses:
We use multilevel regression to analyze the intervention effect. Possible clustering of data within the residential locations (and thus care teams) is taken into account by using a two-level structure with the first level residential location and the patients as the second. The intervention variable is set as an independent variable against difference scores of outcome variables (T2 minus T1) and corrected for the baseline value of the outcome to prevent regression to the centre. As we are unable to randomize patients individually in the current configuration on personal and disease characteristics (gender, age, diagnosis, disease severity at the start of intervention), these factors will be corrected for in the analyses if they differ significantly(p<0.05) between intervention and control group, analysed using independent t-tests and chi-squared tests. Characteristics that differ significantly will be included as covariates in the analysis described above. Multicollinearity will be checked with correlation coefficients and collinearity statistics (tolerance and Variance Inflation Factors (VIF) values).
Missing data:
Patients who are hospitalized for more than two months will be excluded from analyses.
If baseline or follow-up data are missing for two or more measures on physical or psychiatric health, patients are excluded from the analysis as insufficient difference scores can be calculated. Patients lacking difference scores on one outcome variable, are excluded from the analysis of that particular variable.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Gelderland
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Ermelo、Gelderland、荷兰、3853LC
- Veldwijk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Severe Mentally Ill patients,
- living in Sheltered Housing facilities
Exclusion Criteria:
- Incapacitated patients,
- without informed consent from their legal representative
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：照常治疗
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实验性的：Lifestyle treatment
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Lifestyle treatment
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Metabolic Health: Waist circumference
大体时间：12 months
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measured halfway between the iliac crest and lowest rib in standing position
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Metabolic Health: weight
大体时间：12 months
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weight measured to the nearest 0.1kg
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12 months
|
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Metabolic Health: blood pressure
大体时间：12 months
|
measured systolic and diastolic blood pressure (mmHg)
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12 months
|
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Metabolic Health:Lipids
大体时间：12 months
|
values in blood sample
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12 months
|
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Metabolic Health:Fasting glucose
大体时间：12 months
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values in blood sample
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12 months
|
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Metabolic health: HbA1c
大体时间：12 months
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values in blood sample
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12 months
|
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Sedentary behaviour & physical activity
大体时间：12 months
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measured 5 consecutive days with an accelerometer (ActiGraph GT3X+
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12 months
|
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Quality of Life EuroQol 5D
大体时间：12 months
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measured by the EuroQol 5D (EQ-5D)
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12 months
|
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Quality of Life WHOQoL
大体时间：12 months
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measured by the WHOQoL-Bref
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12 months
|
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Psychopathology BPRS-E
大体时间：12 months
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Psychopathology / illness severity measured by the BPRS-E
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12 months
|
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Implementation fidelity
大体时间：At follow-up (12 months)
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A proxy for implementation fidelity using the 'descriptive norm' item of the Measurement Instrument for Determinants of Innovations
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At follow-up (12 months)
|
合作者和调查者
赞助
调查人员
- 研究主任：Peter N van Harten, Prof. Dr.、GGZ Centraal
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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Lifestyle treatment的临床试验
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Institute of Liver and Biliary Sciences, India招聘中
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险
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University of Alabama at BirminghamNational Cancer Institute (NCI)完全的
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中