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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Gelderland
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Ermelo、Gelderland、オランダ、3853LC
- Veldwijk
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Severe Mentally Ill patients,
- living in Sheltered Housing facilities
Exclusion Criteria:
- Incapacitated patients,
- without informed consent from their legal representative
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：通常通りの扱い
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実験的：Lifestyle treatment
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Lifestyle treatment
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Metabolic Health: Waist circumference
時間枠：12 months
|
measured halfway between the iliac crest and lowest rib in standing position
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12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Metabolic Health: weight
時間枠：12 months
|
weight measured to the nearest 0.1kg
|
12 months
|
|
Metabolic Health: blood pressure
時間枠：12 months
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measured systolic and diastolic blood pressure (mmHg)
|
12 months
|
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Metabolic Health:Lipids
時間枠：12 months
|
values in blood sample
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12 months
|
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Metabolic Health:Fasting glucose
時間枠：12 months
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values in blood sample
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12 months
|
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Metabolic health: HbA1c
時間枠：12 months
|
values in blood sample
|
12 months
|
|
Sedentary behaviour & physical activity
時間枠：12 months
|
measured 5 consecutive days with an accelerometer (ActiGraph GT3X+
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12 months
|
|
Quality of Life EuroQol 5D
時間枠：12 months
|
measured by the EuroQol 5D (EQ-5D)
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12 months
|
|
Quality of Life WHOQoL
時間枠：12 months
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measured by the WHOQoL-Bref
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12 months
|
|
Psychopathology BPRS-E
時間枠：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
時間枠：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)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Peter N van Harten, Prof. Dr.、GGZ Centraal
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Lifestyle treatmentの臨床試験
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Oxford Biomedical Technologies, Inc.積極的、募集していない
-
University of PittsburghNational Institute of Mental Health (NIMH)完了
-
Washington State UniversityNational Institute on Drug Abuse (NIDA)完了
-
Reistone Biopharma Company Limited完了
-
Universiti Sultan Zainal Abidin募集