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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Gelderland
-
Ermelo, Gelderland, Holanda, 3853LC
- Veldwijk
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Severe Mentally Ill patients,
- living in Sheltered Housing facilities
Exclusion Criteria:
- Incapacitated patients,
- without informed consent from their legal representative
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Tratamento como de costume
|
|
|
Experimental: Lifestyle treatment
|
Lifestyle treatment
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Metabolic Health: Waist circumference
Prazo: 12 months
|
measured halfway between the iliac crest and lowest rib in standing position
|
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Metabolic Health: weight
Prazo: 12 months
|
weight measured to the nearest 0.1kg
|
12 months
|
|
Metabolic Health: blood pressure
Prazo: 12 months
|
measured systolic and diastolic blood pressure (mmHg)
|
12 months
|
|
Metabolic Health:Lipids
Prazo: 12 months
|
values in blood sample
|
12 months
|
|
Metabolic Health:Fasting glucose
Prazo: 12 months
|
values in blood sample
|
12 months
|
|
Metabolic health: HbA1c
Prazo: 12 months
|
values in blood sample
|
12 months
|
|
Sedentary behaviour & physical activity
Prazo: 12 months
|
measured 5 consecutive days with an accelerometer (ActiGraph GT3X+
|
12 months
|
|
Quality of Life EuroQol 5D
Prazo: 12 months
|
measured by the EuroQol 5D (EQ-5D)
|
12 months
|
|
Quality of Life WHOQoL
Prazo: 12 months
|
measured by the WHOQoL-Bref
|
12 months
|
|
Psychopathology BPRS-E
Prazo: 12 months
|
Psychopathology / illness severity measured by the BPRS-E
|
12 months
|
|
Implementation fidelity
Prazo: At follow-up (12 months)
|
A proxy for implementation fidelity using the 'descriptive norm' item of the Measurement Instrument for Determinants of Innovations
|
At follow-up (12 months)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Peter N van Harten, Prof. Dr., GGZ Centraal
Publicações e links úteis
Publicações Gerais
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- Delespaul PH; de consensusgroep EPA. [Consensus regarding the definition of persons with severe mental illness and the number of such persons in the Netherlands]. Tijdschr Psychiatr. 2013;55(6):427-38. Dutch.
- Dingemans PM, Linszen DH, Lenior ME, Smeets RM. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology (Berl). 1995 Dec;122(3):263-7. doi: 10.1007/BF02246547.
- Docx L, Sabbe BG, Koning J, Mentzel TQ, van Harten PN, Morrens M. [Instrumental registration of psychomotor symptoms in schizophrenia: has the time come to use the technique in clinical practice?]. Tijdschr Psychiatr. 2015;57(2):148-53. Dutch.
- Farnam CR, Zipple AM, Tyrrell W, Chittinanda P. Health status risk factors of people with severe and persistent mental illness. J Psychosoc Nurs Ment Health Serv. 1999 Jun;37(6):16-21. doi: 10.3928/0279-3695-19990601-15.
- Gerlach J, Korsgaard S, Clemmesen P, Lauersen AM, Magelund G, Noring U, Povlsen UJ, Bech P, Casey DE. The St. Hans Rating Scale for extrapyramidal syndromes: reliability and validity. Acta Psychiatr Scand. 1993 Apr;87(4):244-52. doi: 10.1111/j.1600-0447.1993.tb03366.x.
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- Killaspy H, White S, Wright C, Taylor TL, Turton P, Kallert T, Schuster M, Cervilla JA, Brangier P, Raboch J, Kalisova L, Onchev G, Alexiev S, Mezzina R, Ridente P, Wiersma D, Visser E, Kiejna A, Piotrowski P, Ploumpidis D, Gonidakis F, Caldas-de-Almeida JM, Cardoso G, King M. Quality of longer term mental health facilities in Europe: validation of the quality indicator for rehabilitative care against service users' views. PLoS One. 2012;7(6):e38070. doi: 10.1371/journal.pone.0038070. Epub 2012 Jun 4.
- Kruisdijk F, Deenik J, Tenback D, Tak E, Beekman AJ, van Harten P, Hopman-Rock M, Hendriksen I. Accelerometer-measured sedentary behaviour and physical activity of inpatients with severe mental illness. Psychiatry Res. 2017 Aug;254:67-74. doi: 10.1016/j.psychres.2017.04.035. Epub 2017 Apr 22.
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- Ozemek C, Kirschner MM, Wilkerson BS, Byun W, Kaminsky LA. Intermonitor reliability of the GT3X+ accelerometer at hip, wrist and ankle sites during activities of daily living. Physiol Meas. 2014 Feb;35(2):129-38. doi: 10.1088/0967-3334/35/2/129. Epub 2014 Jan 7.
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- Tenback DE, van Kessel F, Jessurun J, Pijl YJ, Heerdink ER, van Harten PN. [Risk factors for inactivity in patients in long-term care with severe mental illness]. Tijdschr Psychiatr. 2013;55(2):83-91. Dutch.
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- NL61552.075.17
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