MOBility Disorders Assessment in Patients With Mild COGnitive Disorders (COG-MOB)
Multimodal and Longitudinal Assessment of MOBility Disorders in Patients With Mild COGnitive Disorders
Mild cognitive impairment (MCI) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. Sixteen percent of community-dwelling older people (over 65 years) live with MCI. They are both cognitively and physically vulnerable. From a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. From a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with MCI. Falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. In the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with MCI.
The research goals of this project are 1) to identify specific predictors for falls in clinic attendees with MCI in preparation for a definitive, fully powered study across France, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in MCs, whatever its setting and location.
We aim to prospectively follow-up people diagnosed with MCI and aged above 65 years old in four MCs in France (three in the North (one community-based MC), and one in the Centre) for one year.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Yaohua CHEN, MD
- Número de telefone: 0320445962
- E-mail: Yaohua.chen@chru-lille.fr
Locais de estudo
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Lille, França, 59037
- Recrutamento
- Les Bateliers Chu Lille
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Lille, França
- Recrutamento
- Hop Salengro - Hopital B
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patient being diagnosed with MCI, according to the 2011 criteria
- Able to walk 4 meters with or without technical assistance
- Comprehension of French language allowing the realization of the neuropsychological assessment
Exclusion Criteria:
- Severe visual or hearing impairment that does not allow the assessment
- Severe pathology that makes follow-up impossible
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security insurance, refusal to sign consent form
- Under legal protection (guardianship, curatorship, safeguard of justice)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Existence of at least one fall
Prazo: 12 months
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The primary objective is to identify factors predictive of having at least one fall at one year First, the relationship between each candidate risk factor (independent variables) and the presence of at least one fall at one year (binary dependent variable) will be studied by bivariate logistic regression models.
For quantitative candidate factors, the log-linearity assumption of the logistic regression model will be tested using cubic spline functions, which models the non-linear effect.
The 10 pre-selected factors will be included in a multivariate logistic regression model, regardless of the outcome of the bi-variate analyses.
The multivariate analysis will be performed following the recommendations of Peduzzi et al on the number of variables to include in a multivariate model (10 events per estimated parameter).
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comparison between the fall schedule given and kept by the patient and / or his main caregiver and the collection of anamnestic data on the occurrence of falls
Prazo: 6 months and 12 months
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6 months and 12 months
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Patients enrollment rate
Prazo: 12 months
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Adherence and acceptability of the multimodal assessment in the memory clinic
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12 months
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Satisfaction rate of caregivers assessed by a specific questionnaire (Likert)
Prazo: 12 months
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Adherence and acceptability of the multimodal assessment in the memory clinic
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12 months
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Rate of multifallers allowing the comparison of the same variables as those used for the main objective between fallers, non-fallers and multifallers
Prazo: 12 months
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12 months
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Rate of serious falls allowing the comparison of the same variables in the subgroup of patients who had had at least one serious fall
Prazo: 12 months
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12 months
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Timeframe until conversion to major cognitive impairment according to the criteria of NIA-AA of 2011
Prazo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yaohua CHEN, MD, University Hospital, Lille
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020_55
- 2021-A00637-34 (Outro identificador: ID-RCB number, ANSM)
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