Multimodal and Longitudinal Assessment of MOBility Disorders in Patients With Mild COGnitive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 417
- 试验地点
- 3
- 主要终点
- Existence of at least one fall
研究概览
简要总结
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.
详细描述
We will identify predictors of at least one fall; of more than two falls, and of serious falls (e.g. with injuries).
Our hypotheses are that: 1) A combination of variables will predict falls, but the most important will be gait speed, the double task test and orthostatic hypotension; 2) A specific pattern of risks will exist in different subgroups. For example, in the subgroup of cerebral vascular lesions, executive functions could be the most preponderant risk factors; whereas in the absence of any lesions, the type of MCI could be the most preponderant risk factor; 3) There might be other undiscovered causes of falls, such as cardiac arrhythmia or epileptic seizures; 4) We might show some unexpected risk factors for falls such as hearing impairment and loneliness, leading to a more robust prevention strategy; 5) With the incorporation of relevant predictors, we could propose a more efficient and specific decision tree for fall risk in people with MCI.
Participants People will be recruited from the electronic medical record of MCs in three sites in France, Lille, Saint Quentin, and Tours. Lille and Tours are tertiary MCs, whereas Saint Quentin is a community-based MC. For this pilot project, we aim to recruit 417 people over two years.
The inclusion criteria are people diagnosed with MCI1, aged over 65 years and capable of walking at least 4 meters with or without aid. They are not necessarily newly diagnosed in the MC. But if they have already been followed up with in the MC, their last diagnosis should remain MCI.
The exclusion criteria are few: as any medical or psychiatric condition that precludes undertaking the study activities, and absence of informed consent from participants or their proxies. Because the final objective is to implement a feasible plan in MCs, we aim to record data as close as possible to "real world data".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Existence of at least one fall
时间窗: 12 months
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).
次要结局
- 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(6 months and 12 months)
- Patients enrollment rate(12 months)
- Satisfaction rate of caregivers assessed by a specific questionnaire (Likert)(12 months)
- Rate of multifallers allowing the comparison of the same variables as those used for the main objective between fallers, non-fallers and multifallers(12 months)
- Rate of serious falls allowing the comparison of the same variables in the subgroup of patients who had had at least one serious fall(12 months)
- Timeframe until conversion to major cognitive impairment according to the criteria of NIA-AA of 2011(12 months)
- Patients enrollment rate(12 months)
- 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(6 months and 12 months)
- Satisfaction rate of caregivers assessed by a specific questionnaire (Likert)(12 months)
- Rate of multifallers allowing the comparison of the same variables as those used for the main objective between fallers, non-fallers and multifallers(12 months)
- Rate of serious falls allowing the comparison of the same variables in the subgroup of patients who had had at least one serious fall(12 months)
- Timeframe until conversion to major cognitive impairment according to the criteria of NIA-AA of 2011(12 months)