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MOBility Disorders Assessment in Patients With Mild COGnitive Disorders

ConditionCognitive Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

elderly patients with MCI followed in memory centers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Gait disorders and falls risk assessment

    Behavioral

    Implementation of a standardized assessment of the fall risk and gait disorders in the memory clinic in addition to usual care.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Existence of at least one fall

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).

Time frame
12 months

Secondary outcomes

1

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

We will compare the rate of fall reported in the "fall's diary" to the collection by monthly phone calls

Time frame
6 months and 12 months
2

Patients enrollment rate

Adherence and acceptability of the multimodal assessment in the memory clinic

Time frame
12 months
3

Satisfaction rate of caregivers assessed by a specific questionnaire (Likert)

Adherence and acceptability of the multimodal assessment in the memory clinic

Time frame
12 months
4

Rate of multifallers allowing the comparison of the same variables as those used for the main objective between fallers, non-fallers and multifallers

The number of patients who fall at least more than 2 times during the study period

Time frame
12 months

Other outcomes

Sponsors and contacts

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University Hospital, Lille

Lead sponsor

Source ClinicalTrials.gov
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