Evaluation of the Feasibility, Practicality, and Interest of the 3D Ephemeris, a Tool for the Rehabilitation of Temporal Orientation Disorder in People With Alzheimer's Disease or Related Dementia: Monocentric Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of Temporal Orientation Rehabilitation with the Ephéméride 3D Tool
研究概览
简要总结
In geriatric care, occupational therapists use validated tools to assess abilities and performance, identifying deficiencies and proposing rehabilitation programs. Temporal orientation disorders are common, with studies showing that individuals who make mistakes in identifying time are at higher risk of dementia. Temporal orientation issues typically precede spatial orientation problems in Alzheimer's, especially in hospital settings where environmental cues are lost. Maintaining temporal orientation during hospitalization is crucial. While no effective rehabilitation tool currently exists, a new prototype has been developed to address temporal orientation disorders in Alzheimer's and dementia patients, with plans for further evaluation.
Main Objective Evaluate in real-life conditions the effectiveness of an adapted external aid, such as the Ephéméride 3D tool, in improving temporal orientation rehabilitation for individuals with Alzheimer's disease or related dementias in the mild to moderate stages.
Secondary Objectives
Assess the feasibility of establishing a routine with hospitalized patients. Gather feedback from patients, their families, and healthcare professionals regarding the external aid (usefulness, practicality, and aesthetics) as a prototype.
Evaluate the desire to continue using the tool once patients return home. Count the number of ephémérides deemed appropriate based on positive feedback from patients, families, and healthcare professionals. This figure is valuable for the company that may decide to scale up the product development. It will be calculated from the results of the attached questionnaires.
Method
This is a monocentric pilot observational study with data collection based on the following steps:
Day 5 (D5): Initial MMSE by the patient's physician. Prescription of temporal rehabilitation.
Day 6 (D6): Obtaining consent from the patient and their caregiver. Days 6 to 10 (D6 to D10): Daily assessment of the patient's knowledge of the season, year, month, day of the month (date), and day of the week without external aid (E3D).
Days 11 to 15 (D11 to D15): Daily assessment with external aid (E3D) for the same temporal knowledge.
Day 16 (D16): Interim and partial MMSE by the patient's physician. Days 17 to 21 (D17 to D21): Daily assessment without external aid (E3D). Days 22 to 26 (D22 to D26): Daily assessment with external aid (E3D). Day 27 (D27): Final and complete MMSE by the patient's physician. Days 28 to 30 (D28 to D30): Questionnaires for the patient, their caregiver, and healthcare professionals (including the study referent in the hospital).
20 patients will be included over a 1-year and 30-day period. Descriptive statistical analyses will be conducted to document patient characteristics at admission and the evolution of key parameters over time (D0 to D30). Paired statistical tests (T-tests/Chi-square) will be performed to identify significant changes between visit times. Longitudinal analyses using mixed-effects linear regression models will assess trends over time, accounting for correlations between repeated measures and evaluating differences based on the use of external aids.
Conclusion This observational study primarily aims to describe the feasibility and benefits of using the Ephéméride 3D tool to support temporal orientation rehabilitation in individuals with mild to moderate dementia.
详细描述
Context and Purpose In geriatric care, especially for individuals with Alzheimer's disease or other dementias, maintaining orientation in time (temporal orientation) is a critical aspect of cognitive function. Occupational therapists, using validated tools, help assess a patient's abilities and performance to identify deficiencies and propose rehabilitation programs tailored to the individual. Temporal orientation disorders, in which individuals struggle with identifying or understanding time (such as the day of the week, month, or year), are common in patients with Alzheimer's disease and related dementias. Research shows that individuals who make errors in temporal orientation-such as misidentifying the day, date, or month-are at a higher risk for developing dementia. Furthermore, temporal orientation issues often precede spatial orientation problems in Alzheimer's patients, meaning they can serve as early indicators of cognitive decline.
In hospital settings, these issues are often worsened due to the loss of personal environmental cues, which can leave patients feeling disoriented and confused. As such, maintaining temporal orientation during hospitalization is essential to reduce distress and support cognitive function. However, despite the clear importance of addressing temporal orientation in dementia care, there is currently no effective tool specifically designed to rehabilitate these deficits. This gap in care has prompted the development of a new tool, the Ephéméride 3D, a prototype external aid aimed at improving temporal orientation in individuals with mild to moderate dementia.
Main Objective The primary goal of this study is to evaluate, in real-life hospital conditions, the effectiveness of the Ephéméride 3D tool in improving temporal orientation rehabilitation for individuals with Alzheimer's disease or related dementias. Specifically, the study focuses on patients in the mild to moderate stages of the disease, where early intervention could be most beneficial.
Secondary Objectives
In addition to evaluating the tool's effectiveness, the study includes several secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 ≥ 65 years old.
- •Patient presenting with temporal orientation impairment during the MMSE test.
- •Patient with an MMSE score above 20 (mild stage) or a score between 10 and 20 (moderate stage).
- •Patient who has not expressed any objection.
排除标准
- •Presence of one or more disruptive behavioral disorders.
- •Presence of confusion of unknown origin.
- •Visual blindness.
- •Inability to read or understand French.
结局指标
主要结局
Evaluation of Temporal Orientation Rehabilitation with the Ephéméride 3D Tool
时间窗: 30 days
This outcome measure assesses the effectiveness of the Ephéméride 3D tool in improving temporal orientation for individuals with Alzheimer's disease or related dementias in the mild to moderate stages. It is based on daily assessments of the patient's knowledge of time-related information, including season, year, month, day of the month (date), and day of the week, both with and without the use of the external aid (E3D)
次要结局
未报告次要终点