Comparison of 3 Learning Methods and Their Underlying Mechanisms to Improve Independent Living in the Activities of Daily Living in Alzheimer's Dementia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary outcome of the intervention will be the performance and errors of participants. Each task is comparable as the assessment procedure remains the same across disease stages.
研究概览
简要总结
This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe dementia.
Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions for 6 weeks.
This study focuses on the relationship between learning techniques, IADL and memory processes, in a threefold way:
- it will determine which of the of the three learning techniques (EL, MR, TE) will improve most the (re)learning of instrumental skills in different dementia stages using a randomized controlled trial;
- it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks; and
- as a secondary objective, it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.
详细描述
Scientific background and rationale Alzheimer dementia (AD) is the most common cause of progressive cognitive deterioration that alters memory and learning to such a degree that it heavily interferes with daily living. Functional autonomy loss is a key feature of AD, as it follows a slow degradation process in cognitive function and in the ability to perform instrumental activities of daily living (IADL), such as managing finance, food preparation or using a dish washer. Normally, learning occurs in an unstructured manner, which consists of guessing and the occurrence of errors during acquisition (Trial and Error, TE). However, there is abundant evidence that reducing errors during learning (Errorless Learning, EL) or increasing the time period between recall attempts (Modeling with Spaced Retrieval, MR) allow even moderate and severe Alzheimer Dementia (AD) patients to (re)learn instrumental activities of daily living (IADL) such as using a new route, an agenda or a cassette/radio player. While these findings are encouraging, we still do not fully understand the memory mechanisms underlying different learning techniques that are crucial in improving IADL tasks (re)learning and remembering in AD patients. Because acetyl cholinesterase inhibitors or memantine may be active moderators of intervention targeting memory improvement, complex intervention using behavioral enrichment training should explore any drug treatment by behavioral intervention interaction effects.
Description of the project methodology
This study focuses on the relationship between learning techniques, IADL and memory processes, in a threefold way:
- it will determine which of the of the three learning techniques (EL, SR, TE) will improve most the (re)learning of instrumental skills in different dementia stages using a randomized controlled trial;
- it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks.; and
- it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.
- Primary outcome :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a diagnosis of mild to moderately severe Alzheimer Dementia type with a MMSE score between 10 and 26;
- •Fulfill the DSM-IV-TR and NINCDS-ADRDA criteria for Alzheimer's dementia type (33;34);
- •Aged 60 and older;
- •Not able to complete without cue the proposed tasks during the screening interview.
- •Having a Social Security System
排除标准
- •MMSE < 10 or > 26
- •Participants with severe deficits in alertness,
- •Deemed behavioral disturbances (e.g., such as high NPI irritability symptom as defined with a score of 6 or above out of a maximum score of 12),
- •Known medications that could interfere with the intervention (except AD medication, cf AD treatments).
研究组 & 干预措施
Errorless Learning
Errorless learning refers to the use of feedforward instruction before actions to prevent learners from making mistakes. The therapist presents steps with the following instruction and the visual cues e.g., Here are steps that you need to do to make some coffee, please repeat them".
The therapist gives cues before the completion of each step. At each step the patient receives verbal and visual cues. Then cue cards are hidden, and the therapist asks immediately to give the answer about the step involved.
The therapist allows the participant to try finding the solution, if the answer or action is not immediately given, the participant receives a cue, and moves to the next step.
During cueing the patient will mostly receive verbal and visual cues and if necessary physical help.
干预措施: Errorless Learning (Behavioral)
Modeling
The therapist gives the same tailored baseline information for each task. The therapist issue specific information for each step.Using tailored mastery modeling, the therapist shows the steps in front of the patient. There is a special emphasis on adjusting the modeling just above the patient's abilities.
The therapist does the steps, at the same time he/she uses verbal cues during the performance. Then the therapist asks immediately to the patient to do the steps.
干预措施: Modeling (Behavioral)
Trial and Error
Trial and Error refers to the regular unstructured learning and is considered as control condition.
Here the patient is encouraged to complete the task. When there is mistake, the therapist corrects it. Verbal cues will only be provided if the patient is unable to find and complete the correct next step or commit mistakes. The therapist use general instruction: "Here is "task", I will ask you to "actions"", followed by specific instruction, "and I will help you after you have tried".
干预措施: Trial and Error (Behavioral)
结局指标
主要结局
The primary outcome of the intervention will be the performance and errors of participants. Each task is comparable as the assessment procedure remains the same across disease stages.
时间窗: 2 hours - 2 times a week during 6 weeks
次要结局
- Baseline neuropsychological assessments. Premorbid intelligence level will be estimated by the National Adult Reading Test (NART). The Mini Mental State Examination (MMSE) will be used to assessed cognitive status.(3 times through the trial)
研究者
Department of Clinical Research and Innovation
Department of Clinical research and innovation (drc)
Centre Hospitalier Universitaire de Nice