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Comparison of 3 Learning Methods to Improve Independent Activities of Daily Living (IADLs) in Alzheimer Disease (C3LM-ILAD)

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Errorless Learning
Modeling
Trial and Error
Sponsored by
Department of Clinical Research and Innovation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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).

Sites / Locations

  • CHU de Nice Centre MémoireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Errorless Learning

Modeling

Trial and Error

Arm Description

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.

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.

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".

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 15, 2010
Last Updated
March 23, 2012
Sponsor
Department of Clinical Research and Innovation
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Fondation Mederic Alzheimer
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1. Study Identification

Unique Protocol Identification Number
NCT01095718
Brief Title
Comparison of 3 Learning Methods to Improve Independent Activities of Daily Living (IADLs) in Alzheimer Disease
Acronym
C3LM-ILAD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Department of Clinical Research and Innovation
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Fondation Mederic Alzheimer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 : Is the (re)learning effectiveness (physical performance) of each procedure and the overall maintain of the autonomy. All intervention are individualized training. The learning procedure comparison will allow us to assess the (re) learning capacities of IADL tasks in AD patients according to severity stages from mild to moderately severe. • Secondary outcome : Assessing the role of the implicit memory processes over the explicit memory processes in the (re)learning of IADL tasks. Overall effects of the intervention over the patient's autonomy, cognitive functioning, behavioral disturbances, quality of life and careers burden. Settings: Nursing Homes, Day Care centers, Memory Clinics Locations: Nijmegen, The Netherlands and Nice and Bordeaux agglomerations, France 3 different interventions given in individual sessions at participant's facility. Each intervention is a 6-week training with a post assessment at 4-week follow-up. Each participant will receive one of the 3 interventions for 2 hours twice a week in individual sessions. Errorless learning(EL) refers to the use of feedforward instruction (i.e., how to do) before actions to prevent learners from making mistakes. Modeling with Spaced Retrieval (MR) techniques refers to the modeling of the steps and the increasing time interval between the completion of the task and the rehearsal of the targeted information by the patient. Trial and Error (TE) refers to the regular unstructured learning and is considered as control condition. A standardized 1-week training has been developed in French and Dutch to train French and Dutch therapists at each learning techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Errorless Learning
Arm Type
Experimental
Arm Description
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.
Arm Title
Modeling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Trial and Error
Arm Type
Active Comparator
Arm Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Errorless Learning
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modeling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trial and Error
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
2 hours - 2 times a week during 6 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
3 times through the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dechamps Arnaud, PhD
Phone
+33 614 564 390
Email
arnauddechamps@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Philippe, MD, PhD
Organizational Affiliation
Centre Mémoire CHU de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice Centre Mémoire
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PhD.MD

12. IPD Sharing Statement

Learn more about this trial

Comparison of 3 Learning Methods to Improve Independent Activities of Daily Living (IADLs) in Alzheimer Disease

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