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

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ClinicalTrials.gov Identifier: NCT01095718
Recruitment Status : Unknown
Verified December 2011 by Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : March 30, 2010
Last Update Posted : March 26, 2012
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Fondation Médéric Alzheimer
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE March 15, 2010
First Posted Date  ICMJE March 30, 2010
Last Update Posted Date March 26, 2012
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01095718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of 3 Learning Methods to Improve Independent Activities of Daily Living (IADLs) in Alzheimer Disease
Official Title  ICMJE 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
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:

  1. 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;
  2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks; and
  3. 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:

  1. 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;
  2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks.; and
  3. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Behavioral: 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.

  • 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.

  • Behavioral: Trial and Error

    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.

Study Arms  ICMJE
  • Experimental: 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.

    Intervention: Behavioral: Errorless Learning
  • Active Comparator: 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.

    Intervention: Behavioral: Modeling
  • Active Comparator: 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".

    Intervention: Behavioral: Trial and Error
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 29, 2010)
300
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01095718
Other Study ID Numbers  ICMJE ID RCB 2009-A01303-54
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Department of Clinical Research and Innovation
Collaborators  ICMJE
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Fondation Médéric Alzheimer
Investigators  ICMJE
Principal Investigator: Robert Philippe, MD, PhD Centre Mémoire CHU de Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP