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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Fondation Mederic Alzheimer
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01095718
First received: March 15, 2010
Last updated: March 23, 2012
Last verified: December 2011
  Purpose

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.

Condition Intervention
Alzheimer Disease
Behavioral: Errorless Learning
Behavioral: Modeling
Behavioral: Trial and Error

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

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. [ Time Frame: 2 hours - 2 times a week during 6 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 3 times through the trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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.

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.

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".

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095718

Contacts
Contact: Dechamps Arnaud, PhD +33 614 564 390 arnauddechamps@yahoo.co.uk

Locations
France
CHU de Nice Centre Mémoire Recruiting
Nice, France
Principal Investigator: Philippe ROBERT, PhD.MD         
Sponsors and Collaborators
Department of Clinical Research and Innovation
Institut National de la Santé Et de la Recherche Médicale, France
Fondation Mederic Alzheimer
Investigators
Principal Investigator: Robert Philippe, MD, PhD Centre Mémoire CHU de Nice
  More Information

No publications provided

Responsible Party: Department of Clinical Research and Innovation, Department of Clinical research and innovation (drc), Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01095718     History of Changes
Other Study ID Numbers: ID RCB 2009-A01303-54
Study First Received: March 15, 2010
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014