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

NCT01095718 | Unknown

• 1 other identifier: ID RCB 2009-A01303-54
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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. 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. 2.it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks; and
3. 3.as a secondary objective, it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours - 2 times a week during 6 weeks

Secondary Outcomes (1)

• 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

Study Arms (3)

Errorless Learning

EXPERIMENTAL

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

Modeling

ACTIVE COMPARATOR

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

Trial and Error

ACTIVE COMPARATOR

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

Interventions

Errorless Learning BEHAVIORAL

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.

Errorless Learning

Modeling BEHAVIORAL

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.

Modeling

Trial and Error BEHAVIORAL

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Department of Clinical Research and Innovation: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Fondation Mederic Alzheimer: collaborator

Study Sites (1)

CHU de Nice Centre Mémoire

Nice, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert Philippe, MD, PhD

  Centre Mémoire CHU de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dechamps Arnaud, PhD

CONTACT

+33 614 564 390; arnauddechamps@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Clinical research and innovation (drc)

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 30, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: March 26, 2012

Record last verified: 2011-12

Locations

FR (1)