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Alzheimer DiseaseC3LM-ILADNCT01095718

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

A study testing Errorless Learning, Modeling and Trial and Error in people with Alzheimer Disease, run by Department of Clinical Research and Innovation at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Errorless Learning, Modeling and Trial and Error
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteFrance
Study dates
Mar 2010to Mar 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Dechamps Arnaud, PhD contact

+33 614 564 390

arnauddechamps@yahoo.co.uk

France1 site, 1 recruiting
  • CHU de Nice Centre Mémoire

    Nice

    Philippe ROBERT, PhD.MD

    Recruiting

Other trials in France

About this study

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

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.

Read more

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.
Read the 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.

Being tested
Errorless Learning, Modeling, Trial and Error
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Errorless LearningBehavioural

    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.

  • ModelingBehavioural

    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 ErrorBehavioural

    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 groups in NCT01095718
Study groupRoleWhat they receive
Errorless LearningExperimentalErrorless 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.
Receives: Behavioral: Errorless Learning
ModelingActive comparatorThe 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.
Receives: Behavioral: Modeling
Trial and ErrorActive comparatorTrial 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".
Receives: Behavioral: Trial and Error

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 hours - 2 times a week during 6 weeks

Secondary outcomes (1)
  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.

    Measured: 3 times through the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01095718
Sponsor's protocol ID
ID RCB 2009-A01303-54
Acronym
C3LM-ILAD
Status last verified
Dec 2011
First submitted
15 Mar 2010
Last updated
26 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Errorless Learning, Modeling and Trial and Error in people with Alzheimer Disease, run by Department of Clinical Research and Innovation at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dechamps Arnaud, PhD (+33 614 564 390, arnauddechamps@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.

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