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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
France1 site, 1 recruiting
- Recruiting
CHU de Nice Centre Mémoire
Nice
Philippe ROBERT, PhD.MD
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:
- 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.
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:
- 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.
- Conditions
- Alzheimer Disease
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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". Receives: Behavioral: Trial and Error |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted30 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Department of Clinical Research and Innovation
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Fondation Mederic Alzheimer
- Responsible party
- Sponsor-investigator, Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
- Investigators
- Robert Philippe, MD, PhD, Principal investigator, Centre Mémoire CHU de Nice
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01095718
- Acronym / sponsor ID
- C3LM-ILAD / ID RCB 2009-A01303-54
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Department of Clinical Research and InnovationUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Fondation Mederic Alzheimer
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (estimated)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Errorless Learning | Experimental | Behavioral: Errorless LearningErrorless 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. |
| Modeling | Active comparator | Behavioral: ModelingThe 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 | Active comparator | Behavioral: Trial and ErrorTrial 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". |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Errorless LearningErrorless 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. | Behavioural | Errorless Learning |
| ModelingThe 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. | Behavioural | Modeling |
| Trial and ErrorThe 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. | Behavioural | Trial and Error |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Philippe, MD, PhD principal investigator
Centre Mémoire CHU de Nice
1 site in 1 country: see every site and its status.
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.