<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493957</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL19_0676</org_study_id>
    <nct_id>NCT04493957</nct_id>
  </id_info>
  <brief_title>Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE</brief_title>
  <acronym>ACCOMPAGNE</acronym>
  <official_title>Evaluation of a Psycho-educational Program Based on the Prevention of the Risks Related to the Impact of Cognitive Disorders on Driving in Geriatrics and Neurology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ACCOMPAGNE study proposes to evaluate an educational program for the patient / caregiver&#xD;
      dyad, intended to accompany the patient towards the implementation of self-regulation&#xD;
      strategies in the driving activity. The program, based on group workshops with the presence&#xD;
      of the patient and the caregiver, is led by an interdisciplinary team. It follows all the&#xD;
      intervention recommendations described in the literature: to make the patient a&#xD;
      decision-maker, to allow advanced planning of discussions between the family member and the&#xD;
      caregiver, to give information on the consequences of TNCs and sensory disorders. This&#xD;
      program provides psychological support in the management of the problems and the mourning of&#xD;
      a future cessation of the driving activity, an awareness of the risky and avoidable&#xD;
      situations, information on alternative solutions and available resources in the event of&#xD;
      reduced driving. The program is created to support the implementation of self-regulation&#xD;
      strategies for safe driving and a gradual reduction of driving activity. This study may be&#xD;
      included in Measure 5 of the Neuro-Degenerative Diseases Plan (PMND) 2014-2019. This plan&#xD;
      recommends to strengthen the self-management of patients and their relatives in the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    new law making inclusion impossible&#xD;
  </why_stopped>
  <start_date type="Actual">September 6, 2021</start_date>
  <completion_date type="Actual">November 15, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>short term setting up self-regulation strategies</measure>
    <time_frame>at 2 months</time_frame>
    <description>The score on the Driver Perception and Practices Questionnaires : DPPQ's &quot;Current Self Regulatory Practices&quot; subscale completed by the patient will be the primary outcome. The scores will be compared at 2 months between the control group and the experimental group. The Current Self Regulatory Practices subscale consists of 8 questions about how often participants set up self-regulation strategies (wait for the rain to stop before driving, ask someone to travel with them rather than drive alone, look for parking to avoid niches, avoid turning left in traffic, avoid taking the freeway, avoid driving at rush hour, avoid driving in crowded places, avoid driving the night). A four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency. The score is calculated by summing the response values on the eight driving situations creating a total score ranging from 0 (never execute any of these strategies) to 24 (often performs all strategies).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>long term setting up self-regulation strategies</measure>
    <time_frame>six months</time_frame>
    <description>The score on the Driver Perception and Practices Questionnaires : DPPQ's &quot;Current Self Regulatory Practices&quot; subscale. The scores will be compared to 6 months between the control group and the experimental group. A four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of driving changes</measure>
    <time_frame>two months and six months</time_frame>
    <description>a composite score with the first part of the Driving Habits Questionnaire (DHQ) used to collect driving habits (number of journeys per day / week / month, number of kilometers traveled, confidence in driving skills) and the other sub- DPPQ scales. The Driver Perception and Practices Questionnaires (DPPQ) have a four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency. the DHQ questionnaire have four-point scale (0 : never, 1 : without any difficulty, 2 : with some difficulty, 3: with moderate difficulty, 4 : with a lot of difficulty) another questions should be answered by yes or no, to assess driving habits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of changes perceived by the caregiver</measure>
    <time_frame>two months and six months</time_frame>
    <description>a composite score with the Driver Perception and Practices Questionnaires (DPPQ) scale supplemented by the caregiver from the observations made on the patient's driving and the first part of the DHQ scale supplemented by the caregiver from the observations made he patient's driving. The DPPQ have a four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency. The Driving Habits Questionnaire (DHQ) have four-point scale (0 : never, 1 : without any difficulty, 2 : with some difficulty, 3: with moderate difficulty, 4 : with a lot of difficulty) another questions should be answered by yes or no, to assess driving habits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of awareness of driving difficulties</measure>
    <time_frame>two months and six months</time_frame>
    <description>score obtained in the second part of the Driving Habits Questionnaire (DHQ) : Driving Habits Questionnaire scale and comparison with the scores obtained on the driving simulator. The Driving Habits Questionnaire (DHQ) have four-point scale (0 : never, 1 : without any difficulty, 2 : with some difficulty, 3: with moderate difficulty, 4 : with a lot of difficulty) another questions should be answered by yes or no, to assess driving habits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of Mood Effects of Conduct Modifications on the patient</measure>
    <time_frame>two months and six months</time_frame>
    <description>The Geriatric Depression Scale Scale 15 items (GDS 15). This scale consists of 15 questions to be answered by yes or no. 0 being the minimum score, 15 being the maximum score. The Geriatric Depression Scale was designed to look for depressive symptoms in older depressive symptoms in elderly subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of quality of life effect of Conduct Modifications on the patient</measure>
    <time_frame>two months and six months</time_frame>
    <description>Quality of Life Quality of Life Alzheimer Disease (QoL-AD) Scale. This scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks in order to evaluate the quality of life of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of Mood Effects of Conduct Modifications on the caregivers</measure>
    <time_frame>two months and six months</time_frame>
    <description>The Geriatric Depression Scale Scale 15 items (GDS 15). This scale consists of 15 questions to be answered by yes or no. 0 being the minimum score, 15 being the maximum score. The Geriatric Depression Scale was designed to look for depressive symptoms in older depressive symptoms in elderly subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of quality of life effect of Conduct Modifications on the caregivers</measure>
    <time_frame>two months and six months</time_frame>
    <description>Quality of Life Quality of Life Alzheimer Disease (QoL-AD) Scale. This scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks in order to evaluate the quality of life of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of burden caregiver effect of Conduct Modifications</measure>
    <time_frame>two months and six months</time_frame>
    <description>The Zarit scale.This scale uses a scale of 1-5 (never, rarely, sometimes, quite often or almost often) to assess hardship or burden assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators on the overall usefulness of the program</measure>
    <time_frame>two months and six months</time_frame>
    <description>The general utility of the program will be measured by adapting a questionnaire from Levasseur et al. (2014) study. This questionnaire focuses on several dimensions. The question is whether the participants found an interest in the program, whether the program allowed them to be more open to the issue of conduct and the link with cognitive disorders, and whether they acquired knowledge in this field. It is also important to know whether participants and caregivers are aware of post-program changes and the implementation of compensatory strategies. The questionnaire will also collect on a scale of Lickert the intention to stop driving at the moment (1: no intention to 4: important intention) as well as the driving cessation by the question &quot;Have you stopped driving, if so, how long? &quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators of program acceptability</measure>
    <time_frame>two months</time_frame>
    <description>Acceptability will be measured by analyzing the proportion of refusals to participate in the study, and enrollment at 2 months in the experimental group. The reason for refusals and stops during the educational sessions will be collected and analyzed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Driving Habits Patients</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>educational intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients and caregivers included in the &quot;ACCOMPAGNE Education Program&quot; group will benefit from seven group workshops spread over three half-days (once a week over 3 consecutive weeks), animated in pairs, each lasting approximately one and a half hours. and using educational pedagogical methods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients and caregivers included in the &quot;Control&quot; group will receive the usual recommendations for driving, issued by their referring doctor in memory consultation during the diagnostic announcement process or during the follow-up of their illness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACCOMPAGNE Education Program</intervention_name>
    <description>The following workshops will be organised :&#xD;
Presentation workshop&#xD;
Cognitive skills&quot; workshop&#xD;
Perception and Environment workshop&#xD;
Responsibilities workshop&#xD;
Representation workshop -&#xD;
Caregivers workshop,&#xD;
Solutions workshop</description>
    <arm_group_label>educational intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usuals recommandations</intervention_name>
    <description>Recommendations consist of a description of the cognitive and sensorimotor risk factors specific to the patient for driving and advice for the adaptation of driving or the recommendation of the stopping of driving. It is usually served by oral or written to the patient, with mention in the patient's file of the recommendation and issued in the presence of his close companion.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 50 and 95 years-old&#xD;
&#xD;
          -  hold a driving license,&#xD;
&#xD;
          -  drive at least twice a week,&#xD;
&#xD;
          -  to have given free and informed consent,&#xD;
&#xD;
          -  present a diagnosis of major or minor CNS according to DSM V, whose clinically&#xD;
             probable or definite etiology is Alzheimer's or related or vascular disease,&#xD;
&#xD;
          -  have a result in the Mini Mental State Examination (MMSE) greater than 18,&#xD;
&#xD;
          -  have the ability to speak orally enough or write enough to perform clinical&#xD;
             evaluations and workshops, be accompanied by a family member present at least 4 hours&#xD;
             a week.&#xD;
&#xD;
        Criteria for inclusion of carers:&#xD;
&#xD;
          -  to be a caregiver helping the patient for activities of daily living,&#xD;
&#xD;
          -  to have given their free and informed consent,&#xD;
&#xD;
          -  have the ability to speak orally and write enough to perform clinical assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have a major psychiatric history, history of alcoholism, anti-depressant&#xD;
&#xD;
          -  have sensory problems preventing participation in workshops,&#xD;
&#xD;
          -  be affected by any debilitating pathology compromising the health of the patient in&#xD;
             the short and medium term,&#xD;
&#xD;
          -  be unable to express consent. Criteria for non-inclusion of caregivers: have sensory&#xD;
             disturbances preventing participation in workshops.&#xD;
&#xD;
        Recruited patients and caregivers should have been informed and signed a consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charpennes Hospital</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>driving habits</keyword>
  <keyword>cognitive impairment</keyword>
  <keyword>prevention</keyword>
  <keyword>educational intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493957
org study id: 69HCL19_0676
nct id: NCT04493957
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
ACCOMPAGNE study proposes to evaluate an educational program for the patient / caregiver
      dyad, intended to accompany the patient towards the implementation of self-regulation
      strategies in the driving activity. The program, based on group workshops with the presence
      of the patient and the caregiver, is led by an interdisciplinary team. It follows all the
      intervention recommendations described in the literature: to make the patient a
      decision-maker, to allow advanced planning of discussions between the family member and the
      caregiver, to give information on the consequences of TNCs and sensory disorders. This
      program provides psychological support in the management of the problems and the mourning of
      a future cessation of the driving activity, an awareness of the risky and avoidable
      situations, information on alternative solutions and available resources in the event of
      reduced driving. The program is created to support the implementation of self-regulation
      strategies for safe driving and a gradual reduction of driving activity. This study may be
      included in Measure 5 of the Neuro-Degenerative Diseases Plan (PMND) 2014-2019. This plan
      recommends to strengthen the self-management of patients and their relatives in the disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Single Blind
measure: short term setting up self-regulation strategies
time frame: at 2 months
description: The score on the Driver Perception and Practices Questionnaires : DPPQ's "Current Self Regulatory Practices" subscale completed by the patient will be the primary outcome. The scores will be compared at 2 months between the control group and the experimental group. The Current Self Regulatory Practices subscale consists of 8 questions about how often participants set up self-regulation strategies (wait for the rain to stop before driving, ask someone to travel with them rather than drive alone, look for parking to avoid niches, avoid turning left in traffic, avoid taking the freeway, avoid driving at rush hour, avoid driving in crowded places, avoid driving the night). A four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency. The score is calculated by summing the response values on the eight driving situations creating a total score ranging from 0 (never execute any of these strategies) to 24 (often performs all strategies).
measure: long term setting up self-regulation strategies
time frame: six months
description: The score on the Driver Perception and Practices Questionnaires : DPPQ's "Current Self Regulatory Practices" subscale. The scores will be compared to 6 months between the control group and the experimental group. A four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency.
measure: Indicators of driving changes
time frame: two months and six months
description: a composite score with the first part of the Driving Habits Questionnaire (DHQ) used to collect driving habits (number of journeys per day / week / month, number of kilometers traveled, confidence in driving skills) and the other sub- DPPQ scales. The Driver Perception and Practices Questionnaires (DPPQ) have a four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency. the DHQ questionnaire have four-point scale (0 : never, 1 : without any difficulty, 2 : with some difficulty, 3: with moderate difficulty, 4 : with a lot of difficulty) another questions should be answered by yes or no, to assess driving habits.
measure: Indicators of changes perceived by the caregiver
time frame: two months and six months
description: a composite score with the Driver Perception and Practices Questionnaires (DPPQ) scale supplemented by the caregiver from the observations made on the patient's driving and the first part of the DHQ scale supplemented by the caregiver from the observations made he patient's driving. The DPPQ have a four-point scale (0: never, 1: rarely, 2: sometimes, 3: often) collects the frequency. The Driving Habits Questionnaire (DHQ) have four-point scale (0 : never, 1 : without any difficulty, 2 : with some difficulty, 3: with moderate difficulty, 4 : with a lot of difficulty) another questions should be answered by yes or no, to assess driving habits.
measure: Indicators of awareness of driving difficulties
time frame: two months and six months
description: score obtained in the second part of the Driving Habits Questionnaire (DHQ) : Driving Habits Questionnaire scale and comparison with the scores obtained on the driving simulator. The Driving Habits Questionnaire (DHQ) have four-point scale (0 : never, 1 : without any difficulty, 2 : with some difficulty, 3: with moderate difficulty, 4 : with a lot of difficulty) another questions should be answered by yes or no, to assess driving habits.
measure: Indicators of Mood Effects of Conduct Modifications on the patient
time frame: two months and six months
description: The Geriatric Depression Scale Scale 15 items (GDS 15). This scale consists of 15 questions to be answered by yes or no. 0 being the minimum score, 15 being the maximum score. The Geriatric Depression Scale was designed to look for depressive symptoms in older depressive symptoms in elderly subjects.
measure: Indicators of quality of life effect of Conduct Modifications on the patient
time frame: two months and six months
description: Quality of Life Quality of Life Alzheimer Disease (QoL-AD) Scale. This scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks in order to evaluate the quality of life of patients.
measure: Indicators of Mood Effects of Conduct Modifications on the caregivers
time frame: two months and six months
description: The Geriatric Depression Scale Scale 15 items (GDS 15). This scale consists of 15 questions to be answered by yes or no. 0 being the minimum score, 15 being the maximum score. The Geriatric Depression Scale was designed to look for depressive symptoms in older depressive symptoms in elderly subjects.
measure: Indicators of quality of life effect of Conduct Modifications on the caregivers
time frame: two months and six months
description: Quality of Life Quality of Life Alzheimer Disease (QoL-AD) Scale. This scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks in order to evaluate the quality of life of patients.
measure: Indicators of burden caregiver effect of Conduct Modifications
time frame: two months and six months
description: The Zarit scale.This scale uses a scale of 1-5 (never, rarely, sometimes, quite often or almost often) to assess hardship or burden assessment.
measure: Indicators on the overall usefulness of the program
time frame: two months and six months
description: The general utility of the program will be measured by adapting a questionnaire from Levasseur et al. (2014) study. This questionnaire focuses on several dimensions. The question is whether the participants found an interest in the program, whether the program allowed them to be more open to the issue of conduct and the link with cognitive disorders, and whether they acquired knowledge in this field. It is also important to know whether participants and caregivers are aware of post-program changes and the implementation of compensatory strategies. The questionnaire will also collect on a scale of Lickert the intention to stop driving at the moment (1: no intention to 4: important intention) as well as the driving cessation by the question "Have you stopped driving, if so, how long? ".
measure: Indicators of program acceptability
time frame: two months
description: Acceptability will be measured by analyzing the proportion of refusals to participate in the study, and enrollment at 2 months in the experimental group. The reason for refusals and stops during the educational sessions will be collected and analyzed
arm group label: educational intervention
arm group type: Experimental
description: Patients and caregivers included in the "ACCOMPAGNE Education Program" group will benefit from seven group workshops spread over three half-days (once a week over 3 consecutive weeks), animated in pairs, each lasting approximately one and a half hours. and using educational pedagogical methods.
arm group label: Control group
arm group type: Active Comparator
description: Patients and caregivers included in the "Control" group will receive the usual recommendations for driving, issued by their referring doctor in memory consultation during the diagnostic announcement process or during the follow-up of their illness.
intervention type: Behavioral
intervention name: ACCOMPAGNE Education Program
description: The following workshops will be organised :
Presentation workshop
Cognitive skills" workshop
Perception and Environment workshop
Responsibilities workshop
Representation workshop -
Caregivers workshop,
Solutions workshop
arm group label: educational intervention
intervention type: Behavioral
intervention name: Usuals recommandations
description: Recommendations consist of a description of the cognitive and sensorimotor risk factors specific to the patient for driving and advice for the adaptation of driving or the recommendation of the stopping of driving. It is usually served by oral or written to the patient, with mention in the patient's file of the recommendation and issued in the presence of his close companion.
arm group label: Control group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Cognitive Dysfunction