Back to resultsEvaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE (ACCOMPAGNE)
Primary Purpose
Driving Habits Patients, Cognitive Impairment
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ACCOMPAGNE Education Program
Usuals recommandations
Sponsored by
About this trial
This is an interventional other trial for Driving Habits Patients focused on measuring driving habits, cognitive impairment, prevention, educational intervention
Eligibility Criteria
Inclusion Criteria:
- aged between 50 and 95 years-old
- hold a driving license,
- drive at least twice a week,
- to have given free and informed consent,
- present a diagnosis of major or minor CNS according to DSM V, whose clinically probable or definite etiology is Alzheimer's or related or vascular disease,
- have a result in the Mini Mental State Examination (MMSE) greater than 18,
- have the ability to speak orally enough or write enough to perform clinical evaluations and workshops, be accompanied by a family member present at least 4 hours a week.
Criteria for inclusion of carers:
- to be a caregiver helping the patient for activities of daily living,
- to have given their free and informed consent,
- have the ability to speak orally and write enough to perform clinical assessments.
Exclusion Criteria:
- have a major psychiatric history, history of alcoholism, anti-depressant
- have sensory problems preventing participation in workshops,
- be affected by any debilitating pathology compromising the health of the patient in the short and medium term,
- be unable to express consent. Criteria for non-inclusion of caregivers: have sensory disturbances preventing participation in workshops.
Recruited patients and caregivers should have been informed and signed a consent.
Sites / Locations
- Charpennes Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
educational intervention
Control group
Arm 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.
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.
Outcomes
Primary Outcome Measures
short term setting up self-regulation strategies
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).
Secondary Outcome Measures
long term setting up self-regulation strategies
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.
Indicators of driving changes
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.
Indicators of changes perceived by the caregiver
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.
Indicators of awareness of driving difficulties
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.
Indicators of Mood Effects of Conduct Modifications on the patient
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.
Indicators of quality of life effect of Conduct Modifications on the patient
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.
Indicators of Mood Effects of Conduct Modifications on the caregivers
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.
Indicators of quality of life effect of Conduct Modifications on the caregivers
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.
Indicators of burden caregiver effect of Conduct Modifications
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.
Indicators on the overall usefulness of the program
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? ".
Indicators of program acceptability
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04493957
Brief Title
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE
Acronym
ACCOMPAGNE
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
new law making inclusion impossible
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Driving Habits Patients, Cognitive Impairment
Keywords
driving habits, cognitive impairment, prevention, educational intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single Blind
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
educational intervention
Arm Type
Experimental
Arm 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 Title
Control group
Arm Type
Active Comparator
Arm 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(s)
ACCOMPAGNE Education Program
Intervention Description
The following workshops will be organised :
Presentation workshop
Cognitive skills" workshop
Perception and Environment workshop
Responsibilities workshop
Representation workshop -
Caregivers workshop,
Solutions workshop
Intervention Type
Behavioral
Intervention Name(s)
Usuals recommandations
Intervention 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.
Primary Outcome Measure Information:
Title
short term setting up self-regulation strategies
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).
Time Frame
at 2 months
Secondary Outcome Measure Information:
Title
long term setting up self-regulation strategies
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.
Time Frame
six months
Title
Indicators of driving changes
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.
Time Frame
two months and six months
Title
Indicators of changes perceived by the caregiver
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.
Time Frame
two months and six months
Title
Indicators of awareness of driving difficulties
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.
Time Frame
two months and six months
Title
Indicators of Mood Effects of Conduct Modifications on the patient
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.
Time Frame
two months and six months
Title
Indicators of quality of life effect of Conduct Modifications on the patient
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.
Time Frame
two months and six months
Title
Indicators of Mood Effects of Conduct Modifications on the caregivers
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.
Time Frame
two months and six months
Title
Indicators of quality of life effect of Conduct Modifications on the caregivers
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.
Time Frame
two months and six months
Title
Indicators of burden caregiver effect of Conduct Modifications
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.
Time Frame
two months and six months
Title
Indicators on the overall usefulness of the program
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? ".
Time Frame
two months and six months
Title
Indicators of program acceptability
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
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged between 50 and 95 years-old
hold a driving license,
drive at least twice a week,
to have given free and informed consent,
present a diagnosis of major or minor CNS according to DSM V, whose clinically probable or definite etiology is Alzheimer's or related or vascular disease,
have a result in the Mini Mental State Examination (MMSE) greater than 18,
have the ability to speak orally enough or write enough to perform clinical evaluations and workshops, be accompanied by a family member present at least 4 hours a week.
Criteria for inclusion of carers:
to be a caregiver helping the patient for activities of daily living,
to have given their free and informed consent,
have the ability to speak orally and write enough to perform clinical assessments.
Exclusion Criteria:
have a major psychiatric history, history of alcoholism, anti-depressant
have sensory problems preventing participation in workshops,
be affected by any debilitating pathology compromising the health of the patient in the short and medium term,
be unable to express consent. Criteria for non-inclusion of caregivers: have sensory disturbances preventing participation in workshops.
Recruited patients and caregivers should have been informed and signed a consent.
Facility Information:
Facility Name
Charpennes Hospital
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35923824
Citation
Delphin-Combe F, Coste MH, Bachelet R, Llorens M, Gentil C, Giroux M, Paire-Ficout L, Ranchet M, Krolak-Salmon P. An innovative therapeutic educational program to support older drivers with cognitive disorders: Description of a randomized controlled trial study protocol. Front Neurol. 2022 Jul 18;13:901100. doi: 10.3389/fneur.2022.901100. eCollection 2022.
Results Reference
derived
Learn more about this trial
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE
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