- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04493957
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE (ACCOMPAGNE)
May 15, 2023 updated by: Hospices Civils de Lyon
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Floriane Delphin-Combe
- Phone Number: +33 472433135
- Email: floriane.delphin-combe@chu-lyon.fr
Study Contact Backup
- Name: Melissa Llorens
- Phone Number: +33 472433135
- Email: melissa.llorens@chu-lyon.fr
Study Locations
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-
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Villeurbanne, France, 69100
- Charpennes Hospital
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Contact:
- Floriane Delphin-Combe
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: educational intervention
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.
|
The following workshops will be organised :
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Active Comparator: Control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
short term setting up self-regulation strategies
Time Frame: at 2 months
|
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).
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at 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
long term setting up self-regulation strategies
Time Frame: six months
|
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.
|
six months
|
Indicators of driving changes
Time Frame: two months and six months
|
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.
|
two months and six months
|
Indicators of changes perceived by the caregiver
Time Frame: two months and six months
|
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.
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two months and six months
|
Indicators of awareness of driving difficulties
Time Frame: two months and six months
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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.
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two months and six months
|
Indicators of Mood Effects of Conduct Modifications on the patient
Time Frame: two months and six months
|
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.
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two months and six months
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Indicators of quality of life effect of Conduct Modifications on the patient
Time Frame: two months and six months
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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.
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two months and six months
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Indicators of Mood Effects of Conduct Modifications on the caregivers
Time Frame: two months and six months
|
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.
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two months and six months
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Indicators of quality of life effect of Conduct Modifications on the caregivers
Time Frame: two months and six months
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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.
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two months and six months
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Indicators of burden caregiver effect of Conduct Modifications
Time Frame: two months and six months
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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.
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two months and six months
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Indicators on the overall usefulness of the program
Time Frame: two months and six months
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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?
".
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two months and six months
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Indicators of program acceptability
Time Frame: two months
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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
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two months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2021
Primary Completion (Actual)
November 15, 2022
Study Completion (Actual)
November 15, 2022
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 28, 2020
First Posted (Actual)
July 30, 2020
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL19_0676
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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