Driving Habits PatientsACCOMPAGNENCT04493957
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE
A study testing ACCOMPAGNE Education Program and Usuals recommandations in people with Driving Habits Patients and Cognitive Impairment, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Driving Habits Patients, Cognitive Impairment
- What is being tested?
- ACCOMPAGNE Education Program and Usuals recommandations
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2021to 15 Nov 2022
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Driving Habits Patients, Cognitive Impairment
- Being tested
- ACCOMPAGNE Education Program, Usuals recommandations
- Keywords
- driving habits, cognitive impairment, prevention, educational intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCOMPAGNE Education ProgramBehavioural
The following workshops will be organised :
- Presentation workshop
- Cognitive skills" workshop
- Perception and Environment workshop
- Responsibilities workshop
- Representation workshop -
- Caregivers workshop,
- Solutions workshop
Usuals recommandationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| educational intervention | Experimental | 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. Receives: Behavioral: ACCOMPAGNE Education Program |
| Control group | Active comparator | 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. Receives: Behavioral: Usuals recommandations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 2 months
Secondary outcomes (11)
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.
Measured: six months
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.
Measured: two months and six months
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.
Measured: two months and six months
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.
Measured: two months and six months
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.
Measured: two months and six months
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.
Measured: two months and six months
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.
Measured: two months and six months
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.
Measured: two months and six months
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.
Measured: two months and six months
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? ".
Measured: two months and six months
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
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start6 Sep 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Why it stopped: new law making inclusion impossible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Driving Habits PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493957
- Sponsor's protocol ID
- 69HCL19_0676
- Acronym
- ACCOMPAGNE
- Status last verified
- May 2023
- First submitted
- 28 Jul 2020
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35923824
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04493957
- Acronym / sponsor ID
- ACCOMPAGNE / 69HCL19_0676
- Conditions
- Driving Habits Patients, Cognitive Impairment
- Keywords
- driving habits, cognitive impairment, prevention, educational intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new law making inclusion impossible
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| educational intervention | Experimental | Behavioral: ACCOMPAGNE Education ProgramPatients 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. |
| Control group | Active comparator | Behavioral: Usuals recommandationsPatients 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. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| ACCOMPAGNE Education ProgramThe following workshops will be organised : * Presentation workshop * Cognitive skills" workshop * Perception and Environment workshop * Responsibilities workshop * Representation workshop - * Caregivers workshop, * Solutions workshop | Behavioural | educational intervention |
| Usuals recommandationsRecommendations 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. | Behavioural | Control group |
Primary outcome
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).
11 secondary outcomes
long term setting up self-regulation strategies
Time frame: six months
Indicators of driving changes
Time frame: two months and six months
Indicators of changes perceived by the caregiver
Time frame: two months and six months
Indicators of awareness of driving difficulties
Time frame: two months and six months
Indicators of Mood Effects of Conduct Modifications on the patient
Time frame: two months and six months
Indicators of quality of life effect of Conduct Modifications on the patient
Time frame: two months and six months
Indicators of Mood Effects of Conduct Modifications on the caregivers
Time frame: two months and six months
Indicators of quality of life effect of Conduct Modifications on the caregivers
Time frame: two months and six months
Indicators of burden caregiver effect of Conduct Modifications
Time frame: two months and six months
Indicators on the overall usefulness of the program
Time frame: two months and six months
Indicators of program acceptability
Time frame: two months
Results and safety
The study was stopped early (reason given: new law making inclusion impossible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 35923824Delphin-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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACCOMPAGNE Education Program and Usuals recommandations in people with Driving Habits Patients and Cognitive Impairment, run by Hospices Civils de Lyon 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 11 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 May 2023. 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?
The study was stopped early (reason given: new law making inclusion impossible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short term setting up self-regulation strategies (time frame: at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493957, which also lists 1 linked publication.
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 17 May 2023.