Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE

Not Applicable

Terminated

• Conditions: Driving Habits Patients; Cognitive Impairment
• Interventions: Behavioral: ACCOMPAGNE Education Program; Behavioral: Usuals recommandations

• Registration Number: NCT04493957
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Study Start: 2021-09-06
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
educational intervention	ACCOMPAGNE Education Program	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.
Control group	Usuals recommandations	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.

Primary Outcome Measures

Name	Time	Method
short term setting up self-regulation strategies	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).

Secondary Outcome Measures

Name	Time	Method
Indicators of Mood Effects of Conduct Modifications on the caregivers	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.
Indicators of quality of life effect of Conduct Modifications on the caregivers	two months and six months	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.
long term setting up self-regulation strategies	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.
Indicators of changes perceived by the caregiver	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.
Indicators of burden caregiver effect of Conduct Modifications	two months and six months	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 of program acceptability	two months	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
Indicators on the overall usefulness of the program	two months and six months	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 awareness of driving difficulties	two months and six months	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 driving changes	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.
Indicators of Mood Effects of Conduct Modifications on the patient	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.
Indicators of quality of life effect of Conduct Modifications on the patient	two months and six months	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.

Trial Locations

Locations (1)

Charpennes Hospital; 🇫🇷 Villeurbanne, France