Clinical trial NCT04493957: Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : 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
Overall status: TERMINATED
Phase: NA
Conditions: Driving Habits Patients
Cognitive Impairment
Keywords: driving habits
cognitive impairment
prevention
educational intervention
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: short term setting up self-regulation strategies
timeFrame: at 2 months
Secondary outcomes:
measure: long term setting up self-regulation strategies
timeFrame: six months
measure: Indicators of driving changes
timeFrame: two months and six months
measure: Indicators of changes perceived by the caregiver
timeFrame: two months and six months
measure: Indicators of awareness of driving difficulties
timeFrame: two months and six months
measure: Indicators of Mood Effects of Conduct Modifications on the patient
timeFrame: two months and six months
measure: Indicators of quality of life effect of Conduct Modifications on the patient
timeFrame: two months and six months
measure: Indicators of Mood Effects of Conduct Modifications on the caregivers
timeFrame: two months and six months
measure: Indicators of quality of life effect of Conduct Modifications on the caregivers
timeFrame: two months and six months
measure: Indicators of burden caregiver effect of Conduct Modifications
timeFrame: two months and six months
measure: Indicators on the overall usefulness of the program
timeFrame: two months and six months
measure: Indicators of program acceptability
timeFrame: two months
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Charpennes Hospital
Study officials:
References:
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.