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

NCT ID: NCT04493957

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2022-11-15

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.

Conditions

Driving Habits Patients; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ACCOMPAGNE Education Program

Intervention Type: BEHAVIORAL

The following workshops will be organised :

• Presentation workshop
• Cognitive skills" workshop
• Perception and Environment workshop
• Responsibilities workshop
• Representation workshop -
• Caregivers workshop,
• Solutions workshop

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.

Group Type: ACTIVE_COMPARATOR

Usuals recommandations

Intervention Type: BEHAVIORAL

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.

Interventions

ACCOMPAGNE Education Program

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

Usuals recommandations

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Charpennes Hospital

Villeurbanne, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35923824 (View on PubMed)

Other Identifiers

69HCL19_0676

Identifier Type: -

Identifier Source: org_study_id