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

NCT04493957 | Terminated

• 1 other identifier: 69HCL19_0676
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

driving habits; cognitive impairment; prevention; educational intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  at 2 months

Secondary Outcomes (11)

• long term setting up self-regulation strategies

  six months

• Indicators of driving changes

  two months and six months

• Indicators of changes perceived by the caregiver

  two months and six months

• Indicators of awareness of driving difficulties

  two months and six months

• Indicators of Mood Effects of Conduct Modifications on the patient

  two months and six months

Study Arms (2)

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.

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.

Behavioral: Usuals recommandations

Interventions

ACCOMPAGNE Education Program BEHAVIORAL

The following workshops will be organised : * Presentation workshop * Cognitive skills" workshop * Perception and Environment workshop * Responsibilities workshop * Representation workshop - * Caregivers workshop, * Solutions workshop

educational intervention

Usuals recommandations 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.

Control group

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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,
• Recruited patients and caregivers should have been informed and signed a consent.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Charpennes Hospital

Villeurbanne, 69100, France

Location

Related Publications (1)

• 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.

  PMID: 35923824 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: September 6, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

FR (1)