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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- short term setting up self-regulation strategies
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single Blind
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
short term setting up self-regulation strategies
时间窗: 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).
次要结局
- Indicators of Mood Effects of Conduct Modifications on the caregivers(two months and six months)
- Indicators of quality of life effect of Conduct Modifications on the caregivers(two months and six months)
- long term setting up self-regulation strategies(six months)
- Indicators of changes perceived by the caregiver(two months and six months)
- Indicators of burden caregiver effect of Conduct Modifications(two months and six months)
- Indicators of program acceptability(two months)
- Indicators on the overall usefulness of the program(two months and six months)
- Indicators of awareness of driving difficulties(two months and six months)
- Indicators of driving changes(two months and six months)
- Indicators of Mood Effects of Conduct Modifications on the patient(two months and six months)
- Indicators of quality of life effect of Conduct Modifications on the patient(two months and six months)