RETROUVE : Study of the Return to Driving in People Who Have Suffered a Cerebrovascular Accident (CVA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Rate of return to driving after stroke
研究概览
简要总结
The RETROUVE study will provide healthcare professionals, patients and their families informations on the rate of return to driving in people who have suffered a stroke, and will provide a better understanding of the various factors that explain this return. This bi-centric study is being conducted in 2 parts: a retrospective part involving an analysis of medical records, and a prospective part involving a telephone questionnaire.
The main aim of this study is to assess the rate of return to driving in patients who have suffered a stroke, following an assessment of their fitness to drive. It will also aim to study the factors that explain a return to driving in post-stroke patients.
详细描述
This study aims to evaluate the rate of return to driving among stroke patients who underwent a formal fitness-to-drive assessment at the Kerpape CMRRF or Henry Gabrielle Hospital in 2019. Stroke patients may experience impairments in motor, cognitive, and executive functions, which can affect their ability to drive safely. The assessment involves a multidisciplinary evaluation including medical examination (vision, hearing, motor coordination), neuropsychological assessment (executive functions, attention, processing speed), and an on-road or simulator-based driving evaluation conducted by a driving instructor and occupational therapist.
The study consists of two phases:
Retrospective Analysis: Medical records of patients who underwent the driving assessment in 2019 will be reviewed. Collected variables include demographic characteristics (age, gender, education level), clinical data (stroke type, severity, comorbidities, medications affecting alertness), and driving assessment outcomes (favorable, unfavorable, or favorable with restrictions). The analysis will compare patients who were judged fit to drive with those who were judged unfit, in order to identify factors associated with a favorable driving outcome. Statistical methods include Chi-square tests, Student's t-tests or Wilcoxon tests depending on data distribution, and logistic regression to identify influential clinical, demographic, and driving-related factors.
Telephone Follow-Up: Approximately three years after the initial assessment, participants will be contacted by telephone to complete a follow-up questionnaire. The questionnaire evaluates current driving practices, limitations, perceived difficulties, and strategies adopted since the stroke. Telephone interviews are conducted by research staff and last approximately one hour.
All participants identified through medical records are informed about the study and their non-objection is recorded in the medical file. Data collection and analyses will adhere to the intention-to-treat principle. Missing data will be included in analyses, and any additional exploratory analyses will be clearly documented in the final report.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥ 18 years and ≤ 85
- •Having suffered a stroke (ischaemic and/or haemorrhagic)
- •Having completed a driving assessment in 2019 at one of the 2 centres participating in the study
- •Have not objected to taking part in the study
排除标准
- •Protected adults (guardianship)
- •Insufficient command of the French language
- •Deceased patients
结局指标
主要结局
Rate of return to driving after stroke
时间窗: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Proportion of stroke patients assessed as fit to drive (favorable decision) by the multidisciplinary team and the registered physician, based on the 2019 driving assessments at Kerpape CMRRF or Henry Gabrielle Hospital.
Demographic factors associated with return to driving
时间窗: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Age, gender, and education level of stroke patients, analyzed according to the opinion of the multidisciplinary team and the registered physician (favorable, unfavorable, or favorable with restrictions).
Clinical factors associated with return to driving
时间窗: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Clinical characteristics of stroke patients (stroke type, lesion side and date, comorbidities) analyzed according to the opinion of the multidisciplinary team and the registered physician (favorable, unfavorable, or favorable with restrictions).
次要结局
- Evaluate the maintenance of driving three years after a stroke and any changes in driving habits and/or practices, as well as driving habits and/or practices, as well as any new strategies brought about.(From end of 2019 assessment to date of telephone questionnaire in 2022, assessed prospectively.)