- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05872490
Predictors Associated With Maintaining Driving in Old Age
Predictive Factors Associated With Continued Driving in Old Age : a Mixed Methods Approach
The goal of this observational study is to learn about predictors associated with maintaining driving in old age. The main questions it aims to answer are :
- which and how medical factors can influence stopping or maintaining driving (quantitative research)
- how social environment can influence stopping or maintaining driving (quantitative research)
- what are the needs of all the actors in the field (qualitative research)
- know about the opinions and practices of all the actors in the field (qualitative research) Participants will be ask to answer questions in an interview taking about an hour. Quantitative research will ask participants to fill out a questionnaire about social environment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
FAMACO is a project led by Gérontopôle Auvergne Rhône-Alpes (AURA) and Chaire Santé des Ainés of the Jean Monet University, supported by the Observatoire National Interministériel de la Sécurité Routière (ONISR), that aims prevent the loss of autonomy of the elderly population by identifying predictors associated with maintaining driving in old age. This is a mixed quantitative and qualitative prospective study.
Quantitative study identify medical factors linked to stopping driving by analysis data from "PROnostic of factors OF cardiovascular or neurovascular disease" (PROOF) cohort. In addition, a questionnaire on the social environment was addressed to participants.
Qualitative study focus on identifying the expectations and needs of all concern populations : elderly divers, elderly former drivers, general practitioner, geriatrician, certified driver's license physician, law enforcement, driving instructors and emergency services. This qualitative study will be carried out on three different sites : Saint-Etienne, Marseille, and Lille.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lille, France
- François Puisieux
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Marseille, France
- Sylvie Bonin-Guillaume
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Loire
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Saint-Étienne, Loire, France, 42000
- Nathalie Barth
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria :
- being part of one of the population studied (older 65 people ; attending physicians ; law enforcement ; certified driver's license ; physicians ; geriatricians ; driving instructors ; personal assistance services)
- live in Saint-Etienne, Marseille or Lille
Exclusion criteria :
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Older 80 people
Semi-structured interviews were conducted for the qualitative research.
In addition, a driving habits questionnaire was administered.
To complete this questionnaire, medical data from the PROOF cohort were collected.The PROOF cohort is a prospective study for which enrollment began in 2001.
The main objective is to evaluate the predictive value of Autonomic Nervous System (ANS) activity and its decline during follow-up on the occurrence of serious and cerebral events, and on all-cause mortality, in a general population of subjects of homogeneous age.
Participants were included in the study if they were 65 years of age (plus or minus 2 years) at the time of inclusion and registered on the electoral list of the city of St Etienne, had not had a previous myocardial infarction or stroke and were non-insulin dependent.
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An interview guide was developed for each population.
Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
The questionnaire asks people aged 80 and over included in the PROOF cohort about their relationship to driving, their driving status, their societal and personal environment, the circumstances in which they stopped driving, recent accidents and, more generally, their driving habits.
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Attending physicians
Semi-structured interviews were conducted for the qualitative research
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An interview guide was developed for each population.
Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
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law enforcement
Semi-structured interviews were conducted for the qualitative research
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An interview guide was developed for each population.
Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
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certified driver's license physicians
Semi-structured interviews were conducted for the qualitative research
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An interview guide was developed for each population.
Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
|
|
geriatricians
Semi-structured interviews were conducted for the qualitative research
|
An interview guide was developed for each population.
Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
|
|
driving instructors
Semi-structured interviews were conducted for the qualitative research
|
An interview guide was developed for each population.
Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
|
|
personal assistance services
Semi-structured interviews were conducted for the qualitative research
|
An interview guide was developed for each population.
Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Views and representations of the different populations on the conduct of the elderly
Time Frame: Day 1
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Representations and habits of elderly driving were study by individual semi-directive interviews.
The aims is to identify, in the accounts of experiences, the practices, the relationship to driving and to other forms of transport, the lived experience, the representations of driving and ageing.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Driving habits of elderly
Time Frame: Day 1
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Habits of elderly driving were study by a questionnaire to understand the social and personal environment in relation to driving habits. The Evaluation of Precariousness and health Inequalities in health Examination Centers Score (EPICES score) was measured in this questionnaire. This individual indicator allows for the measurement of precariousness by taking into account its multidimensional nature.The questionnaire is composed of 11 questions which summarise 90% of the precariousness situation of a subject. Each question is assigned a coefficient and the sum of the answers gives the score. The score is continuous and varies from 0 (no insecurity) to 100 (maximum insecurity). The threshold of 30 is considered as the threshold of precariousness. |
Day 1
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Nathalie BARTH, PhD, Gérontopole AURA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GA-2021-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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