Aged, 80 and OverNCT05872490
Predictors Associated With Maintaining Driving in Old Age
An observational study of Aged, 80 and Over, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged, 80 and Over
- What is being tested?
- Semi-structured interviews and Questionnaire
- How many people
- 657 participants
- Where
- 3 sitesFrance
- Study dates
- 5 Feb 2019to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 7 populations are included in the study: older 65 people ; attending physicians ; law enforcement ; certified driver's license ; physicians ; geriatricians ; driving instructors ; personal assistance services. For each of them, the respondents are based in one of the three investigation sites: Saint-Etienne, Lille or Marseille. For people aged 65 and over, a questionnaire is also distributed.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
France3 sites
François Puisieux
Lille
Sylvie Bonin-Guillaume
Marseille
Nathalie Barth
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42000
About this study
Official title: 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.
Read the 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.
- Conditions
- Aged, 80 and Over
- Being tested
- Semi-structured interviews, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
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.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Semi-structured interviews; Other: Questionnaire | |
| Attending physicians | Semi-structured interviews were conducted for the qualitative research Receives: Other: Semi-structured interviews | |
| law enforcement | Semi-structured interviews were conducted for the qualitative research Receives: Other: Semi-structured interviews | |
| certified driver's license physicians | Semi-structured interviews were conducted for the qualitative research Receives: Other: Semi-structured interviews | |
| geriatricians | Semi-structured interviews were conducted for the qualitative research Receives: Other: Semi-structured interviews | |
| driving instructors | Semi-structured interviews were conducted for the qualitative research Receives: Other: Semi-structured interviews | |
| personal assistance services | Semi-structured interviews were conducted for the qualitative research Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Views and representations of the different populations on the conduct of the elderly
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.
Measured: Day 1
Secondary outcomes (1)
Driving habits of elderly
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start5 Feb 2019
- Primary completion1 Mar 2019
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged, 80 and OverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Gerontopole Auvergne Rhone-Alpes (AURA), Jean Monnet University, University Hospital, Lille, Centre de Recherche Hospitalier Universitaire de Marseille
- Responsible party
- Principal investigator, Nathalie BARTH, Centre Hospitalier Universitaire de Saint Etienne
- Investigators
- Nathalie BARTH, PhD, Study chair, GERONTOPOLE AURA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872490
- Sponsor's protocol ID
- GA-2021-06
- Status last verified
- Jul 2023
- First submitted
- 10 May 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors Associated With Continued Driving in Old Age : a Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT05872490
- Acronym / sponsor ID
- GA-2021-06
- Conditions
- Aged, 80 and Over
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Gerontopole Auvergne Rhone-Alpes (AURA), Jean Monnet University, University Hospital, Lille, Centre de Recherche Hospitalier Universitaire de Marseille
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Older 80 people | – | Other: Semi-structured interviews, Other: QuestionnaireSemi-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. |
| Attending physicians | – | Other: Semi-structured interviewsSemi-structured interviews were conducted for the qualitative research |
| law enforcement | – | Other: Semi-structured interviewsSemi-structured interviews were conducted for the qualitative research |
| certified driver's license physicians | – | Other: Semi-structured interviewsSemi-structured interviews were conducted for the qualitative research |
| geriatricians | – | Other: Semi-structured interviewsSemi-structured interviews were conducted for the qualitative research |
| driving instructors | – | Other: Semi-structured interviewsSemi-structured interviews were conducted for the qualitative research |
| personal assistance services | – | Other: Semi-structured interviewsSemi-structured interviews were conducted for the qualitative research |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 7 populations are included in the study: older 65 people ; attending physicians ; law enforcement ; certified driver's license ; physicians ; geriatricians ; driving instructors ; personal assistance services. For each of them, the respondents are based in one of the three investigation sites: Saint-Etienne, Lille or Marseille. For people aged 65 and over, a questionnaire is also distributed.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsAn 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. | Other | Attending physicians, Older 80 people, certified driver's license physicians, driving instructors, geriatricians, law enforcement, personal assistance services |
| QuestionnaireThe 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. | Other | Older 80 people |
Primary outcome
Views and representations of the different populations on the conduct of the elderly
Time frame: Day 1
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.
1 secondary outcome
Driving habits of elderly
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie BARTH, PhD study chair
GERONTOPOLE AURA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged, 80 and Over, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Views and representations of the different populations on the conduct of the elderly (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.