NCT05872490

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
657

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2019

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

24 days

First QC Date

May 10, 2023

Last Update Submit

July 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (1)

  • Driving habits of elderly

    Day 1

Study Arms (7)

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.

Other: Semi-structured interviewsOther: Questionnaire

Attending physicians

Semi-structured interviews were conducted for the qualitative research

Other: Semi-structured interviews

law enforcement

Semi-structured interviews were conducted for the qualitative research

Other: Semi-structured interviews

certified driver's license physicians

Semi-structured interviews were conducted for the qualitative research

Other: Semi-structured interviews

geriatricians

Semi-structured interviews were conducted for the qualitative research

Other: Semi-structured interviews

driving instructors

Semi-structured interviews were conducted for the qualitative research

Other: Semi-structured interviews

personal assistance services

Semi-structured interviews were conducted for the qualitative research

Other: Semi-structured interviews

Interventions

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.

Attending physiciansOlder 80 peoplecertified driver's license physiciansdriving instructorsgeriatricianslaw enforcementpersonal assistance services

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.

Older 80 people

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nathalie Barth

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42000, France

Location

François Puisieux

Lille, France

Location

Sylvie Bonin-Guillaume

Marseille, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nathalie BARTH, PhD

    GERONTOPOLE AURA

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project leader, Sociologist

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 24, 2023

Study Start

February 5, 2019

Primary Completion

March 1, 2019

Study Completion

March 1, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations