Brief Description of the Focus of the Study: Number of Injuries to Bicyclists and Micro Mobility UsersNCT06710054
Recording Cyclist Crashes and Long-term Injury Consequences by New Smart Tools
An observational study of Brief Description of the Focus of the Study: Number of Injuries to Bicyclists and Micro Mobility Users, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Recording Cyclist Crashes and Long-term Injury Consequences by new Smart Tools Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brief Description of the Focus of the Study: Number of Injuries to Bicyclists and Micro Mobility Users
- How many people
- 322 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2022to 30 Sep 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cyclists with recent accident in our well defined region
Who may be able to join
- All cyclist (including micromobility devices), with recent accidents submitted to out- and in patient clinics in a well defined region of 310 000 inhabitants
Who cannot join
- No informed consent
- "Patients" not eligible for follow up within our region
Trial locations and contacts
1 site in 1 country.
About this study
Recording Cyclist Crashes and Long-term Injury Consequences by new Smart Tools
Read the detailed description
The ReCyCLIST project is a collaboration between research institutes from the health and transport sciences, public authorities, medical expertise and web-tool developers, and end-user organisations, and as such an excellent example of a project that promotes and supports cooperation between research groups and users of the research.
Three major research questions are addressed in the ReCyCLIST project:
- What are the numbers, characteristics and locations of accidents and injuries among cyclists and e-scooter/micro mobility device users in a representative county (Agder) in Norway?
- What are the consequences of injuries in terms of social and individual costs including long-term consequences with respect to recovery, disability rates etc.?
- What are the overall health impacts of cycling, when including the more comprehensive set of positive and negative effects; and what are the economic impacts from increased cycling (in terms of cost-benefit ratios)? To answer these research questions, the investigators will develop a new digital registration tool to record accidents and injuries among cyclists and users of micro mobility devices in Agder county in Norway. Patients will be followed up and data on medical rehabilitation, recovery and general conditions will be collected by use of questionnaires after three and twelve months. To map long-term consequences of injuries (> 1 year), a retrospective study will be applied based on linking data from different registers containing information about health, welfare benefits and injuries.
- Keywords
- bicyclist injuries bicyclist accidents
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recover
Time to recover
Measured: From the inclusion of bicycle accidents to 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jun 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brief Description of the Focus of the Study: Number of Injuries to Bicyclists and Micro Mobility UsersStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Odd Mjåland, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710054
- Sponsor's protocol ID
- ReCyclist
- Status last verified
- Jun 2022
- First submitted
- 19 May 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording Cyclist Crashes and Long-term Injury Consequences by New Smart Tools
- ClinicalTrials.gov ID
- NCT06710054
- Acronym / sponsor ID
- ReCyclist
- Keywords
- bicyclist injuries bicyclist accidents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Nov 2024 (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.
Recording Cyclist Crashes and Long-term Injury Consequences by new Smart Tools
Detailed description
The ReCyCLIST project is a collaboration between research institutes from the health and transport sciences, public authorities, medical expertise and web-tool developers, and end-user organisations, and as such an excellent example of a project that promotes and supports cooperation between research groups and users of the research.
Three major research questions are addressed in the ReCyCLIST project:
- What are the numbers, characteristics and locations of accidents and injuries among cyclists and e-scooter/micro mobility device users in a representative county (Agder) in Norway?
- What are the consequences of injuries in terms of social and individual costs including long-term consequences with respect to recovery, disability rates etc.?
- What are the overall health impacts of cycling, when including the more comprehensive set of positive and negative effects; and what are the economic impacts from increased cycling (in terms of cost-benefit ratios)? To answer these research questions, the investigators will develop a new digital registration tool to record accidents and injuries among cyclists and users of micro mobility devices in Agder county in Norway. Patients will be followed up and data on medical rehabilitation, recovery and general conditions will be collected by use of questionnaires after three and twelve months. To map long-term consequences of injuries (> 1 year), a retrospective study will be applied based on linking data from different registers containing information about health, welfare benefits and injuries.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cyclists with recent accident in our well defined region
Key inclusion criteria (1 listed)
- All cyclist (including micromobility devices), with recent accidents submitted to out- and in patient clinics in a well defined region of 310 000 inhabitants
Key exclusion criteria (2 listed)
- No informed consent
- "Patients" not eligible for follow up within our region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to recover
Time frame: From the inclusion of bicycle accidents to 12 months after the inclusion
Time to recover
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 29 Nov 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brief Description of the Focus of the Study: Number of Injuries to Bicyclists and Micro Mobility Users, run by Sorlandet Hospital HF at 1 site in Norway.
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 1 inclusion and 2 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Time to recover (time frame: From the inclusion of bicycle accidents to 12 months after the inclusion). 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 29 Nov 2024.