Fall InjuryNCT05680714
Does the New Fall- and Fracture Prevention Initiative in Oslo Have Effect?
An observational study of Fall Injury and Hip Fractures, run by Norwegian Institute of Public Health.
Trial summary
The goal of this controlled before and after study is to evaluate a new patient pathway for patients 65 years and older who have suffered a fall injury. The main questions the study aims to answer are whether this preventive initiative with improved care coordination reduces risk of subsequent hip fractures… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Injury, Hip Fractures
- What is being tested?
- Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored intervention
- How many people
- 121,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Dec 2024
- How long will I take part?
- 8 Years
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Total population in Oslo 65 years or older in the period 2012 - 2019.
Who may be able to join
- 65 years or older
- Living on Oslo, Norway in the period January 1. 2012 - December 31. 2019
Who cannot join
- Hip fracture before baseline
- Living in nursing home at baseline
About this study
Official title: Does the Improved Coordination of Care for Fall- and Fracture Prevention in Oslo Have Effect on the Rate of Hip Fractures, Need of Nursing Homes or Death?
The goal of this controlled before and after study is to evaluate a new patient pathway for patients 65 years and older who have suffered a fall injury.
The main questions the study aims to answer are whether this preventive initiative with improved care coordination reduces risk of subsequent hip fractures, admittance to nursing homes or death.
Researchers will compare two boroughs in Oslo who implemented the new patient pathway with the 13 other boroughs who did not reorganize their follow-up, but continued their care as usual.
Read the detailed description
The study is an evaluation of a new patient follow-up for fall prevention in Oslo with improvement of coordination of care for elderly at risk of fall injuries.
The intervention were introduced to the boroughs of Nordstrand and Østensjø, which are compared to the other 13 boroughs of Oslo in this controlled before and after study.
THE COHORT
All persons 65 years and older in Oslo are included in Oslo Fall Cohort and we follow all cohort participants prospectively.
OUTCOME VARIABLES
- Hip fracture
- Long term admittance to nursing home
- Death
TIMELINE
The investigators have defined the following dates as the start of intervention:
- Start of intervention in Nordstrand borough is set to January 1, 2015.
- Start of intervention Østensjø borough is set to September 1, 2016.
In the main analysis, fallers from the two intervention boroughs, Nordstrand and Østensjø, will be compared with fallers from the control boroughs during the intervention. Any differences between the intervention and control boroughs before the intervention started will be taken into account.
Data on all participants are available from 2010, and the participants will be followed from January 2012 until December 2019.
For each analysis, persons with a hip fracture or living in a nursing home at baseline will be excluded.
The analysis in the evaluation is based on registry data and no analysis relating the intervention to the outcomes has been done before registration in clinicaltrials.gov.
- Conditions
- Fall Injury, Hip Fractures
- Being tested
- Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored intervention
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored interventionOther
Also called Needs assessment and user involvement, Casefinding with identifying high risk individuals, Single point of entry to care in the boroughs, Cross sectoral plan for follow-up with role clarification
| Study group | Role | What they receive |
|---|---|---|
| FALLERS IN THE INTERVENTION BOROUGHS | Fallers 65+ years from the borough of Nordstrand from January 1. 2015 Fallers 65+ years from the borough of Østensjø from September 1. 2016
Fall injury will be included as a time-varying exposure variable. The individuals are all registered as non-fallers until they are registered with a fall injury in the NPR database, when they shift status to fallers. Receives: Other: Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored intervention | |
| FALLERS IN THE CONTROL BOROUGHS | Fallers 65+ years from all the 13 other boroughs of Oslo. Fall injury will be included as a time-varying exposure variable. The individuals are all registered as non-fallers until they are registered with a fall injury in the NPR database, when they shift status to fallers. | |
| NON-FALLERS | All non-fallers 65+ years from all Oslo boroughs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip fracture
A new hip fracture registered in the Norwegian Patient registry
Measured: 2012-2019
Admission to nursing home
Long-term admission to nursing home
Measured: 2012-2019
Death
Total mortality
Measured: 2012-2019
Secondary outcomes (1)
Subsequent fall injuries
Subsequent falls that result in injuries registered in the Norwegian Patient Registry
Measured: 2012-1019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2019
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 121,000 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- University of Oslo, Oslo University Hospital, Oslo Municipality
- Responsible party
- Principal investigator, Haakon Eduard Meyer, Norwegian Institute of Public Health
- Investigators
- Gro Idland, PhD, Study director, Municipality of Oslo, Department of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680714
- Sponsor's protocol ID
- RCN296587
- Other IDs
- 296587
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Improved Coordination of Care for Fall- and Fracture Prevention in Oslo Have Effect on the Rate of Hip Fractures, Need of Nursing Homes or Death?
- ClinicalTrials.gov ID
- NCT05680714
- Acronym / sponsor ID
- RCN296587
- Conditions
- Fall Injury, Hip Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 121,000 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- University of Oslo, Oslo University Hospital, Oslo Municipality
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 Jan 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 controlled before and after study is to evaluate a new patient pathway for patients 65 years and older who have suffered a fall injury.
The main questions the study aims to answer are whether this preventive initiative with improved care coordination reduces risk of subsequent hip fractures, admittance to nursing homes or death.
Researchers will compare two boroughs in Oslo who implemented the new patient pathway with the 13 other boroughs who did not reorganize their follow-up, but continued their care as usual.
Detailed description
The study is an evaluation of a new patient follow-up for fall prevention in Oslo with improvement of coordination of care for elderly at risk of fall injuries.
The intervention were introduced to the boroughs of Nordstrand and Østensjø, which are compared to the other 13 boroughs of Oslo in this controlled before and after study.
THE COHORT
All persons 65 years and older in Oslo are included in Oslo Fall Cohort and we follow all cohort participants prospectively.
OUTCOME VARIABLES
- Hip fracture
- Long term admittance to nursing home
- Death
TIMELINE
The investigators have defined the following dates as the start of intervention:
- Start of intervention in Nordstrand borough is set to January 1, 2015.
- Start of intervention Østensjø borough is set to September 1, 2016.
In the main analysis, fallers from the two intervention boroughs, Nordstrand and Østensjø, will be compared with fallers from the control boroughs during the intervention. Any differences between the intervention and control boroughs before the intervention started will be taken into account.
Data on all participants are available from 2010, and the participants will be followed from January 2012 until December 2019.
For each analysis, persons with a hip fracture or living in a nursing home at baseline will be excluded.
The analysis in the evaluation is based on registry data and no analysis relating the intervention to the outcomes has been done before registration in clinicaltrials.gov.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FALLERS IN THE INTERVENTION BOROUGHS | – | Other: Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored interventionFallers 65+ years from the borough of Nordstrand from January 1. 2015 Fallers 65+ years from the borough of Østensjø from September 1. 2016 Fall injury will be included as a time-varying exposure variable. The individuals are all registered as non-fallers until they are registered with a fall injury in the NPR database, when they shift status to fallers. |
| FALLERS IN THE CONTROL BOROUGHS | – | –Fallers 65+ years from all the 13 other boroughs of Oslo. Fall injury will be included as a time-varying exposure variable. The individuals are all registered as non-fallers until they are registered with a fall injury in the NPR database, when they shift status to fallers. |
| NON-FALLERS | – | –All non-fallers 65+ years from all Oslo boroughs. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Total population in Oslo 65 years or older in the period 2012 - 2019.
Key inclusion criteria (2 listed)
- 65 years or older
- Living on Oslo, Norway in the period January 1. 2012 - December 31. 2019
Key exclusion criteria (2 listed)
- Hip fracture before baseline
- Living in nursing home at baseline
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 |
|---|---|---|
| Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored interventionAlso: Needs assessment and user involvement, Casefinding with identifying high risk individuals, Single point of entry to care in the boroughs, Cross sectoral plan for follow-up with role clarification | Other | FALLERS IN THE INTERVENTION BOROUGHS |
Primary outcome
Hip fracture
Time frame: 2012-2019
A new hip fracture registered in the Norwegian Patient registry
Admission to nursing home
Time frame: 2012-2019
Long-term admission to nursing home
Death
Time frame: 2012-2019
Total mortality
1 secondary outcome
Subsequent fall injuries
Time frame: 2012-1019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Gro Idland, PhD study director
Municipality of Oslo, Department of Health
Questions about this trial
What is this clinical trial studying?
An observational study of Fall Injury and Hip Fractures, run by Norwegian Institute of Public Health.
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 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Hip fracture (time frame: 2012-2019). The study lists 3 primary outcomes in all. 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 11 Jan 2023.