- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05680714
Does the New Fall- and Fracture Prevention Initiative in Oslo Have Effect?
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 years or older
- Living on Oslo, Norway in the period January 1. 2012 - December 31. 2019
Exclusion Criteria:
- Hip fracture before baseline
- Living in nursing home at baseline
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
Other Names:
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip fracture
Time Frame: 2012-2019
|
A new hip fracture registered in the Norwegian Patient registry
|
2012-2019
|
Admission to nursing home
Time Frame: 2012-2019
|
Long-term admission to nursing home
|
2012-2019
|
Death
Time Frame: 2012-2019
|
Total mortality
|
2012-2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subsequent fall injuries
Time Frame: 2012-1019
|
Subsequent falls that result in injuries registered in the Norwegian Patient Registry
|
2012-1019
|
Collaborators and Investigators
Investigators
- Study Director: Gro Idland, PhD, Municipality of Oslo, Department of Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCN296587
- 296587 (Other Grant/Funding Number: The Research Council of Norway)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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