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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05680714
Other study ID # RCN296587
Secondary ID 296587
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date December 1, 2024

Study information

Verified date January 2023
Source Norwegian Institute of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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, 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.


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: 1. Start of intervention in Nordstrand borough is set to January 1, 2015. 2. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 121000
Est. completion date December 1, 2024
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored intervention


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Norwegian Institute of Public Health Oslo Municipality, Oslo University Hospital, University of Oslo

Outcome

Type Measure Description Time frame Safety issue
Primary Hip fracture A new hip fracture registered in the Norwegian Patient registry 2012-2019
Primary Admission to nursing home Long-term admission to nursing home 2012-2019
Primary Death Total mortality 2012-2019
Secondary Subsequent fall injuries Subsequent falls that result in injuries registered in the Norwegian Patient Registry 2012-1019
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