Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls? (FUKNO)

July 18, 2022 updated by: University Hospital, Basel, Switzerland

It is the investigators goal to identify the prevalence of underlying diseases, make disposition more rational, and establish risk stratification tools in elderly patients presenting with falls. Additionally, the outcome of standard care (clinical assessment only for disposition) will be compared with a new approach combining the standard of care with biomarker assisted disposition of elderly patients presenting with falls. Therefore the investigators are looking at the following points.

Emergency department work-up

  1. Prevalence of underlying disease
  2. Developing algorithms for initial assessment Disposition

a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b. Comparing geriatric emergency assessment to standardized disposition planning

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

587

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charité Campus Benjamin Franklin, Berlin
  • Switzerland
      • Basel, Switzerland, 4101
        • Cantonal Hospital Baselland, Bruderholz
      • Liestal, Switzerland, 4410
        • Cantonal Hospital Baselland, Liestal
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All fall patients aged 65 years and older who presented to the emergency department giving written informed consentent

Description

Inclusion Criteria:

  • All fall patients aged 65 years and older who presented to the emergency department giving written informed consent

Exclusion Criteria:

  • Patients below 65 years
  • Non-fall patients above 65 years
  • or lack of informed consent by patients or proxies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EFAB 65
Patients presenting to the emergency department with falls, above 65 years of age. Patients History will be taken as well as a blood sample
Other: Patients History
History taking and drawing of a blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 Days
Data Collection via Case Report Form
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Morbidity
Time Frame: 30 Days
Data Collection via Case Report Form
30 Days
Institutionalisation
Time Frame: 180 Days
Data Collection via interview with general practitioner
180 Days
Disposition
Time Frame: 30 Days
Data collection via case report form
30 Days
Mortality
Time Frame: 90 Days
Data Collection via Case Report Form
90 Days
Mortality
Time Frame: 180 Days
Data Collection via Case Report Form
180 Days
Mortality
Time Frame: 365 Days
Data Collection via Case Report Form
365 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Roland Bingisser, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2014

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • FUKNO_Protokoll_17-07-14

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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