NCT04888884

Brief Summary

This prospective observational study will investigate the correlation of a surrogate marker of frailty in relation to serious outcomes. Serious outcomes are defined as: mortality within 30 days, admission to hospital, length of stay in the Emergency Department (ED), in-hospital Length of Stay and revisits to the ED. The exposure, frailty, will be assessed according to Loss of Independence (LOI) a possible low-cost quick tool to identify frailty in patients. The study population will be ED patients, \>65 years of age in a Swedish regional health care system (Region Östergötland, Sweden), comprising three EDs in Linköping, Norrköping and Motala. The outcomes will be compared according to the degree of frailty and censored over 7, 30 and 90 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 11, 2021

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality in 30 Days

    Investigate level of mortality in cohort at 30 days

    All cause mortality up to 30 days from index visit

Secondary Outcomes (7)

  • Mortality in 7 and 90 days

    All cause mortality up to 90 days from index visit

  • Admission to hospital

    Hospital admission on index visit, censored at 90 days

  • ED length of stay

    Length of stay at ED, censored at 4 days

  • In-hospital length of stay

    In-hospital length of stay from index visit, censored at 90 days

  • Revisits to the ED

    Number of newly registered visits to the ED after index visit, censored at 90 days

  • +2 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of all gender at the age of ≥ 65 years seeking medical care at the three EDs in Region Östergötland.

You may qualify if:

  • ≥ 65 years
  • able to answer questions to estimate frailty
  • or have a proxy to answer questions

You may not qualify if:

  • \<65 years
  • unable to answer questions to estimate frailty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Linköping

Linköping, Östergötland County, 58185, Sweden

Location

Medicinska Specialist Kliniken i Motala

Motala, Östergötland County, Sweden

Location

Vrinnevisjukhuset i Norrköping

Norrköping, Östergötland County, Sweden

Location

Related Publications (6)

  • Kellett J, Deane B. The Simple Clinical Score predicts mortality for 30 days after admission to an acute medical unit. QJM. 2006 Nov;99(11):771-81. doi: 10.1093/qjmed/hcl112. Epub 2006 Oct 17.

    PMID: 17046859BACKGROUND
  • Kellett J, Deane B, Gleeson M. Derivation and validation of a score based on Hypotension, Oxygen saturation, low Temperature, ECG changes and Loss of independence (HOTEL) that predicts early mortality between 15 min and 24 h after admission to an acute medical unit. Resuscitation. 2008 Jul;78(1):52-8. doi: 10.1016/j.resuscitation.2008.02.011. Epub 2008 Apr 10.

    PMID: 18406038BACKGROUND
  • Brabrand M, Folkestad L, Clausen NG, Knudsen T, Hallas J. Risk scoring systems for adults admitted to the emergency department: a systematic review. Scand J Trauma Resusc Emerg Med. 2010 Feb 11;18:8. doi: 10.1186/1757-7241-18-8.

    PMID: 20146829BACKGROUND
  • Brabrand M, Lassen AT, Knudsen T, Hallas J. Seven-day mortality can be predicted in medical patients by blood pressure, age, respiratory rate, loss of independence, and peripheral oxygen saturation (the PARIS score): a prospective cohort study with external validation. PLoS One. 2015 Apr 13;10(4):e0122480. doi: 10.1371/journal.pone.0122480. eCollection 2015.

    PMID: 25867881BACKGROUND
  • Rylance J, Baker T, Mushi E, Mashaga D. Use of an early warning score and ability to walk predicts mortality in medical patients admitted to hospitals in Tanzania. Trans R Soc Trop Med Hyg. 2009 Aug;103(8):790-4. doi: 10.1016/j.trstmh.2009.05.004. Epub 2009 Jun 21.

    PMID: 19540542BACKGROUND
  • Berian JR, Mohanty S, Ko CY, Rosenthal RA, Robinson TN. Association of Loss of Independence With Readmission and Death After Discharge in Older Patients After Surgical Procedures. JAMA Surg. 2016 Sep 21;151(9):e161689. doi: 10.1001/jamasurg.2016.1689. Epub 2016 Sep 21.

    PMID: 27409710BACKGROUND

MeSH Terms

Conditions

FrailtyEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Daniel Wilhelms, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 17, 2021

Study Start

September 27, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations