NCT04877028

Brief Summary

This prospective observational study will investigate the correlation 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 Clinical Frailty Scale. 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 respectively.

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 May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

May 1, 2021

Last Update Submit

June 22, 2022

Conditions

FrailtyFrailty SyndromeEmergency DepartmentGeriatric AssessmentCFS

Outcome Measures

Primary Outcomes (1)

  • Mortality in 30 days

    Investigate level of mortality in cohort at 30 days

    All cause mortality up to 90 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

  • Hospital length of stay

    Hospital length of stay from index visit, censored at 90 days

  • Revisitis to the ED

    Number of newly registered visits to the emergency department 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 genders at the age of ≥65 years seeking medical care at the three ED instances in Region Östergötland.

You may qualify if:

  • ≥65 years, able to answer any questions, alternatively have a proxy

You may not qualify if:

  • \- Patients: \<65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Linköping

Linköping, Östergötland County, 58185, Sweden

Location

Related Publications (6)

  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PMID: 16129869BACKGROUND

  • Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.

    PMID: 21093718BACKGROUND

  • Rockwood K, Theou O. Using the Clinical Frailty Scale in Allocating Scarce Health Care Resources. Can Geriatr J. 2020 Sep 1;23(3):210-215. doi: 10.5770/cgj.23.463. eCollection 2020 Sep.

    PMID: 32904824BACKGROUND

  • Wallis SJ, Wall J, Biram RW, Romero-Ortuno R. Association of the clinical frailty scale with hospital outcomes. QJM. 2015 Dec;108(12):943-9. doi: 10.1093/qjmed/hcv066. Epub 2015 Mar 15.

    PMID: 25778109BACKGROUND

  • Kaeppeli T, Rueegg M, Dreher-Hummel T, Brabrand M, Kabell-Nissen S, Carpenter CR, Bingisser R, Nickel CH. Validation of the Clinical Frailty Scale for Prediction of Thirty-Day Mortality in the Emergency Department. Ann Emerg Med. 2020 Sep;76(3):291-300. doi: 10.1016/j.annemergmed.2020.03.028. Epub 2020 Apr 24.

    PMID: 32336486BACKGROUND

  • Munir Ehrlington S, Horlin E, Toll John R, Wretborn J, Wilhelms D. Frailty is associated with 30-day mortality: a multicentre study of Swedish emergency departments. Emerg Med J. 2024 Aug 21;41(9):514-519. doi: 10.1136/emermed-2023-213444.

    PMID: 39053972DERIVED

MeSH Terms

Conditions

FrailtyEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

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 1, 2021

First Posted

May 7, 2021

Study Start

May 17, 2021

Primary Completion

November 14, 2021

Study Completion

November 14, 2021

Last Updated

June 23, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)