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CompletedNCT04877028Updated Jun 23, 2022

Frailty Screening in the Swedish Emergency Department Setting

An observational study in Frailty, Frailty Syndrome and Emergency Department, sponsored by University Hospital, Linkoeping. Completed at 1 site in Sweden. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.

Sponsored by University Hospital, Linkoeping · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,800
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality.

The clinical frailty scale (CFS) is a measure of frailty based on clinical judgement in a 9 level scale, categorized as "vulnerable" (1-4), "mildly frail" (5), moderatly frail (6) and severely and very severely frail (7-8).". A validation study of the CFS in community-dwelling older people showed that it performed better than measures of cognition, function or comorbidity in assessing risk for death. In a prospective observational study including consecutive ED patients aged 65 years or older The Hosmer-Lemeshow test indicated a good agreement between predicted probability and observed frequency of 30-day mortality and ICU admission.

The aim of this study will be to investigate if the fraily, assessed according to CFS, is associated with increased 30-day mortality. in a Swedish Emergency Care context. Secondary outcomes included 7-and 90-day mortality, ED length of stay, hospital admission, hospital length of stay, subsequent falls and medication changes. Additionally, we collect data on morbidity and comorbidities to assess the association with the level of frailty. Since this is a multicenter study, possible geographic differences will be studied as well. Based on the results of this study, possible interventions could be identified to improve the care of the frail geriatric patients presenting at the ED.

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Conditions studied

  • Frailty
  • Frailty Syndrome
  • Emergency Department
  • Geriatric Assessment
  • CFS
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 1,800 is above the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients: \<65 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,800 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality in 30 days

    Investigate level of mortality in cohort at 30 days

    Time frame: All cause mortality up to 90 days from index visit

Secondary outcomes

  1. Mortality in 7 and 90 days

    Investigate level of mortality in cohort at 7 and 90 days

    Time frame: All cause mortality up to 90 days from index visit

  2. Admission to hospital

    Investigate level of all cause admissions in cohort

    Time frame: Hospital admission on index visit, censored at 90 days

  3. ED length of stay

    Investigate length of stay at ED

    Time frame: Length of stay at ED, censored at 4 days

  4. Hospital length of stay

    Investigate hospital length of stay

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

  5. Revisitis to the ED

    Number of newly registered visits to the emergency department after index visit

    Time frame: Number of newly registered visits to the emergency department after index visit, censored at 90 days

  6. Fall prevalence after the index visit

    Falls that resulted in further ED visits

    Time frame: Falls that resulted in further ED visits after index visit, censored in 90 days

  7. Alterations in medication during the visit (based on codes for Anatomical, Therapeutic, Chemical classification (ATC-code))

    Alterations in medication and during the follow-up period

    Time frame: Alterations in medications from index visit and during the follow-up period, censored at 90 days

07

Study locations

1 site
  • University Hospital Linköping
    Linköping, Östergötland 58185, Sweden
08

References and documents

Publications

  • 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. PubMed 16129869 ↗
  • 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. PubMed 21093718 ↗
  • 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. PubMed 32904824 ↗
  • 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. PubMed 25778109 ↗
  • 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. PubMed 32336486 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04877028
Lead sponsor
University Hospital, Linkoeping
Responsible party
Daniel Wilhelms (Principal Investigator, University Hospital, Linkoeping) — Principal investigator
First posted
May 7, 2021
Start date
May 17, 2021
Primary completion
Nov 14, 2021
Completion
Nov 14, 2021
Last update
Jun 23, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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