NCT06621290

Brief Summary

An increasingly common subject of interest among emergency care research is frailty, which is commonly described as a decline in several inter-related physiological systems, in addition to an increased vulnerability to stressors. To increase emergency care staffs ability to intervene appropriately in patients who need interventions to improve their outcomes, geriatric emergency care guidelines include recommendations to identify frailty during the emergency department (ED) visit. However, the patients´ experience of frailty assessment in general is sparsely investigated, and such studies within the ED context are even more limited. It is conceivable that the patients experience of a frailty assessment may differ depending on several different factors, including which assessment tool is used. A large number of assessment tools have been developed to help identify frailty, of which the Clinical Frailty Scale (CFS) is one of the most widely used. The CFS has been validated for persons ≥65 years of age and has been evaluated for validity, reliability and feasibility in an ED-setting. The CFS consists of pictograms combined with clinical descriptions of a persons level of functioning in daily life and cognitive status. Hence, to determine the CFS-score, the healthcare staff needs to ask the patient about their physical activity and function level regarding instrumental and personal activities of daily living (eg, banking, shopping, medication management, housekeeping, dressing and hygiene matters). Since the different questions are often not directly linked to the patients acute illness, but touch on personal subjects like the persons abilities and life situation, it is desirable to understand the patients experience of such an assessment in order to optimise the approach from a patient perspective. To the best of our knowledge, there are no studies that focus on how patients experience being assessed with CFS during their ED-visit. The aim of this study is therefore to inform a model to guide emergency department staff in assessing frailty with CFS, directed by the perspective from patients along the frailty trajectory. Specifically, our question is: \- How do older ED-patients experience the frailty assessment with the CFS?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

September 19, 2024

Last Update Submit

November 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The patient experience of participating in a frailty assessment with the CFS

    Qualitative method, conducted in the form of video recordings of the CFS-assessments and individual semi-structured interviews. The planned method of analysis is Thematic Analysis.

    immediately after the CFS-assessment

Study Arms (1)

Patients over the age of 65 visiting the ED

Patients over the age of 65 visiting the ED who is capable of giving informed consent and who are planned to participate in a frailty assessment

Other: Semi-structured interviews

Interventions

Semi-structured interviews on ED-patients experiences of frailty assessment with the CFS

Also known as: Qualitative research
Patients over the age of 65 visiting the ED

Eligibility Criteria

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

Patients over the age of 65, and staff in the ED

You may qualify if:

  • Patients aged ≥ 65 years attending the ED, and who gives informed consent to participating in the study.
  • Emergency department staff will be included if they are to perform a CFS assessment on a patient eligible for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of emergency medicine, Linköping University Hospital, Region Östergötland, Linköping

Linköping, Sweden, 58225, Sweden

Location

Study Officials

  • Daniel Wilhelms, PhD, MD

    Department of Emergency Medicine in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 19, 2024

First Posted

October 1, 2024

Study Start

September 30, 2024

Primary Completion

November 5, 2024

Study Completion

November 5, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations