Frailty in AgingNCT06621290
Patient Experience of CFS-assessment in the ED
An observational study of Frailty in Aging and Emergency Department Visit, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty in Aging, Emergency Department Visit, Patient Experience
- What is being tested?
- Semi-structured interviews
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2024to 5 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over the age of 65, and staff in the ED
Who may be able to join
- 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.
Who cannot join
- Patients who lack cognitive capacity to give informed consent, or have an acute medical condition will be excluded from the study. Exclusion will also apply to patients who do not speak Swedish and where an interpreter cannot be arranged (the patients next of kin will not be used as an interpreter).
- Exclusion criteria for staff will be unwillingness to give informed consent.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of emergency medicine, Linköping University Hospital, Region Östergötland, Linköping
Linköping, Sweden, 58225
About this study
Official title: Understanding the Patient Experience of Geriatric Assessment in the Emergency Department
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.
Read more
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?
Read the detailed description
With the nature of qualitative data, a definitive sample size cannot be determined in advance. An estimate is that data will need to be collected for 15-25 patients. The analysis is planned to start in parallel with the data collection, and when no further significant findings are made during the progress of the analysis, the data collection will end. To ensure study quality, a reflexive approach and data-/researcher triangulation will be applyed.
- Being tested
- Semi-structured interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
Also called Qualitative research
Semi-structured interviews on ED-patients experiences of frailty assessment with the CFS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the CFS-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start30 Sep 2024
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty in AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Wilhelms, University Hospital, Linkoeping
- Investigators
- Daniel Wilhelms, PhD, MD, Principal investigator, Department of Emergency Medicine in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621290
- Sponsor's protocol ID
- 2024-03729-01
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pseudonymized data may be shared upon request
Publications
Horlin E, Ekermo D, Wilhelms D, Eldh AC. Being screened for frailty in the emergency department: the voice of patients in an exploratory qualitative study. BMC Geriatr. 2026 Jan 16;26(1):144. doi: 10.1186/s12877-026-06990-1.
PubMed 41540358
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Patient Experience of Geriatric Assessment in the Emergency Department
- ClinicalTrials.gov ID
- NCT06621290
- Acronym / sponsor ID
- 2024-03729-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
With the nature of qualitative data, a definitive sample size cannot be determined in advance. An estimate is that data will need to be collected for 15-25 patients. The analysis is planned to start in parallel with the data collection, and when no further significant findings are made during the progress of the analysis, the data collection will end. To ensure study quality, a reflexive approach and data-/researcher triangulation will be applyed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients over the age of 65 visiting the ED | – | Other: Semi-structured interviewsPatients 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over the age of 65, and staff in the ED
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who lack cognitive capacity to give informed consent, or have an acute medical condition will be excluded from the study. Exclusion will also apply to patients who do not speak Swedish and where an interpreter cannot be arranged (the patients next of kin will not be used as an interpreter).
- Exclusion criteria for staff will be unwillingness to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsAlso: Qualitative researchSemi-structured interviews on ED-patients experiences of frailty assessment with the CFS | Other | Patients over the age of 65 visiting the ED |
Primary outcome
The patient experience of participating in a frailty assessment with the CFS
Time frame: immediately after the CFS-assessment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 41540358Horlin E, Ekermo D, Wilhelms D, Eldh AC. Being screened for frailty in the emergency department: the voice of patients in an exploratory qualitative study. BMC Geriatr. 2026 Jan 16;26(1):144. doi: 10.1186/s12877-026-06990-1.
- Individual participant dataSharing planned: Undecided. Pseudonymized data may be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Wilhelms, PhD, MD principal investigator
Department of Emergency Medicine in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty in Aging and Emergency Department Visit, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient experience of participating in a frailty assessment with the CFS (time frame: immediately after the CFS-assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06621290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.