Frail Elderly SyndromeNCT04812834
Screening of the Frailty Degree in the Emergency Department Short Stay Unit
An observational study of Frail Elderly Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Screen all those> 65 years of age admitted to the Short Stay Unit for frailty, and detect those who are potentially fragile. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2021to 24 Feb 2023
- How long will I take part?
- 12 Months
- 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
- Older adult
Study population: Patients admitted to the Short Stay Unit of a 550-bed Urban and University Tertiary Hospital
Who may be able to join
- Patients over 65 years of age admitted to the Short Stay Unit
Who cannot join
- Patients under 65 years of age admitted to the Short Stay Unit
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
About this study
Official title: Systematic Detection and Screening of the Frailty Degree in Patients Admitted to the Emergency Department Short Stay Unit
Screen all those> 65 years of age admitted to the Short Stay Unit for frailty, and detect those who are potentially fragile.
Read the detailed description
Demographic change has led to a change in the profile and age of hospitalized patients, an increase in age and in patients with multiple chronic diseases and more complex health needs is observed.
Frailty is known to impact patient health outcomes with medical and surgical procedures. Thus, frailty is correlated with a greater presence of delirium, longer stays, a greater requirement for complementary examinations, a greater presence of mortality and other post-surgical complications, more dependence, more risks derived from hospitalization, and a greater need for convalescence after discharge.
- Conditions
- Frail Elderly Syndrome
- Keywords
- elderly, frailty, short stay unit
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
To know the degree of frailty with the frail VIG index in patients admitted to the short-stay unit
The Frail Vig index ("VIG" is the spanish/catalan abbreviation for Comprehensive Geriatric Assessment) is a new, more concise Frailty index for rapid geriatric assessment, which contains 22 simple questions that assess 25 different deficits. The Frail VIG index score assesses the degree of frailty as a continuous variable. The value of the Frail VIG index is between 0 (absence of frailty) and 0.7 (severe frailty)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start24 Feb 2021
- Primary completion24 Feb 2022 (estimated)
- Study completion24 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josep JA Montiel Dacosta, PhDs, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812834
- Sponsor's protocol ID
- IIBSP-FRA-2020-74
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Searle SD, Rockwood K. What proportion of older adults in hospital are frail? Lancet. 2018 May 5;391(10132):1751-1752. doi: 10.1016/S0140-6736(18)30907-3. Epub 2018 Apr 26. No abstract available.
PubMed 29706363Amblas-Novellas J, Martori JC, Molist Brunet N, Oller R, Gomez-Batiste X, Espaulella Panicot J. [Frail-VIG index: Design and evaluation of a new frailty index based on the Comprehensive Geriatric Assessment]. Rev Esp Geriatr Gerontol. 2017 May-Jun;52(3):119-127. doi: 10.1016/j.regg.2016.09.003. Epub 2016 Oct 28. Spanish.
PubMed 28029467Amblas-Novellas J, Martori JC, Espaulella J, Oller R, Molist-Brunet N, Inzitari M, Romero-Ortuno R. Frail-VIG index: a concise frailty evaluation tool for rapid geriatric assessment. BMC Geriatr. 2018 Jan 26;18(1):29. doi: 10.1186/s12877-018-0718-2.
PubMed 29373968Chong E, Ho E, Baldevarona-Llego J, Chan M, Wu L, Tay L. Frailty and Risk of Adverse Outcomes in Hospitalized Older Adults: A Comparison of Different Frailty Measures. J Am Med Dir Assoc. 2017 Jul 1;18(7):638.e7-638.e11. doi: 10.1016/j.jamda.2017.04.011. Epub 2017 Jun 3.
PubMed 28587850Damluji AA, Forman DE, van Diepen S, Alexander KP, Page RL 2nd, Hummel SL, Menon V, Katz JN, Albert NM, Afilalo J, Cohen MG; American Heart Association Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing. Older Adults in the Cardiac Intensive Care Unit: Factoring Geriatric Syndromes in the Management, Prognosis, and Process of Care: A Scientific Statement From the American Heart Association. Circulation. 2020 Jan 14;141(2):e6-e32. doi: 10.1161/CIR.0000000000000741. Epub 2019 Dec 9.
PubMed 31813278
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Detection and Screening of the Frailty Degree in Patients Admitted to the Emergency Department Short Stay Unit
- ClinicalTrials.gov ID
- NCT04812834
- Acronym / sponsor ID
- IIBSP-FRA-2020-74
- Conditions
- Frail Elderly Syndrome
- Keywords
- elderly, frailty, short stay unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 24 Feb 2022 (estimated)
- Study completion
- 24 Feb 2023 (estimated)
- First posted
- 24 Mar 2021 (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.
Screen all those> 65 years of age admitted to the Short Stay Unit for frailty, and detect those who are potentially fragile.
Detailed description
Demographic change has led to a change in the profile and age of hospitalized patients, an increase in age and in patients with multiple chronic diseases and more complex health needs is observed.
Frailty is known to impact patient health outcomes with medical and surgical procedures. Thus, frailty is correlated with a greater presence of delirium, longer stays, a greater requirement for complementary examinations, a greater presence of mortality and other post-surgical complications, more dependence, more risks derived from hospitalization, and a greater need for convalescence after discharge.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients admitted to the Short Stay Unit of a 550-bed Urban and University Tertiary Hospital
Key inclusion criteria (1 listed)
- Patients over 65 years of age admitted to the Short Stay Unit
Key exclusion criteria (1 listed)
- Patients under 65 years of age admitted to the Short Stay Unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To know the degree of frailty with the frail VIG index in patients admitted to the short-stay unit
Time frame: 12 months
The Frail Vig index ("VIG" is the spanish/catalan abbreviation for Comprehensive Geriatric Assessment) is a new, more concise Frailty index for rapid geriatric assessment, which contains 22 simple questions that assess 25 different deficits. The Frail VIG index score assesses the degree of frailty as a continuous variable. The value of the Frail VIG index is between 0 (absence of frailty) and 0.7 (severe frailty)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Results publication: PubMed 29706363Searle SD, Rockwood K. What proportion of older adults in hospital are frail? Lancet. 2018 May 5;391(10132):1751-1752. doi: 10.1016/S0140-6736(18)30907-3. Epub 2018 Apr 26. No abstract available.
- Results publication: PubMed 28029467Amblas-Novellas J, Martori JC, Molist Brunet N, Oller R, Gomez-Batiste X, Espaulella Panicot J. [Frail-VIG index: Design and evaluation of a new frailty index based on the Comprehensive Geriatric Assessment]. Rev Esp Geriatr Gerontol. 2017 May-Jun;52(3):119-127. doi: 10.1016/j.regg.2016.09.003. Epub 2016 Oct 28. Spanish.
- Results publication: PubMed 29373968Amblas-Novellas J, Martori JC, Espaulella J, Oller R, Molist-Brunet N, Inzitari M, Romero-Ortuno R. Frail-VIG index: a concise frailty evaluation tool for rapid geriatric assessment. BMC Geriatr. 2018 Jan 26;18(1):29. doi: 10.1186/s12877-018-0718-2.
- Results publication: PubMed 28587850Chong E, Ho E, Baldevarona-Llego J, Chan M, Wu L, Tay L. Frailty and Risk of Adverse Outcomes in Hospitalized Older Adults: A Comparison of Different Frailty Measures. J Am Med Dir Assoc. 2017 Jul 1;18(7):638.e7-638.e11. doi: 10.1016/j.jamda.2017.04.011. Epub 2017 Jun 3.
- Results publication: PubMed 31813278Damluji AA, Forman DE, van Diepen S, Alexander KP, Page RL 2nd, Hummel SL, Menon V, Katz JN, Albert NM, Afilalo J, Cohen MG; American Heart Association Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing. Older Adults in the Cardiac Intensive Care Unit: Factoring Geriatric Syndromes in the Management, Prognosis, and Process of Care: A Scientific Statement From the American Heart Association. Circulation. 2020 Jan 14;141(2):e6-e32. doi: 10.1161/CIR.0000000000000741. Epub 2019 Dec 9.
- Individual participant dataSharing planned: No
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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.
Josep JA Montiel Dacosta, PhDs principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Frail Elderly Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. 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 Spain. 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?
Results are not available in the source record.
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?
To know the degree of frailty with the frail VIG index in patients admitted to the short-stay unit (time frame: 12 months). 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 NCT04812834, which also lists 5 linked publications.
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 1 Apr 2021.