Frailty SyndromeNCT04830865
Adaptation and Validation of Frailty Scales in Intensive Care Units in Spain
An observational study of Frailty Syndrome, run by Hospital Universitario Getafe at 1 site in Spain.
Trial summary
Increased life expectancy leads to population aging, increased morbidities and aging of hospitalized patients. The acquisition of frailty leads to worse outcomes derived from hospitalization, but although frailty has been related to aging, young patients admitted to Intensive Care Units (ICU) with frailty have also… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty Syndrome
- How many people
- 512 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2019to 5 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who remain hospitalized for more than 48 hours in any of the 8 Spanish intensive care units participating in the study, they will be candidates for inclusion in the study.
Who may be able to join
- Critical care patients over 18 years who have given their consent personally.
Who cannot join
- Patients admitted with a diagnosis of present or imminent brain death,
- readmissions previously included,
- patients whose expected stay is less than 48 hours
- patients with comunication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Validation of Frailty Scales in Critically Ill Patients Admitted to Intensive Care Units in Spain
Increased life expectancy leads to population aging, increased morbidities and aging of hospitalized patients. The acquisition of frailty leads to worse outcomes derived from hospitalization, but although frailty has been related to aging, young patients admitted to Intensive Care Units (ICU) with frailty have also been found to have worse outcomes than non-frail patients. This unfavorable evolution could be related to the acquisition of the post-uci syndrome (physical, mental and cognitive sequelae at discharge from the ICU), since high frailty scores favor this syndrome.
The use of frailty scales on admission to the ICU could provide early detection of patients most likely to develop post-ICU syndrome, regardless of age, and redirect our care to those who need it most. Some scales that measure frailty in elderly patients have been used in the ICU, but although they have been validated in their original language, they need to be adapted and validated in Spanish.
Read more
Objectives. Adaptation and validation of the Clinical Frailty Scale (CFS) and the FRAIL Scale in ICU patients of different ages, in women and in men.
Methodology. Study developed in two phases.Phase 1, adaptation to Spanish of the scales (translation, pilot, back-translation, correlation); Phase 2, analysis of their metric properties (Validity, Reliability, Sensitivity, Minimum important difference) by means of a multicenter observational study (7 ICUs in Spain), prospective, descriptive, of a cohort of critical patients with one-year follow-up (at 3, 6, 9 and 12 months after hospital discharge).
- Conditions
- Frailty Syndrome
- Keywords
- Frailty, critical care, gender, reliability, validity, study transcultural, quality of life
- Medical subject headings
- Frailty, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Fragility scales's validation
100% scale sensitivity
Measured: 2 years
Secondary outcomes (6)
Obtaining adapted scales to patients in intensive care units in Spain
Through a process of cross-cultural, FRAIL scale will be implemented in spanish. Minimun value is 0 and maximum value is 5. Value of 0 is not frail, values of 1 or 2 is prefrail and values of 3 to 5 is frail.
Measured: 6 months
Obtaining adapted scales to patients in intensive care units in Spain
Through a process of cross-cultural adaptation, Clinical Frailty Scale (CFS) will be implemented in spanish. Minimun value is 0 and maximum value is 9. Values of 0 to 3 is not frail, values of 4 is vulnerable, and 5 or 9 is frail.
Measured: 6 months
Assessment of the predictive, convergent and divergent validity of the scales obtained (with respect to the original ones)
Using statistical tests, the validity of the scales will be estimated in relation to the variables which it should or should not have concordance and its predictive capacity.
Measured: 2 years
Assessment of the interobserver and intraobserver reliability of the scales obtained (with respect to the original ones)
Through statistical tests, the interobserver and intraobserver concordance between nurses and physicians will be estimated.
Measured: 2 years
Assessment of the sensitivity to change of the scales obtained (with respect to the original ones)
Through statistical tests, the floor and ceiling of the scales and the change in the score of the scales obtained between baseline and 3, 6, 9 and 12 months after hospital discharge will be assessed.
Measured: 1 year
Assessment of the minimum important difference of the scales obtained
The relevance of the change in the score on the scales will be assessed, from the point of view of the patient and the professionals, related to quality of life.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start15 Sep 2019
- Primary completion5 Oct 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 512 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Susana Arias Rivera, Hospital Universitario Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830865
- Sponsor's protocol ID
- PI20/01231
- Other IDs
- CEIM19/42
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of Frailty Scales in Critically Ill Patients Admitted to Intensive Care Units in Spain
- ClinicalTrials.gov ID
- NCT04830865
- Acronym / sponsor ID
- PI20/01231
- Conditions
- Frailty Syndrome
- Keywords
- Frailty, critical care, gender, reliability, validity, study transcultural, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 5 Apr 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.
Increased life expectancy leads to population aging, increased morbidities and aging of hospitalized patients. The acquisition of frailty leads to worse outcomes derived from hospitalization, but although frailty has been related to aging, young patients admitted to Intensive Care Units (ICU) with frailty have also been found to have worse outcomes than non-frail patients. This unfavorable evolution could be related to the acquisition of the post-uci syndrome (physical, mental and cognitive sequelae at discharge from the ICU), since high frailty scores favor this syndrome.
The use of frailty scales on admission to the ICU could provide early detection of patients most likely to develop post-ICU syndrome, regardless of age, and redirect our care to those who need it most. Some scales that measure frailty in elderly patients have been used in the ICU, but although they have been validated in their original language, they need to be adapted and validated in Spanish.
Objectives. Adaptation and validation of the Clinical Frailty Scale (CFS) and the FRAIL Scale in ICU patients of different ages, in women and in men.
Methodology. Study developed in two phases.Phase 1, adaptation to Spanish of the scales (translation, pilot, back-translation, correlation); Phase 2, analysis of their metric properties (Validity, Reliability, Sensitivity, Minimum important difference) by means of a multicenter observational study (7 ICUs in Spain), prospective, descriptive, of a cohort of critical patients with one-year follow-up (at 3, 6, 9 and 12 months after hospital discharge).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who remain hospitalized for more than 48 hours in any of the 8 Spanish intensive care units participating in the study, they will be candidates for inclusion in the study.
Key inclusion criteria (1 listed)
- Critical care patients over 18 years who have given their consent personally.
Key exclusion criteria (4 listed)
- Patients admitted with a diagnosis of present or imminent brain death,
- readmissions previously included,
- patients whose expected stay is less than 48 hours
- patients with comunication problems
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
Fragility scales's validation
Time frame: 2 years
100% scale sensitivity
6 secondary outcomes
Obtaining adapted scales to patients in intensive care units in Spain
Time frame: 6 months
Obtaining adapted scales to patients in intensive care units in Spain
Time frame: 6 months
Assessment of the predictive, convergent and divergent validity of the scales obtained (with respect to the original ones)
Time frame: 2 years
Assessment of the interobserver and intraobserver reliability of the scales obtained (with respect to the original ones)
Time frame: 2 years
Assessment of the sensitivity to change of the scales obtained (with respect to the original ones)
Time frame: 1 year
Assessment of the minimum important difference of the scales obtained
Time frame: 2 years
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 13 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syndrome, run by Hospital Universitario Getafe 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 4 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 13 Mar 2025. 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?
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?
Fragility scales's validation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2025.