Frailty SyndromeGr-GFINCT05091645
Translation and Cultural Adaptation of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture
An observational study of Frailty Syndrome and Hip Fractures, run by University of Thessaly at 1 site in Greece.
Trial summary
This study attempts to the translation and the cultural adaptation of the Groningen Frailty Indicator (GFI) questionnaire in the Greek population in patients suffering from hip fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty Syndrome, Hip Fractures
- What is being tested?
- GFI
- How many people
- 89 participants
- Where
- 1 siteGreece
- Study dates
- 25 Feb 2022to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with hip fractures undergoing surgery
Who may be able to join
- adult patients over 65 years old with hip fractures undergoing surgery
- an ASA (American Society of Anesthesiologists) PS (physical status) I to III
- non-institutionalized
- able to communicate orally or in writing
- consent to participate
Who cannot join
- refused to participate
- pathological hip fractures
- institutionalized
- patients with hip fracture treated conservatively
- patients with severe cognitive dysfunction
- patients with insufficient knowledge of the Greek language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University of Thessaly
Larissa, 41335
Eleni Arnaoutoglou, MD, PhD, +306974301352, earnaout@gmail.com
Maria Ntalouka, MD, PhD, +306973688099, maria.ntalouka@icloud.com
About this study
Official title: Translation and Cultural Adaptation of the Greek Version of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture; a Prospective Cohort Study
This study attempts to the translation and the cultural adaptation of the Groningen Frailty Indicator (GFI) questionnaire in the Greek population in patients suffering from hip fracture.
Read the detailed description
Frailty indicates a state of vulnerability in terms of poor health outcomes, such as mortality, hospitalization, institutionalization and loss of function in one or more domains (i.e. physical, psychological, cognitive and social domains). Frailty is not only associated with poor quality of life and life satisfaction but also has an effect on health care demands, as the number of frail people in our aging population will increase.
Current literature suggests that frailty is a common condition among elderly patients with hip fracture. Ageing has been associated with a decline in physiological reserves which impedes the body's ability to withstand and recover from minor and major challenges, such as the hip fracture. Hence, accurate diagnosis of frailty seems mandatory. The Groningen Frailty Indicator (GFI) questionnaire is a feasible, reliable and valid self-assessment tool.
This study will provide the first official Greek translation and cultural adaptation of the GFI according to the ISPOR (International Society for Pharmacoeconomics and Outcomes Research) guidelines.
- Conditions
- Frailty Syndrome, Hip Fractures
- Being tested
- GFI
- Keywords
- Frailty Syndrome, Hip fractures, Cultural adaptation, Translation
- Medical subject headings
- Frailty, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFIOther
Two trained raters who will be blinded and will have no access to each other's evaluation, will administer the GFI questionnaire within 24 hours of patients' hospital admission.
| Study group | Role | What they receive |
|---|---|---|
| Hip fracture_GFI | Greek patients with hip fracture assessed for frailty syndrome with the adapted for the greek population GFI questionnaire Receives: Other: GFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation and Cultural adaptation of the Greek version of Groningen Frailty Indicator (GFI) questionnaire
Translation and Cultural adaptation of the Greek version of GFI
Measured: Within 24 hours of the hospital admission
Secondary outcomes (1)
Incidence of frailty syndrome
Incidence of frailty syndrome in our study sample
Measured: Baseline (On admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start25 Feb 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
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.
- More trials run by University of ThessalyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, MD, PhD, Principal investigator, University of ThessalyMichael Hantes, MD, PhD, Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091645
- Sponsor's protocol ID
- Gr-Groningen Frailty Indicator
- Acronym
- Gr-GFI
- Status last verified
- May 2026
- First submitted
- 21 Oct 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Cultural Adaptation of the Greek Version of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture; a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05091645
- Acronym / sponsor ID
- Gr-GFI / Gr-Groningen Frailty Indicator
- Conditions
- Frailty Syndrome, Hip Fractures
- Keywords
- Frailty Syndrome, Hip fractures, Cultural adaptation, Translation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 25 Oct 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.
This study attempts to the translation and the cultural adaptation of the Groningen Frailty Indicator (GFI) questionnaire in the Greek population in patients suffering from hip fracture.
Detailed description
Frailty indicates a state of vulnerability in terms of poor health outcomes, such as mortality, hospitalization, institutionalization and loss of function in one or more domains (i.e. physical, psychological, cognitive and social domains). Frailty is not only associated with poor quality of life and life satisfaction but also has an effect on health care demands, as the number of frail people in our aging population will increase.
Current literature suggests that frailty is a common condition among elderly patients with hip fracture. Ageing has been associated with a decline in physiological reserves which impedes the body's ability to withstand and recover from minor and major challenges, such as the hip fracture. Hence, accurate diagnosis of frailty seems mandatory. The Groningen Frailty Indicator (GFI) questionnaire is a feasible, reliable and valid self-assessment tool.
This study will provide the first official Greek translation and cultural adaptation of the GFI according to the ISPOR (International Society for Pharmacoeconomics and Outcomes Research) guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip fracture_GFI | – | Other: GFIGreek patients with hip fracture assessed for frailty syndrome with the adapted for the greek population GFI questionnaire |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with hip fractures undergoing surgery
Key inclusion criteria (5 listed)
- adult patients over 65 years old with hip fractures undergoing surgery
- an ASA (American Society of Anesthesiologists) PS (physical status) I to III
- non-institutionalized
- able to communicate orally or in writing
- consent to participate
Key exclusion criteria (6 listed)
- refused to participate
- pathological hip fractures
- institutionalized
- patients with hip fracture treated conservatively
- patients with severe cognitive dysfunction
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 |
|---|---|---|
| GFITwo trained raters who will be blinded and will have no access to each other's evaluation, will administer the GFI questionnaire within 24 hours of patients' hospital admission. | Other | Hip fracture_GFI |
Primary outcome
Translation and Cultural adaptation of the Greek version of Groningen Frailty Indicator (GFI) questionnaire
Time frame: Within 24 hours of the hospital admission
Translation and Cultural adaptation of the Greek version of GFI
1 secondary outcome
Incidence of frailty syndrome
Time frame: Baseline (On admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- 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.
Eleni Arnaoutoglou, MD, PhD principal investigator
University of Thessaly
Michael Hantes, MD, PhD principal investigator
University of Thessaly
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 and Hip Fractures, run by University of Thessaly at 1 site in Greece.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleni Arnaoutoglou, MD, PhD (+306974301352, earnaout@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation and Cultural adaptation of the Greek version of Groningen Frailty Indicator (GFI) questionnaire (time frame: Within 24 hours of the hospital admission). 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 7 May 2026.