Translation and Cultural Adaptation of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture (Gr-GFI)

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures; Frailty Syndrome
• Intervention / Treatment: Other: GFI

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 Type: Observational
• Enrollment (Estimated): 89

Contacts and Locations

• Study Contact: Name: Maria Ntalouka, MD, PhD, MSc; Phone Number: +306973688099; Email: maria.ntalouka@icloud.com
• Study Contact Backup: Name: Eleni Arnaoutoglou, MD, PhD; Phone Number: +306974301352; Email: earnaout@gmail.com

Study Locations

• Greece
  • Larissa, Greece, 41335
    • Recruiting
    • University of Thessaly
    • Principal Investigator: Maria Ntalouka, MD, PhD, M.Sc.
    • Principal Investigator: Fragkiskos Angelis, MD, M.Sc.
    • Principal Investigator: Michael Hantes, MD, PhD
    • Contact: Eleni Arnaoutoglou, MD, PhD; Phone Number: +306974301352; Email: earnaout@gmail.com
    • Contact: Maria Ntalouka, MD, PhD; Phone Number: +306973688099; Email: maria.ntalouka@icloud.com
    • Principal Investigator: Eleni Arnaoutoglou, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with hip fractures undergoing surgery

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hip fracture_GFI; Greek patients with hip fracture assessed for frailty syndrome with the adapted for the greek population GFI questionnaire	Other: GFI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Translation and Cultural adaptation of the Greek version of Groningen Frailty Indicator (GFI) questionnaire	Translation and Cultural adaptation of the Greek version of GFI	Within 24 hours of the hospital admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of frailty syndrome	Incidence of frailty syndrome in our study sample	Baseline (On admission)

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Principal Investigator: Eleni Arnaoutoglou, MD, PhD, University of Thessaly; Principal Investigator: Michael Hantes, MD, PhD, University of Thessaly

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hip fractures; Cultural adaptation; Translation; Frailty Syndrome
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Pathological Conditions, Signs and Symptoms; Frailty; Hip Fractures
• Other Study ID Numbers: Gr-Groningen Frailty Indicator

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No