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

Hip Fractures Clinical Trial

— Gr-GFI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091645
• Other study ID #: Gr-Groningen Frailty Indicator
• Status: Recruiting
• Start date: February 25, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: University of Thessaly
• Contact: Eleni Arnaoutoglou, MD, PhD
• Phone: +306974301352
• Email: earnaout[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Frailty
• Frailty Syndrome
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
Greece	University of Thessaly	Larissa

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of frailty syndrome	Incidence of frailty syndrome in our study sample	Baseline (On admission)