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Recruiting NCT05091645

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

Observational Frailty Syndrome Hip Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GFI.
Who it may be relevant to
Registry conditions: Frailty Syndrome, Hip Fractures. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Translation and Cultural adaptation of the Greek version of Groningen Frailty Indicator (GFI) questionnaire [Time frame: Within 24 hours of the hospital admission]
Secondary outcome measures (1)
  • Incidence of frailty syndrome [Time frame: Baseline (On admission)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • University of Thessaly — Larissa

Identifiers

NCT: NCT05091645 · Gr-Groningen Frailty Indicator

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗