Clinical trial NCT05091645: Translation and Cultural Adaptation of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty Syndrome
Hip Fractures
Keywords: Frailty Syndrome
Hip fractures
Cultural adaptation
Translation
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 89
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hip fractures undergoing surgery

Brief 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.

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.

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

Primary outcomes:
measure: Translation and Cultural adaptation of the Greek version of Groningen Frailty Indicator (GFI) questionnaire
timeFrame: Within 24 hours of the hospital admission
Secondary outcomes:
measure: Incidence of frailty syndrome
timeFrame: Baseline (On admission)
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutoglou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: Michael Hantes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: