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

Sponsor

University of Thessaly (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05091645

Collaborator

(none)

Enrollment

Location

9.1

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Syndrome Hip Fractures	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 Design

Study Type:

Observational

Anticipated Enrollment :

89 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Feb 25, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Translation and Cultural adaptation of the Greek version of Groningen Frailty Indicator (GFI) questionnaire [Within 24 hours of the hospital admission]
Translation and Cultural adaptation of the Greek version of GFI

Secondary Outcome Measures

Incidence of frailty syndrome [Baseline (On admission)]
Incidence of frailty syndrome in our study sample

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Thessaly	Larissa		Greece	41335

Sponsors and Collaborators

University of Thessaly

Investigators

Principal Investigator: Eleni Arnaoutoglou, MD, PhD, University of Thessaly
Principal Investigator: Michael Hantes, MD, PhD, University of Thessaly

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly

ClinicalTrials.gov Identifier:

NCT05091645

Other Study ID Numbers:

Gr-Groningen Frailty Indicator

First Posted:

Oct 25, 2021

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly

Additional relevant MeSH terms:

Frailty

Fractures, Bone

Hip Fractures

Study Results

No Results Posted as of Feb 11, 2022