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

NCT ID: NCT05091645

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-25

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Frailty Syndrome Hip Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hip fracture_GFI

Greek patients with hip fracture assessed for frailty syndrome with the adapted for the greek population GFI questionnaire

GFI

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Elena Arnaoutoglou

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleni Arnaoutoglou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Michael Hantes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Locations

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University of Thessaly

Larissa, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Eleni Arnaoutoglou, MD, PhD

Role: CONTACT

[email protected]
+306974301352

Maria Ntalouka, MD, PhD, MSc

Role: CONTACT

[email protected]
+306973688099

Facility Contacts

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Eleni Arnaoutoglou, MD, PhD

Role: primary

[email protected]
+306974301352

Maria Ntalouka, MD, PhD

Role: backup

[email protected]
+306973688099

Other Identifiers

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Gr-Groningen Frailty Indicator

Identifier Type: -

Identifier Source: org_study_id