Study of Functional Decline and Care Pathways in Neurosurgical Patients Over 65 Years of Age

Официальное название

A Prospective, Multicenter, and Transnational Study of Functional Decline and Care Pathways in Neurosurgical Patients Over 65 Years of Age

Обзор

The GENEUS 1 study addresses this gap by characterizing the real-world profiles, outcomes, and care pathways of adults aged 65 years and older hospitalized in neurosurgery across France, Spain, and Portugal. This project represents the first multicentre, transnational initiative to integrate geriatric principles into neurosurgical practice and to evaluate both clinical and economic outcomes in this population.

Подробное описание

This is a prospective, multicentre, multinational, observational study.

Seven neurosurgical centres in France, Spain, and Portugal will participate. Each participant will be followed at three timepoints:

V0 (Admission): baseline clinical and geriatric assessment. V1 (Discharge): length of stay, complications, and updated functional and cognitive status.

V2 (3 months ±1 week): structured telephone follow-up or face-to-face visit to assess readmission, autonomy, and quality of life.

A 12-month medico-economic component (only in France) will evaluate healthcare utilization and costs using clinical data, patient or caregiver questionnaires, and linkage with the Système National des Données de Santé (SNDS) in France.

Первичные конечные точки

• The evolution of functional autonomy between baseline and 3 months post-discharge [Срок оценки: between baseline and 3-month after discharge]

Вторичные конечные точки (8)

• Length of hospital stay [Срок оценки: baseline until the day of hospital discharge]
• Postoperative complications [Срок оценки: the day of the hospital discharge]
• Daily living [Срок оценки: baseline, the day of hospital discharge and 3-month after discharge]
• Composite criteria of Cognitive status and delirium composed of 3 criteriaes [Срок оценки: baseline and the day of hospital discharge]
• Psychological status [Срок оценки: baseline and 3month after discharge]
• Frailtry [Срок оценки: baseline, day of hospital discharge and 3 month after discharge]
• Quality of life score [Срок оценки: baseline, day of hospital discharge, and 3 months after discharge]
• Composite criteria composed of two criteriaes : functional recovery and autonomy evolution [Срок оценки: 3 months after discharge]

Критерии участия

Критерии включения

Age ≥ 65 years at the time of admission Admission to a neurosurgery department in one of the participating centres (France, Spain, or Portugal), Affiliation with a national health-insurance or equivalent system Feasibility of follow-up at 3 months, Consent/non-opposition for the study

Критерии исключения

Terminal illness (neurosurgical or not) with an estimated life expectancy of < 3 months.

Loss of autonomy prior to admission, established as ADL < 3. For a patient admitted to the emergency hospital, ask him (or his caregiver) about his functional abilities before his condition deteriorated.

Legal protection status (guardianship, trusteeship, or judicial protection) when such status prevents lawful consent or non-opposition.

Participation in another interventional clinical study whose procedures or follow-up could interfere with GENEUS 1 objectives or endpoints.

Severe cognitive or communication impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 3 центра

• Hospital General Universitario Alicante — Alicante
• Complexo Hospitalario De Ourense — Ourense
• Navarrabiomed — Pamplona

Португалия · 2 центра

• CUF Descobertas — Lisbon
• ULS Santa Maria — Lisbon

Франция · 1 центр

• Limoges University Hospital — Limoges

Идентификаторы

NCT: NCT07506941 · RC31/25/0220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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