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

N/ANot Yet RecruitingNCT07506941

University Hospital, Toulouse209 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

209

Conditions

Ageing and Geriatric Health

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: 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 Exclusion Criteria: 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

Locations (6)

Limoges University Hospital

Limoges, France

CUF Descobertas

Lisbon, Portugal

ULS Santa Maria

Lisbon, Portugal

Hospital General Universitario Alicante

Alicante, Spain

Outcomes

Primary Outcomes

The evolution of functional autonomy between baseline and 3 months post-discharge

The change is measured using validated geriatric scale Basic Activities of Daily Living Functional decline will be defined as any clinically significant decrease in ADL score compared with baseline. The change will be expressed both as a continuous variable (score variation) and as a categorical outcome (improved / stable / declined autonomy). This criterion captures the short-term functional trajectory of older adults after a neurosurgical hospitalization and serves as the main indicator of care effectiveness and adaptation to geriatric needs.

Time frame: between baseline and 3-month after discharge

Secondary Outcomes

Length of hospital stay

Number of days from admission to discharge.

Time frame: baseline until the day of hospital discharge

Postoperative complications

Complications classified according to the Clavien-Dindo scale

Time frame: the day of the hospital discharge

Daily living

scoring of the scale : instrumental activities of daily living (IADL) score 0 is the worst, score 8 is the best autonomy

Time frame: baseline, the day of hospital discharge and 3-month after discharge

Composite criteria of Cognitive status and delirium composed of 3 criteriaes

first criteria : score of the scale of Sclan and Reisberg - score is between 1 and 7 - 1 is the better and 7 the worst second criteria : score of the test for delirium \& cognitive impairment (4AT) - the score is beetwen 0 and 4 - 0 is the better and 4 the worst third criteria : Mini Mental State Examination

Time frame: baseline and the day of hospital discharge

Psychological status

Central Contacts

Eric SCHMIDT

CONTACT

05 61 77 56 06 schmidt.e@chu-toulouse.fr

Veronique CHAIGNEAU

CONTACT

chaigneau.v@chu-toulouse.fr

Data from ClinicalTrials.gov

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