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Not yet recruiting NCT07506941

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

Observational Ageing and Geriatric Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ageing and Geriatric Health. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Portugal, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Detailed description

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.

Primary outcome measures

  • The evolution of functional autonomy between baseline and 3 months post-discharge [Time frame: between baseline and 3-month after discharge]
Secondary outcome measures (8)
  • Length of hospital stay [Time frame: baseline until the day of hospital discharge]
  • Postoperative complications [Time frame: the day of the hospital discharge]
  • Daily living [Time frame: baseline, the day of hospital discharge and 3-month after discharge]
  • Composite criteria of Cognitive status and delirium composed of 3 criteriaes [Time frame: baseline and the day of hospital discharge]
  • Psychological status [Time frame: baseline and 3month after discharge]
  • Frailtry [Time frame: baseline, day of hospital discharge and 3 month after discharge]
  • Quality of life score [Time frame: baseline, day of hospital discharge, and 3 months after discharge]
  • Composite criteria composed of two criteriaes : functional recovery and autonomy evolution [Time frame: 3 months after discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 3 centers
  • Hospital General Universitario Alicante — Alicante
  • Complexo Hospitalario De Ourense — Ourense
  • Navarrabiomed — Pamplona
Portugal · 2 centers
  • CUF Descobertas — Lisbon
  • ULS Santa Maria — Lisbon
France · 1 center
  • Limoges University Hospital — Limoges

Identifiers

NCT: NCT07506941 · RC31/25/0220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗