Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07506941
Acronym
GENEUS 1
Enrollment
209
Registered
2026-04-02
Start date
2026-04-01
Completion date
2027-12-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ageing and Geriatric Health

Keywords

neurosurgery, geriatric medicine

Brief summary

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.

Interventions

None listed

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The evolution of functional autonomy between baseline and 3 months post-dischargebetween baseline and 3-month after dischargeThe 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.

Secondary

MeasureTime frameDescription
Length of hospital staybaseline until the day of hospital dischargeNumber of days from admission to discharge.
Postoperative complicationsthe day of the hospital dischargeComplications classified according to the Clavien-Dindo scale
Daily livingbaseline, the day of hospital discharge and 3-month after dischargescoring of the scale : instrumental activities of daily living (IADL) score 0 is the worst, score 8 is the best autonomy
Composite criteria of Cognitive status and delirium composed of 3 criteriaesbaseline and the day of hospital dischargefirst 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
Psychological statusbaseline and 3month after dischargeScoring of the Patient Health Questionnaire (GDS4) - score is 0 to 4 - 0 is not depressed - 4 is very depressed
Frailtrybaseline, day of hospital discharge and 3 month after dischargescoring of CFS (clinical Frailty scale) - score from 1 to 9 (scores of 1-3 are considered non-frail, 4 to be pre-frail, 5-8 as frail and 9 as terminally ill)
Quality of life scorebaseline, day of hospital discharge, and 3 months after dischargeScoring of the EQ-5D-5L questionnaire (score from 0 to 100 - 0 is better and 100 is the worst)
Composite criteria composed of two criteriaes : functional recovery and autonomy evolution3 months after dischargeScoring of Activities of Daily Living (ADL) : score 0 to 6 : score of 0 is the worst and score 6 is the best and instrumental activities of daily living (IADL scale) score 0 is the worst, score 8 is the best autonomy

Countries

France, Portugal, Spain

Contacts

CONTACTEric SCHMIDT
schmidt.e@chu-toulouse.fr05 61 77 56 06
CONTACTVeronique CHAIGNEAU
chaigneau.v@chu-toulouse.fr
STUDY_DIRECTOREric SCHMIDT

University Hospital of Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026