Study of Functional Decline and Care Pathways in Neurosurgical Patients Over 65 Years of Age (GENEUS 1)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ageing and Geriatric Health

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.

• Study Type: Observational
• Enrollment (Estimated): 209

Contacts and Locations

• Study Contact: Name: Eric SCHMIDT; Phone Number: +33 05 61 77 56 06; Email: schmidt.e@chu-toulouse.fr
• Study Contact Backup: Name: Veronique CHAIGNEAU; Email: chaigneau.v@chu-toulouse.fr

Study Locations

• France
  • Limoges, France
    • Limoges University Hospital
    • Principal Investigator: Francois CAIRE
• Portugal
  • Lisbon, Portugal
    • CUF Descobertas
    • Principal Investigator: Ricardo Malcata Nogueira
  • Lisbon, Portugal
    • ULS Santa Maria
    • Principal Investigator: Diogo Roque
• Spain
  • Alicante, Spain
    • Hospital General Universitario Alicante
    • Principal Investigator: Pablo González-López
  • Ourense, Spain
    • Complexo Hospitalario De Ourense
    • Principal Investigator: Ana PASTOR
  • Pamplona, Spain
    • Navarrabiomed
    • Principal Investigator: Idoya Zazpe Cenoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years or older admitted for neurosurgical intervention, for whom follow-up for 3 months is possible given their cognitive status and life expectancy, and who agrees to the retrieval of their hospital clinical and health economic data during the year following their discharge from the hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	between baseline and 3-month after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Number of days from admission to discharge.	baseline until the day of hospital discharge
Postoperative complications	Complications classified according to the Clavien-Dindo scale	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	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	baseline and the day of hospital discharge
Psychological status	Scoring of the Patient Health Questionnaire (GDS4) - score is 0 to 4 - 0 is not depressed - 4 is very depressed	baseline and 3month after discharge
Frailtry	scoring 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)	baseline, day of hospital discharge and 3 month after discharge
Quality of life score	Scoring of the EQ-5D-5L questionnaire (score from 0 to 100 - 0 is better and 100 is the worst)	baseline, day of hospital discharge, and 3 months after discharge
Composite criteria composed of two criteriaes : functional recovery and autonomy evolution	Scoring 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	3 months after discharge

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Study Director: Eric SCHMIDT, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: geriatric medicine; neurosurgery
• Other Study ID Numbers: RC31/25/0220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No