NCT Number: NCT07506941
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
Limoges University Hospital, Limoges, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Time frame: between baseline and 3-month after 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: baseline until the day of hospital discharge
Number of days from admission to discharge.
Time frame: the day of the hospital discharge
Complications classified according to the Clavien-Dindo scale
Time frame: baseline, the day of hospital discharge and 3-month after discharge
scoring of the scale : instrumental activities of daily living (IADL) score 0 is the worst, score 8 is the best autonomy
Time frame: baseline and the day of hospital discharge
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 3month after discharge
Scoring of the Patient Health Questionnaire (GDS4) - score is 0 to 4 - 0 is not depressed - 4 is very depressed
Time frame: baseline, day of hospital discharge and 3 month after discharge
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)
Time frame: baseline, day of hospital discharge, and 3 months after discharge
Scoring of the EQ-5D-5L questionnaire (score from 0 to 100 - 0 is better and 100 is the worst)
Time frame: 3 months after discharge
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
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
A Prospective, Multicenter, and Transnational Study of Functional Decline and Care Pathways in Neurosurgical Patients Over 65 Years of Age
Acronym: GENEUS 1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07419633
Ageing, Ageing and Geriatric Health
Montreal, Quebec, Canada
View Trial DetailsNCT07251855
Ageing and Geriatric Health
Putrajaya, Malaysia
View Trial DetailsNCT07124949
Ageing and Geriatric Health, Cardiovascular Diseases
Harbin, Heilongjiang, China
View Trial Details