Aging Well Together - 'Getting to Know You Better': Characterization of Health FACTors in People Advancing in AGE (BVE-FACTAGE)

June 11, 2026 updated by: Centre Hospitalier Universitaire de Nice

BVE-FACTAGE: Aging Well Together - 'Getting to Know You Better': Characterization of Health FACTors in People Advancing in AGE

In order to implement effective actions to prevent the loss of autonomy in older adults, which has become a major issue, a crucial first step is to identify the conditions that influence it. Current approaches to health increasingly rely on a comprehensive and multidisciplinary vision, in line with so-called "socio-ecological" approaches, which argue that health is influenced by a wide range of interacting factors. However, these interdependencies and interactions are still poorly understood. It therefore seems necessary to move beyond the isolated analyses of risk factors carried out to date and adopt a holistic/systemic vision by examining both individual and environmental factors, as well as their interactions, which together can contribute to functional decline or the development of pathologies in older adults and those aging.

The aim of this study is to identify the relationships between intrapersonal and environmental factors, and their cumulative, moderating, and mediating effects on the health of older adults and those experiencing aging.

To this end, participants will be asked to complete a series of questionnaires and perform tests on various health-related dimensions. The evaluation criteria are: health, autonomy and quality of life, individual factors (health practices (e.g., physical activity), psychological characteristics (e.g., personal beliefs), socioeconomic status, etc.) and environmental factors (accessibility, living environment).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 55 or older
  • Affiliation with, or beneficiary of, a social security system
  • No objection to the study

Exclusion Criteria:

  • Individuals protected by law
  • unable to participate in a clinical trial
  • deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FACTAGE
Other: Questionnaire and Physical Exam
Questionnaires and tests on health behaviors and health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomy
Time Frame: at baseline and at 6 months and at 12 months

Autonomy is assessed using the Instrumental Activities of Daily Living (IADL) Scale of Lawton.

The scale comprises 8 items. The total score ranges from 0 to 8, with a higher score being better.
at baseline and at 6 months and at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Care consumption, health behavior and psycho-socio-environmental characteristics
Time Frame: at baseline and at 6 and 12 months
The evaluation criteria will be, on the one hand, the same individual and environmental factors (e.g., personal beliefs, socio-economic status, accessibility, physical activity, diet) mentioned previously for the main objective, and on the other hand, the consumption of care (number and types of care).
at baseline and at 6 and 12 months
Measure Quality of life
Time Frame: at baseline and at 6 months and at 12 months

Quality of life is assessed using the EuroQol at 5 dimensions (EQ-5D) questionnaire.

The scale comprises 5 items. Each item is scored from 1 "no problem" to 3 "severe problem". The total score ranges from 5 to 15 with higher score indicating a worse outcome.
at baseline and at 6 months and at 12 months
Physical functional force (physical measure)
Time Frame: at baseline and at 6 months and at 12 months
: Physical functional force is assessed using the 5 sit-to-stand test wich consists of asking the participant to stand up and sit down from a chair 5 times as quickly as possible. The outcome is the time taken to complete the test, and the unit of measurement is seconds.
at baseline and at 6 months and at 12 months
Sarcopenia (physical measure)
Time Frame: at baseline and at 6 months and at 12 months
Sarcopenia is assessed using the SARC-F questionnaire comprising 5 items assessing force, walk difficulties, stand up capacities, climb stairs capacities and fall. Each item is scored from 0 to 2. The total score ranges from 0 to 10 with higher score indicating a worse outcome.
at baseline and at 6 months and at 12 months
Daily Physical activity Practice (physical behavioral lifestyle measure
Time Frame: at baseline and at 6 months and at 12 months
Daily Physical activity Practice is assessed using the Marshall questionnaire comprising 2 items. The total score ranges from 0 to 8. A higher score means a higher level of physical activity. The cut of 4 correspond to "sufficiently active".
at baseline and at 6 months and at 12 months
Subjective cognitive complaint (cognitive measure)
Time Frame: at baseline and at 6 and 12 months
Subjective cognitive complaint is assessed using items from the ICOPE cohort, regarding the presence and worsening (yes/no) of memory and orientation problems
at baseline and at 6 and 12 months
Body Mass Index (nutritional measure)
Time Frame: at baseline, 6 months later and 12 months
Body Mass Index corresponds to corresponds to weight (kg) divided by height (m) squared. The unit is kg/m2.
at baseline, 6 months later and 12 months
Memory (cognitive measure)
Time Frame: at baseline, 6 months later and 12 months
Memory is assessed using a 3-word recall test. Recalling a word is worth 1 point. A higher score is better.
at baseline, 6 months later and 12 months
Cognitive attention (cognitive measure)
Time Frame: at baseline, 6 months later and 12 months
Cognitive attention is assessed consisting of asking to change the focus of attention. Fewer errors result in a better score
at baseline, 6 months later and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-PP-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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