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NCT Number: NCT07651527

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).

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire and Physical Exam

Other

Questionnaires and tests on health behaviors and health

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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".

  6. 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

  7. 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.

  8. 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.

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lyne DAUMAS

CONTACT

[email protected]

Olivier GUERIN, Pr

CONTACT

[email protected]

0492034194 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: BVE-FACTAGE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

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.

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