Healthy Aging Together - "Getting to Know You Better": Healthy Aging and Predictive Indicator (BVE-HAPI)

A key challenge lies in preventing the loss of autonomy and promoting healthy aging-a concept now widely addressed through multidimensional and multidisciplinary approaches, as evidenced by frailty models, comprehensive geriatric assessment practices, and the WHO's "intrinsic capacity" model. That said, there is a need to assess in greater detail the extent to which individual factors contribute to health trajectories and to move further by adopting a systemic approach that examines not only the relationships between variables but also their complex interactions. The aim of this study is to identify the multidimensional determinants (medical, physical, nutritional, sensory, psycho-cognitive, psychosocial, and socioeconomic) associated with the autonomy and quality of life of older adults and those who are aging.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

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

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 years or older
  • Affiliation with or beneficiary of a social security scheme
  • No objection to the study

Exclusion Criteria:

  • Persons protected by law, under guardianship or curatorship,
  • Persons 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: Assessed group
Questionnaires and tests on health behaviors and health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of Autonomy
Time Frame: at baseline, 6 months later and 12 months later

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, 6 months later and 12 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: at baseline, 6 months later and 12 months later

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, 6 months later and 12 months later
Daily Physical activity Practice (physical behavioral lifestyle measure
Time Frame: at baseline, 6 months later and 12 months later
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, 6 months later and 12 months later
Sarcopenia (physical measure)
Time Frame: at baseline, 6 months later and 12 months later
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, 6 months later and 12 months later
Physical functional force (physical measure)
Time Frame: at baseline, 6 months later and 12 months later
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, 6 months later and 12 months later
Eating habits (nutritional behavioral lifestyle measure
Time Frame: at baseline, 6 months later and 12 months later
Eating habits is assessed using items from the Senior in the Community: Risk Evaluation for Eating and Nutrition (SCREEN) questionnaire. Higher score indicated better eating habits.
at baseline, 6 months later and 12 months later
Body Mass Index (nutritional measure)
Time Frame: at baseline, 6 months later and 12 months later
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 later
Subjective cognitive complaint (cognitive measure)
Time Frame: at baseline, 6 months later and 12 months later
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, 6 months later and 12 months later
Working memory (cognitive measure)
Time Frame: : at baseline, 6 months later and 12 months later
Working memory is assessed using a visual test consisting of remembering the order in which targets are illuminated. More recalls correspond to a better score.
: at baseline, 6 months later and 12 months later
Psychological quality (psychological measure)
Time Frame: at baseline, 6 months later and 12 months later
Psychological quality is assessed using items from the World Health Organization Quality of Life-Spirituality, Religiousness and Personal Beliefs (WHOQOL-SRPB) questionnaire. Each item is scored from 1 to 5. Higher score is better.
at baseline, 6 months later and 12 months later
Locus of Control (psycho-social measure)
Time Frame: at baseline, 6 months later and 12 months later
: Locus of Control is assessed using items from the Multidimensional Health Locus of Control Scale. It is a 5-point Likert scale. The questionnaire helps to see if the person thinks that their health depends mainly on their own behavior, that it is perceived as being linked to chance, or that it depends mainly on professionals.
at baseline, 6 months later and 12 months later

Collaborators and Investigators

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

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)

November 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 24, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 25-PP-30

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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