- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07734246
Healthy Aging Together - "Getting to Know You Better": Healthy Aging and Predictive Indicator (BVE-HAPI)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lyne DAUMAS
- Email: Lyne.DAUMAS@univ-cotedazur.fr
Study Contact Backup
- Name: Olivier GUERIN, PROFESSOR
- Phone Number: +33492034194
- Email: guerin.o@chu-nice.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 25-PP-30
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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