- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07651527
Aging Well Together - 'Getting to Know You Better': Characterization of Health FACTors in People Advancing in AGE (BVE-FACTAGE)
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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Olivier GUERIN, Pr
- Telefonnummer: +33 0492034194
- E-Mail: guerin.o@chu-nice.fr
Studieren Sie die Kontaktsicherung
- Name: Lyne DAUMAS
- E-Mail: Lyne.DAUMAS@univ-cotedazur.fr
Studienorte
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Nice, Frankreich
- CHU de Nice - Hopital de Cimiez
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Hauptermittler:
- Olivier GUERIN, Professor
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Kontakt:
- Olivier GUERIN, Pr
- Telefonnummer: +33 0492034194
- E-Mail: guerin.o@chu-nice.fr
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Kontakt:
- Lyne DAUMAS
- E-Mail: Lyne.DAUMAS@univ-cotedazur.fr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: FACTAGE
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Questionnaires and tests on health behaviors and health
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Autonomy
Zeitfenster: at baseline and at 6 months and at 12 months
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Care consumption, health behavior and psycho-socio-environmental characteristics
Zeitfenster: at baseline and at 6 and 12 months
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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).
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at baseline and at 6 and 12 months
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Measure Quality of life
Zeitfenster: at baseline and at 6 months and at 12 months
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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
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Physical functional force (physical measure)
Zeitfenster: at baseline and at 6 months and at 12 months
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: 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.
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at baseline and at 6 months and at 12 months
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Sarcopenia (physical measure)
Zeitfenster: at baseline and at 6 months and at 12 months
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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.
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at baseline and at 6 months and at 12 months
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Daily Physical activity Practice (physical behavioral lifestyle measure
Zeitfenster: at baseline and at 6 months and at 12 months
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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".
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at baseline and at 6 months and at 12 months
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Subjective cognitive complaint (cognitive measure)
Zeitfenster: at baseline and at 6 and 12 months
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Subjective cognitive complaint is assessed using items from the ICOPE cohort, regarding the presence and worsening (yes/no) of memory and orientation problems
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at baseline and at 6 and 12 months
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Body Mass Index (nutritional measure)
Zeitfenster: at baseline, 6 months later and 12 months
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Body Mass Index corresponds to corresponds to weight (kg) divided by height (m) squared.
The unit is kg/m2.
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at baseline, 6 months later and 12 months
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Memory (cognitive measure)
Zeitfenster: at baseline, 6 months later and 12 months
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Memory is assessed using a 3-word recall test.
Recalling a word is worth 1 point.
A higher score is better.
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at baseline, 6 months later and 12 months
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Cognitive attention (cognitive measure)
Zeitfenster: at baseline, 6 months later and 12 months
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Cognitive attention is assessed consisting of asking to change the focus of attention.
Fewer errors result in a better score
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at baseline, 6 months later and 12 months
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Verhalten
- Motorik
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Therapeutika
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Verhaltenskontrolle
- Immobilisierung
- Umfragen und Fragebögen
- Zurückhaltung, physisch
Andere Studien-ID-Nummern
- 25-PP-15
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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