Clinical trial NCT04224038: The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform
Official title: The Inspire Bio-resource Research Platform for Healthy Aging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biological Aging
Keywords: Geroscience
biological aging and identifying targetable biomarkers
The Inspire Bio-resource Research Platform for Healthy Aging
Aged 30 years-old or over
age-related chronic diseases
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
First posted: 2020-01-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment will be stratified per 10-year age groups, oversampling older people in order to be able to investigate major clinical events (eg, declines on IC, onset of age-related diseases)

Brief summary: Since aging is a systemic (not organ-specific) phenomenon, the main objective of Inspire Bio-resource Research Platform for Healthy Aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and IC evolution. The Inspire Platform will gather data and biospecimens from subjects of different ages (from 30 years or over - no upper limit for age) and functional capacity levels (from robust to frail to disabled) over 10 years.

Detailed description: This is a 10-year observational study. The study will be performed in Occitania Region. Once a year, a complete data collection will be performed in the Gerontopole of Toulouse, in participants' home and health centers by the Gerontopole mobile research team, and in selected Gerontopole's collaborating centers in Occitania.

Between yearly waves of data collection, participants will have their intrinsic capacity domains monitored (with or without the help of a caregiver) each 4-month through the use of either an app developed in collaboration with World Health Organization (WHO) or a web platform; or through a phone call by a clinical/research nurse. For the first self-monitoring of IC at four months, all participants will be contacted by a research/clinical nurse by phone; this call will inform about how participants measured their capacity and/or help them to do it. After this first 4-month phone call, participants capable of correctly self-monitoring their IC through the app will no longer be systematically contacted by phone. Once IC declines are confirmed, participants will have a thorough clinical assessment and blood sampling; such information will allow us to investigate the response of markers of aging at the time declines are detected. Those needing usual care, will be followed according to WHO framework recommendations proposed for Integrated Care for Older Adults (ICOPE).

Eligibility criteria: Inclusion Criteria:

* Aged 30 years-old or over;
* Both sexes
* Affiliated to a social security scheme

Exclusion Criteria:

* severe disease compromising life expectancy at 5 years;
* Deprived of their liberty by administrative or judicial decision, or under guardianship

Primary outcomes:
measure: Data collection of key variables and biospecimens
timeFrame: through study completion, an average of 10 years
Secondary outcomes:
measure: Identification of (a set of) biomarkers of aging through the constitution of a comprehensive biobank comprising: blood, saliva, urine, nasopharyngeal swabbing, skin biopsies and surface samples, dental plaque, faeces, hair bulb.
timeFrame: through study completion, an average of 10 years
measure: measure intrinsic capacity domains with questionnaire in ICOPE App (developed in collaboration with W.H.O.)
timeFrame: through study completion, an average of 10 years
measure: Basic and instrumental activities of daily living.
timeFrame: through study completion, an average of 10 years
measure: Mini-nutritional assessment and food frequency questionnaire.
timeFrame: through study completion, an average of 10 years
measure: Lifestyle questionnaires
timeFrame: through study completion, an average of 10 years
measure: ActivPAL: objectively physical activity parameters.
timeFrame: through study completion, an average of 10 years
measure: Self-reported visceral pain.
timeFrame: through study completion, an average of 10 years
measure: Participant-reported outcome for cognition (CFI)
timeFrame: through study completion, an average of 10 years
measure: Participant-reported outcome for mobility
timeFrame: through study completion, an average of 10 years
measure: Participant-reported outcome for fatigue
timeFrame: through study completion, an average of 10 years
measure: Participant-reported outcome for social isolation (PROMIS)
timeFrame: through study completion, an average of 10 years
measure: Participant-reported outcome for SARQoL.
timeFrame: through study completion, an average of 10 years
measure: Participant-reported outcome for cognition (CFI) and mobility, fatigue, and social isolation (PROMIS), and SARQoL.
timeFrame: through study completion, an average of 10 years
measure: Oral Health Assessment Tool (OHAT).
timeFrame: through study completion, an average of 10 years
measure: Short physical performance battery and 30-sec chair rise test.
timeFrame: through study completion, an average of 10 years
measure: The mini-mental state examination (MMSE)
timeFrame: through study completion, an average of 10 years
measure: neuropsychological tests.
timeFrame: through study completion, an average of 10 years
measure: Skin elasticity (cutometer measurement)
timeFrame: through study completion, an average of 10 years
measure: Dual Energy X-ray absorptiometry
timeFrame: through study completion, an average of 10 years
measure: maximum oxygen consumption
timeFrame: through study completion, an average of 10 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Bruno VELLAS, MD
role: PRINCIPAL_INVESTIGATOR
References: