The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform (INSPIRE)

• ClinicalTrials.gov Identifier: NCT04224038
• Recruitment Status: Recruiting
• First Posted: January 13, 2020
• Last Update Posted: October 14, 2022
• Sponsor: University Hospital, Toulouse
• Collaborator: European Regional Development Fund
• Information provided by (Responsible Party): University Hospital, Toulouse

Tracking Information

• First Submitted Date: October 15, 2019
• First Posted Date: January 13, 2020
• Last Update Posted Date: October 14, 2022
• Actual Study Start Date: October 16, 2019
• Estimated Primary Completion Date: October 16, 2031 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 7, 2020)

Data collection of key variables and biospecimens [ Time Frame: through study completion, an average of 10 years ]

The main outcome 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 intrinsic capacities (cognition, mobility, nutrition, hearing and visual capacities, psychological capacity) 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 7, 2020)

• 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. [ Time Frame: through study completion, an average of 10 years ]
  1. Markers of aging: The identification of (a set of) markers of aging will be allowed from the constitution of a large dataset of clinical, para-clinical and digital data as well as a comprehensive biobank comprising: blood, saliva, urine, nasopharyngeal swabbing, skin material (swabbing, stripping, biopsies), dental plaque, feces, hair bulb. In this part of the study, we will take advantage of three complimentary approaches to look for the best markers of aging: without a priori approach (omics: transcriptomics, proteomics, lipidomics); semi a priori approach (field-specific omic. I.e. metabolism, inflammation, cell cycle, mitochondrial network…); and targeted approach (pre-identified targets).
• measure intrinsic capacity domains with questionnaire in ICOPE App (developed in collaboration with W.H.O.) [ Time Frame: through study completion, an average of 10 years ]
  Icope app (developed in collaboration with W.H.O.) for smartphone and tablet to measure intrinsic capacity domains. This app will be used for the remote (at-distance) evaluation and monitoring (self-monitoring, monitoring by a caregiver, or a healthcare provider) of intrinsic capacity domains; for the monitoring, we will use only the Icope Step 1. When declines are detected in the Icope Step 1, we will use the Icope Step 2 (data collected by research nurses in a home visit or at the research facility) to confirm the decline and, then, look for the causes determining such declines.
• Basic and instrumental activities of daily living. [ Time Frame: through study completion, an average of 10 years ]
  Basic and instrumental activities of daily living (ADL). Basic ADLs will be assessed using the 6-item (eg, bathing, feeding, dressing) Katz scale; instrumental ADLs (IADL) will be assessed using the 8-item (eg, cooking, manipulating money) Lawton scale. These variables are measured as a clinical measurement of functional ability and, thus, healthy aging in late ages, according to WHO definition.
• Mini-nutritional assessment and food frequency questionnaire. [ Time Frame: through study completion, an average of 10 years ]
  Mini-nutritional assessment (MNA) and food frequency questionnaire. Nutritional status will be evaluated using the MNA (see Vitality description in Icope Step 2). A short (12-item; the question on physical activity has been removed since already investigated using other assessment tools in this project) food frequency questionnaire will be used to assess dietary quality. Nutritional status and diet may affect both intrinsic capacity domains and potential biomarkers of aging.
• Lifestyle questionnaires [ Time Frame: through study completion, an average of 10 years ]
  . Lifestyle questionnaires:

  1. Physical activity (PA) and sedentary time: Based on the International Physical Activity Questionnaire (IPAQ) long form.
  2. Smoking: This will be evaluated by two questions: Do you currently smoke: any tobacco product? ; e-cigarettes? Responses will be anchored by the terms: daily; weekly, but not daily; less often than weekly; not at all.
  3. Alcohol consumption: This will be evaluated by a question of the food frequency questionnaire
  4. Solar exposure: Sun Protection and Exposure Habits Questionnaires
• ActivPAL: objectively physical activity parameters. [ Time Frame: through study completion, an average of 10 years ]
  Objectively measured physical activity (PA) and sleep parameters. This will be assessed with an activPal activity monitor. Participants will wear the activPal for one week every two-years and will bring it back personally to the research facilities. Attention will be paid for participants wearing the activity monitor always during the same season to avoid bias related to seasonal changes. PA is one of the most important behaviors for healthy aging, being associated with both intrinsic capacity domains and biomarkers. Sleep changes are often associated with aging and may affect healthy aging.
• Self-reported visceral pain. [ Time Frame: through study completion, an average of 10 years ]
  Visceral pain. This will be assessed with a 4-item self-reported questionnaire. This questionnaire is particularly important for investigations on biomarkers from feces.
• Participant-reported outcome for cognition (CFI) [ Time Frame: through study completion, an average of 10 years ]
  Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"
• Participant-reported outcome for mobility [ Time Frame: through study completion, an average of 10 years ]
  Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"
• Participant-reported outcome for fatigue [ Time Frame: through study completion, an average of 10 years ]
  Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"
• Participant-reported outcome for social isolation (PROMIS) [ Time Frame: through study completion, an average of 10 years ]
  Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"
• Participant-reported outcome for SARQoL. [ Time Frame: through study completion, an average of 10 years ]
  Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"
• Participant-reported outcome for cognition (CFI) and mobility, fatigue, and social isolation (PROMIS), and SARQoL. [ Time Frame: through study completion, an average of 10 years ]
  Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"
• Oral Health Assessment Tool (OHAT). [ Time Frame: through study completion, an average of 10 years ]
  Oral Health Assessment Tool (OHAT) provides a global overview of oral health. It is composed of 8 items: lips, tongue, gum-mucosa, saliva, natural teeth, prostheses, oral hygiene and pain. Each item is scored 0, 1 or 2. A score of 0 indicates the absence of degradation, a score of 2 indicates a significant presence of degradation, a score of 1 indicates that there is a remarkable modification without a significant or widespread degradation. The minimum score is 0 (satisfactory oral status) and the maximum score is 16 (degraded oral status).
• Short physical performance battery and 30-sec chair rise test. [ Time Frame: through study completion, an average of 10 years ]
  Short physical performance battery (SPPB) and 30-sec chair rise test. The SPPB will be evaluated. With the participants' consent, performance in the SPPB tests will be video-recorded using standard cameras placed in three different angles in the room: the images will be analyzed to look for digital markers of aging through the patterns of motor function and subsequent subjects risk-stratification. The number of chair rises within 30secwill also be assessed in a fraction of participants. These measurements provide clinical information about mobility.
• The mini-mental state examination (MMSE) [ Time Frame: through study completion, an average of 10 years ]
  The Mini-mental state examination (MMSE) and neuropsychological tests. The MMSE is a scale that provides total scores ranging from 0 to 30 (higher values represent better cognitive function). Besides the MMSE, in subjects less than 70 years-old the following neuropsychological tests will be used: free and total recall of the Free and Cued Selective Reminding Test, the Digit Symbol Substitution Test, score from the Wechsler Adult Intelligence Scale-Revised, and the Category Naming Test (2-minute category fluency in animals); when combined in a composite Z-score, these variables provide accurate information about participants' cognitive function.
• neuropsychological tests. [ Time Frame: through study completion, an average of 10 years ]
  The Mini-mental state examination (MMSE) and neuropsychological tests. The MMSE is a scale that provides total scores ranging from 0 to 30 (higher values represent better cognitive function). Besides the MMSE, in subjects less than 70 years-old the following neuropsychological tests will be used: free and total recall of the Free and Cued Selective Reminding Test, the Digit Symbol Substitution Test, score from the Wechsler Adult Intelligence Scale-Revised, and the Category Naming Test (2-minute category fluency in animals); when combined in a composite Z-score, these variables provide accurate information about participants' cognitive function.
• Skin elasticity (cutometer measurement) [ Time Frame: through study completion, an average of 10 years ]
  Skin elasticity (cutometer measurement). This measures the bio-mechanical properties of the skin by applying mechanical stress to the skin. The measuring principle is based on suction and elongation. A device will be used to generate a negative pressure which can vary between 20 and 500 mbar. The area of the skin to be measured is drawn into the probe opening by this pressure. The depth of skin penetration inside the probe opening is determined by an optical measurement system. The stress can be exerted at different depths of the skin: the 2mm probe solicits the skin at the superficial dermis; the 6mm probe engages the skin more deeply, at the level of the deep dermis, at the limit of the hypodermis.
• Dual Energy X-ray absorptiometry [ Time Frame: through study completion, an average of 10 years ]
  Whole body magnetic resonance to measure the Isokinetic muscle strength with Dual Energy X-ray absorptiometry (DEXA°
• maximum oxygen consumption [ Time Frame: through study completion, an average of 10 years ]
  maximum oxygen consumption (VO²max) and aerobic power (blood sampling before and after the effort).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform
• Official Title: The Inspire Bio-resource Research Platform for Healthy Aging
• 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).

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 10 Years
• Biospecimen: Not Provided
• 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)
• Condition: Biological Aging

Intervention

Other: The Inspire Bio-resource Research Platform for Healthy Aging

Several follow-up visits will be undertaken during the 10-year time frame of this project. Some of these visits are not regularly scheduled and will be conditioned by the remote monitoring of intrinsic capacity (IC) and the onset of other major clinical conditions. Other visits correspond to the regularly scheduled (yearly or every two years (biannual visits), depending on the outcome measures) waves of data collection.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 7, 2020): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2033
• Estimated Primary Completion Date: October 16, 2031 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Bruno VELLAS, MD; 5 61 77 70 47 ext +33; vellas.b@chu-toulouse.fr

Contact: Sophie GUYONNET, PhD; 5 61 77 70 43 ext +33; guyonnet.s@chu-toulouse.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04224038
• Other Study ID Numbers: RC31/19/0236
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University Hospital, Toulouse
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Toulouse
• Original Study Sponsor: Same as current
• Collaborators: European Regional Development Fund

Investigators

• Principal Investigator: Bruno VELLAS, MD; University Hospital of Toulouse

• PRS Account: University Hospital, Toulouse
• Verification Date: October 2022