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临床试验/NCT04224038
NCT04224038招募中不适用

The Inspire Bio-resource Research Platform for Healthy Aging

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Data collection of key variables and biospecimens

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Data collection of key variables and biospecimens

时间窗: 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.

次要结局

  • Lifestyle questionnaires(through study completion, an average of 10 years)
  • Short physical performance battery and 30-sec chair rise test.(through study completion, an average of 10 years)
  • Skin elasticity (cutometer measurement)(through study completion, an average of 10 years)
  • 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.(through study completion, an average of 10 years)
  • Mini-nutritional assessment and food frequency questionnaire.(through study completion, an average of 10 years)
  • Self-reported visceral pain.(through study completion, an average of 10 years)
  • measure intrinsic capacity domains with questionnaire in ICOPE App (developed in collaboration with W.H.O.)(through study completion, an average of 10 years)
  • Participant-reported outcome for cognition (CFI)(through study completion, an average of 10 years)
  • Participant-reported outcome for SARQoL.(through study completion, an average of 10 years)
  • Oral Health Assessment Tool (OHAT).(through study completion, an average of 10 years)
  • neuropsychological tests.(through study completion, an average of 10 years)
  • Basic and instrumental activities of daily living.(through study completion, an average of 10 years)
  • The mini-mental state examination (MMSE)(through study completion, an average of 10 years)
  • ActivPAL: objectively physical activity parameters.(through study completion, an average of 10 years)
  • Participant-reported outcome for mobility(through study completion, an average of 10 years)
  • Participant-reported outcome for fatigue(through study completion, an average of 10 years)
  • Participant-reported outcome for social isolation (PROMIS)(through study completion, an average of 10 years)
  • Participant-reported outcome for cognition (CFI) and mobility, fatigue, and social isolation (PROMIS), and SARQoL.(through study completion, an average of 10 years)
  • Dual Energy X-ray absorptiometry(through study completion, an average of 10 years)
  • maximum oxygen consumption(through study completion, an average of 10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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