Implementation of the Integrated Care of Older People App and ICOPE Monitor in Primary Care (ICOPE)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence of frailty
研究概览
简要总结
Introduction: The World Health Organization has launched the INSPIRE-ICOPE-CARE program towards healthy aging. It includes "intrinsic capacity", defined as "the composite of all the physical and mental capacities of an individual", which has a positive value towards prevention, and is constructed by five domains: cognition, vitality/nutrition, sensory, psychology, and mobility. ICOPE App and ICOPE Monitor are applications for the self-assessment and monitoring of intrinsic capacity.
Hypothesis: Intrinsic capacity self-assessed by the ICOPE Apps could be associated with the incidence of frailty and health outcomes. ICOPE Apps might support geriatric and primary care during the COVID-19 pandemic and beyond.
Objectives: To assess the association between intrinsic capacity measured by the ICOPE Apps at baseline and the incidence of frailty in community-dwelling older adults during 1-year follow-up. Secondarily, to assess the association of intrinsic capacity and pre-frailty, falls, functional decline, institutionalization, and mortality (COVID-19-related/not related).
Methods: Protocol for a cohort study of community-dwelling adults ≥65-year-old, with no other exclusion criteria than the inability to use the Apps or communicate by telephone/video-call for any reason (cognitive or limited access to telephone/video-call). Intrinsic capacity measured by the ICOPE Apps and Rockwood's clinical frailty scale will be assessed at baseline, 4-, 8- and 12-month follow-up by telephone/video-call. Assuming a prevalence of frailty of 10.7%, and incidence of 13% (alpha-risk=0.05), 400 participants at 12-month end-point (relative precision=0.10) and 600 participants at baseline will be required.
Associations among the decrease in intrinsic capacity, incidence of frailty, and occurrence of health adverse outcomes during 1-year follow-up are expected. ICOPE Apps might identify individuals at higher risk of frailty and health adverse consequences. The implementation of the ICOPE Apps into clinical practice might help to bring the practitioners closer to their patients, deliver efficient person-centered care-plans, and benefit the healthcare systems during the COVID-19 pandemic and beyond.
详细描述
INTRODUCTION The World Health Organization aims at promoting initiatives focused on the preservation of individuals' physical and mental capacities to achieve older ages in a good health status (Healthy Aging). The INSPIRE Integrated Care for Older People (ICOPE)-CARE is an European program for healthy aging and geroscience research developed by the WHO and coordinated by Gérontopôle of Toulouse (France) in the Occitania Region since 2019. The INSPIRE ICOPE-CARE program will provide evidence about trajectories of life (Normograms for Healthy Ageing Standards), going from animal models to humans and the healthcare systems. As a second step, the French government is aligned with the strategy of WHO 2020-2030 for the continuity of this line of research (https://www.who.int/ageing/en/) and the French Presidential Plan Grand Age has scheduled the implementation of the program INSPIRE ICOPE-CARE in France. This is aligned with other European national healthcare plans, where the implementation of new technologies is considered as an efficient resource to improve patients' health.
INSPIRE ICOPE-CARE includes the assessment of "intrinsic capacity", a new term launched in the WHO in the plan of action 2016-2020. The operational definition of "intrinsic capacity" is "the composite of all the physical and mental capacities of an individual" and is constructed by 5 domains: locomotion, vitality, sensory (vision and hearing), cognition, and psychological domain. Intrinsic capacity has a positive values focusing on disease prevention, and influencing the viewpoint from a negative paradigm of ageing (diseases, disability, frailty, etc.) towards the positive focus of a "healthy aging".
The INSPIRE ICOPE-CARE program involves the self-assessment of intrinsic capacity by new technologies. Indeed, the ICOPE application (App) is self-administered for the screening of intrinsic capacity, and, the ICOPE Monitor is aimed on the diagnosis and 4-month monitoring of intrinsic capacity. The two Apps, already in use as part of the INSPIRE ICOPE-CARE program, are available free-of-charge in Apple or Android Store. Frailty, defined as a "syndrome characterized by a clinical state in which there is an increase in an individual's vulnerability for developing an increased dependency and/or mortality when exposed to a stressor", is also a construct of several domains. However, there are wide differences among frailty and intrinsic capacity, i.e. frailty is driven by deficits, while intrinsic capacity is driven by reserves; frailty is an approach towards treatment usually measured in clinical settings, while intrinsic capacity is a preventive approach focused on the community setting; frailty has wide evidence about its prognosis capacity, while intrinsic capacity is quite new; and finally, frailty assessment requires the administration of comprehensive geriatric assessment by a healthcare professional, while intrinsic capacity could be self-assessed. It would be expected that intrinsic capacity, measured by the Apps is associated to frailty, but this association remains unexplored.
The onset of the COVID-19 pandemic due to a novel coronavirus (SARS-CoV-2) in December 2019 has drastically change the world and clinical practice. Older patients are one of the populations most affected by COVID-19, with a mortality rate of 8% in patients 70-79-year-old, 14.8% in those aged ≥80 years, and higher mortality in frail older individuals, as frailty increases probability of all-cause mortality and death by infectious diseases. The limited availability of primary care resources and the cancellation/delay of visits in outpatients' clinics is hindering the control of chronic diseases, and increases the risk of acute decompensation of chronic diseases in the short and medium term. These patients would lose their health status and become frail, entering in the so called new "COVID Spiraling Frailty Syndrome". Despite healthy general population is finishing quarantine since May 2020, it is still unclear the duration of the isolation measures in safety conditions in older population, particularly in presence of frailty. It seems timely to unleash the potential of academic discoveries to help older people to maintain a good health status and survive.
The investigators hypothesize that intrinsic capacity, self-assessed by the ICOPE App and Monitor at baseline, could identify individuals at higher risk of developing frailty and health adverse outcomes during 1-year follow-up. If these hypotheses are confirmed, ICOPE Apps could be incorporated into clinical practice during the pandemic of COVID-19 and beyond.
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
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of frailty
时间窗: 1 year
Incidence of frailty assessed by Rockwood's clinical frailty scale (CFS) will be assessed at baseline and 12-month follow-up by telephone/video-call. An score \<4 will indicate robustness, 4-6 pre-frailty status, and ≥6 frailty
次要结局
未报告次要终点
研究者
Dolores Sanchez-Rodriguez
MD PhD
University of Liege
