Feasibility and Usability of Intrinsic Capacity Monitoring With Eforto and Its Predictive Value for Health Outcomes in Older Community-dwelling Persons
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- Feasibility of the eforto® system
研究概览
简要总结
In this study, 160 community-dwelling older adults (65 years and older) will be provided with an eforto® system to self-monitor their muscle fatigability and self-perceived fatigue for 2 consecutive days per week during 12 months (if needed with assistance by an informal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.
The aims of the study are:
- to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the eforto® system in the home setting.
- to investigate if changes and variability in intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue), are related to changes in frailty status, functional independency and quality of life.
- to explore whether intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue) is related to circulating inflammatory biomarkers.
详细描述
Investigational device:
The eforto® system was developed based on approximatively 20 years of scientific research on handgrip muscle fatigability performed by the Frailty in Ageing research department (see https://fria.research.vub.be/) and in collaboration with top-level international partners.
The eforto® system allows self-assessment of muscle fatigability and self-perceived fatigue in older adults and functions as a monitoring tool for intrinsic capacity. It is a small device, easy to use, and suitable for home measurements as well as hospital settings. When used correctly, the measurements cause no discomfort and can be performed repeatedly. The rubber bulb connects to a smartphone application that provides verbal test instructions to the participant. The app will guide the participant during the test and automatically provide motivational cues via audio. The test results are aggregated and stored in a cloud platform where the researcher can manage subjects, access the test data and export it for further analysis. The mobile app supports Dutch, French and English.
In a previous study, eforto® was clinically validated against a gold-standard pressure gauge in n=61 community-dwelling older adults, n=26 hospitalized geriatric patients and n=25 older hip fracture patients. Moreover, the usability and acceptance of eforto® self-monitoring (1 week) was demonstrated in a sample of n=30 community dwelling older persons aged between 83 and 95 years old. (paper submitted for publication in international peer-reviewed journal)
Procedures:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Aged 65 years and over
- •Living in the community (independently at home or at home assisted by an informal caregiver or in assistive housing)
- •Being able to operate the basic functions of a smartphone (if needed with assistance by an informal caregiver): using a smartphone at least for calls and minimum 1 other application
- •Understanding Dutch or French
- •Simple Frail Scale score <3
排除标准
- •Being unable to participate in the assessments due to:
- •Physical impairments (e.g. unable to stand up or walk)
- •Cognitive impairments (unable to understand the test instructions and/or Mini Mental State Examination (MMSE) score <23/30)
- •Functional disability of the dominant upper extremity (pare-sis/paralysis, tremor or recent surgery)
结局指标
主要结局
Feasibility of the eforto® system
时间窗: End of the study (week 52)
An self-reported questionnaire (12 questions) based on the technology acceptance model (the Unified Theory of Acceptance Use of Technology (UTAUT)). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.
Usability of the eforto® system
时间窗: Week 52
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.
次要结局
- The correlation between muscle fatigability and functional independency.(12 months)
- The correlation between self-perceived fatigue and functional independency.(12 months)
- The correlation between muscle fatigability and quality of life.(12 months)
- The correlation between self-perceived fatigue and quality of life.(12 months)
- The correlation between self-perceived fatigue and frailty status.(12 months)
- The correlation between self-perceived fatigue and circulating inflammatory biomarkers.(12 months)
- The correlation between muscle fatigability and frailty status.(12 months)
- The correlation between muscle fatigability and circulating inflammatory biomarkers.(12 months)
研究者
Prof. Ivan Bautmans
Professor
Vrije Universiteit Brussel