NCT06270979尚未招募不适用
Feasibility and Usability of Intrinsic Capacity Monitoring With an Integrated Data Eco-System for Healthy Ageing, and Its Association With Health Outcomes in Older Patients Undergoing Rehabilitation and in Older Nursing Home Residents.
Prof. Ivan Bautmans0 个研究点目标入组 120 人开始时间: 2024年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Potential technical problems of the ISHA system
研究概览
简要总结
In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal 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 ISHA system in rehabilitation and nursing home settings.
- to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.
- to explore individual trajectories of intrinsic capacity with the ISHA system.
详细描述
Investigational device:
The ISHA digital eco-system (class IIa investigational medical device).
ISHA consists of 3 components:
- An Eforto® device: a handheld grip work (GW) hardware device, composed of a rubber bulb, to be compressed by the user and plastic enclosure that holds the electronic components such as a pressure sensor, battery, and connectivity. A mouthpiece can be attached for respiratory capacity monitoring.
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.
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 or older.
- •Patients living independently at home and undergoing rehabilitation, or older persons living in the residential care community (in a nursing home or in assisted 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.
排除标准
- •Being unable to participate in the assessments due to:
- •Being unable to perform the physical (self)tests (e.g., unable to stand up or walk);
- •Being unable to understand the test instructions;
- •Functional disability of the dominant upper extremity (paresis/paralysis, tremor or recent surgery);
- •Patients undergoing neurological rehabilitation.
结局指标
主要结局
Potential technical problems of the ISHA system
时间窗: Week 16
A checklist of potential technical problems (12 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.
Experiences with ISHA (usability, feasibility and acceptability outcome)
时间窗: End of the study (week 16)
An self-reported questionnaire (19 questions) based on the System Usability Scale (SUS). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.
次要结局
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB(4 months)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).(4 months)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB(4 months)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)(Baseline)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB(4 months)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)(4 months)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)(4 months)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)(4 months)
- The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)(4 months)
- The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol).(4 months)
研究者
Prof. Ivan Bautmans
Professor
Vrije Universiteit Brussel
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