Wearable Device Remote Monitoring to Prevent Frailty Progression in Elderly: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Study protocol assessment
研究概览
简要总结
Frailty is a frequent condition in elderly, characterized by reduced physiologic reserve, leading to an increased risk for adverse events, such as disability, hospitalization, and death. In particular, it is a multidimensional disfunctional condition, including decreases in physiologic capacity in neurologic control (indicated by diminished ability to perform complex tasks), mechanical performance (e.g. diminished strength), and energy metabolism (e.g. decreased aerobic status due to cardiac or pulmonary diseases or both). All these factors lead to the worsening of quality of life. Focusing on the great impact of this condition in global population and the rising of social/health costs, related to this condition, frailty is earning a great interest from both at political level and European Community. For this reason, developing interventions programs aiming to prevent the progression of frailty towards the independence loss, it is considered a key objective for the improvement of the quality of life. In this context, this pilot study looks at the standardization of a study protocol to develop a useful model for enhancing local care in small population isolates, by remotely monitoring the health status of pre-frail subjects and improving the progression of the frailty condition, in order to support a healthy ageing for future investigation including a larger number of individuals.
详细描述
Frailty is a condition of increased vulnerability to stressors due to age-related declines in physiologic reserves across neuromuscular, metabolic, and immune systems. It is considered a medical geriatric syndrome with multiple causes and contributors and it is characterized by diminished strength, power and endurance. In general, therefore, frailty is considered to be a multifactorial dysfunctional framework which includes the physical, psychological, cognitive, economic and social spheres and which leads to a serious deterioration in the quality of life. Due to the great impact of this condition on quality of life, developing interventions programs aiming to prevent the progression of frailty towards the independence loss, it is considered a key objective to support an healthy ageing.
In this context, the primary aim of the present pilot study is to standardize a study protocol to develop a useful model to enhance local care in small population isolates, by remotely monitoring the health status of pre-frail subjects and to improve the progression of the frailty condition, in order to support a healthy ageing for future investigation including a larger number of individuals.
Additional aims:
- To quantify the timeframes necessary for the subjects recruiting and examination activities,including questionnaires and functional tests administration;
- To quantify the training time needed to explain the use of the wearable device to the recruited elderly individuals;
- To assess the responsiveness of pre-frail subjects, during the preliminary screening, the examination visit and the monitoring period (follow-up 6 months);
- To evaluate the compliance of pre-frail individuals with the use of the wearable device.
All men and women aged >= 65 years, resident a small mountain village (Salcito) in Molise region, Italy, will be invited to participate at the first examination, in order to evaluate their frailty condition, in a specific way their pre-frail/frail condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Diagnosis of Pre-Frail;
- •Salcito (a small mountain village in Molise region) residents.
排除标准
- •Age< 65 years;
- •Individuals affected by physical or mental diseases, pacemaker or other medical device keeper who make the use of "wearable device" not possible or unable to complete functional tests.
结局指标
主要结局
Study protocol assessment
时间窗: From February 2022 to August 2023
To standardize a study protocol to develop a useful model for enhancing local care in small population isolates, by remotely monitoring the health status of pre-frail subjects and improving the progression of the frailty condition in order to support a healthy ageing for future investigation including a larger number of individuals.
次要结局
- Recruitment phase(From February 2022 to May 2022)
- Training Phase(From February 2022 to May 2022)
- Pre-frail subjects responsiveness(From February 2022 to August 2022)
- Wearable device compliance(From February 2022 to August 2022)
研究者
Licia Iacoviello
Head of the Department of Epidemiology and Prevention
Neuromed IRCCS