Integrated Monitoring for Independent Living in Rural Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Electrocardiogram (ECG)
研究概览
简要总结
Aging is a biological process that is accompanied by a progressive deterioration of physical and mental abilities and leads to an increased risk of disease. In 2023, Spain will reach an all-time high aging rate of 137.7% due to the low birth rate and increasing life expectancy. In Castilla y León, 47.57% of the population lives in municipalities with fewer than 20,000 inhabitants. This percentage has decreased over the last 10 years, reflecting a clear trend towards rural exodus, and this population loss requires the development of specific measures. Spanish Law 45/2007 includes as one of its objectives the promotion of quality social services and the guarantee of access to public services for older adults. However, geographical dispersion limits the effective implementation of these services. Although Castilla y León has a good network of local clinics, medical care in many municipalities is outpatient and limited to a weekly consultation. This low frequency of face-to-face care hinders the early detection of diseases, leads to a greater number of avoidable hospitalizations and contributes to older adults isolation. Faced with this reality, the VIVIR (Integrated Monitoring for Independent Living in Rural Settings) project proposes the implementation of an innovative system for the continuous monitoring of the health status of the elderly through an advanced comprehensive assessment kit. This kit will include instruments such as electrocardiogram, blood pressure measurement, manual grip strength, assessment of physical and emotional functions, spirometry, body composition and nutritional assessment.
详细描述
Advances in disease prevention and treatment as well as social changes have led to an increase in life expectancy of around 10-20 years in various regions of the world since the 1950s. However, population growth and aging have led to a sharp increase in the number of older people with physical disabilities, i.e. with difficulties in performing activities of daily living. Aging is defined as a biological process characterized by an increasing accumulation of cellular and molecular damage that leads to a decrease in physical and mental abilities and thus to an increased risk of disease. Currently, more than half of the population in the European Union is 65 years old or older. Furthermore, projections for 2050 indicate a decrease in the ratio of working-age people to older people, reflecting the increasing aging of the European population. In 2023, Spain will reach the historical peak of aging with 137.7% of the population. These demographic changes are also expected to increase the number of age-related diseases and conditions, including frailty. Frailty can be defined as a syndrome caused by the combined effect of multiple age-related and associated changes. Specifically, phenotypic frailty is a validated clinical presentation that marks a distinct clinical syndrome and pathophysiology. Furthermore, the 'Frailty Index' calculates the percentage of clinically identified conditions or impairments in relation to the number of measured diseases, symptoms, signs, impairments, disabilities and functional limitations, social environment, physical activity, mental health, cognitive status, self-assessed health and, in some cases, laboratory findings. A preventive assessment together with the implementation of a care and follow-up plan can have benefits for the well-being and independence of older adults, including reduced hospital admissions, falls and long-term mortality.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People living in rural areas of less than 20,000 inhabitants belonging to the Diputación de Valladolid.
- •People aged 60 years or older.
排除标准
- •People with cognitive impairment and difficulty in understanding and responding to verbal commands.
- •People who have been admitted to hospital for more than or equal to one week in the last month prior to inclusion in the study.
研究组 & 干预措施
Older adults living in rural areas
A single cohort of older adults (≥60 years old) will be used to evaluate the ability of a specific kit to assess the health status and predict adverse events
干预措施: Devices: Kardia Mobile 6L; Omron M7 BP ; Beurer PO30; Datospir Peak-10; NUTRILAB BIA 101 BIVA® PRO; JAMAR® Smart. (Other)
结局指标
主要结局
Electrocardiogram (ECG)
时间窗: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
A 6-lead ECG will be performed using the Kardia Mobile 6L portable device (AliveCor Inc., California, USA), which is FDA approved and used in clinical practice. This device connects to an application on the phone via Bluetooth to provide instantaneous readings. To perform the measurement correctly, users are asked to sit and rest for 5 minutes. Afterwards, the user should hold the device so that the thumbs touch the upper electrodes, and the device is in direct contact with the skin of the left leg at the knee or ankle. The device gives a diagnosis about heart beat rhythm (e.g., normal sinoauricular rhythm, arritmia, etc.)
Blood pressure
时间窗: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
An Omron M7 automatic blood pressure monitor (Omron Healthcare Co., Ltd., Kyoto, Japan) will be used to measure blood pressure. According to the recommendations of the American Heart Association, the user should sit in a comfortable chair with lumbar support for at least 5 minutes before the measurement. The participant will be asked to place both feet flat on the floor without crossing the legs and place the arm with the cuff at chest level on a table with the palm facing up. Make sure that the cuff is properly adjusted, but not too tight and touching bare skin, before starting the blood pressure measurement. The person being tested should not speak during this procedure to ensure an accurate and reliable measurement. An initial measurement will be taken on each arm to determine the arm with the highest blood pressure. Three measurements will be then taken at least one minute apart. The unit measure is: Millimetre of mercury (mmHg)
Spirometry
时间窗: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
An expiratory flow meter (Datospir Peak-10, Sibelmed S.A.U, Barcelona, Spain) will be used to measure peak expiratory flow. The maneuver is performed in a seated position with both feet resting on the floor, the head in a neutral position and a nose clip is used. The participant will be instructed to perform a maximal inhalation followed by a rapid exhalation, with an expiratory effort of 1 to 2 seconds. The patient will be instructed not to cough during the technique and not to flex and/or extend the cervical spine. Three maneuvers will be performed, with the highest value being used for the analysis. Measurement will be given in liter per minute (l/min).
Oxygen saturation
时间窗: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
A Beurer PO30 pulse oximeter (Beurer GmbH, Mittelstand, Germany) will be used and placed on the index or middle finger previously cleaned with alcohol. Participants are asked not to apply nail polish to their fingernails. Measurement results will be given in percentage of oxygen saturation (%SatO2)
Bioimpedance
时间窗: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
The NUTRILAB BIA 101 BIVA® PRO bioimpedance device (AKERN Srl, Florence, Italy) will be used. This non-invasive method measures the body's resistance and reactance of the body to the passage of a low-intensity electric current and enables the determination of various body parameters. Bioimpedance provides accurate data on body fat percentage, muscle mass, total body water and other relevant indicators such as phase angle and Z-score. Users will be instructed to remove all metal-containing objects and remain in a supine position on a couch during the measurements, with the legs in 45° abduction, the shoulders in 30° abduction relative to the center of the body and the hands in pronation. After cleaning the skin with alcohol, two adhesive electrodes (Biatrodes Akern Srl, Florence, Italy) will be placed on the surface of the right hand and two on the right foot. The measurement results will be given in different unit measures depending on the specific variable assessed.
Nutritional assessment
时间窗: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
* Mini-Nutritional Assessment (MNA): is a screening tool that helps to identify malnourished older people or those at risk of malnutrition. It assesses 17 items and consists of two main sections, a screening and an overall assessment. The maximum total score is 30 points, with higher scores indicating better nutritional status. * Malnutrition Universal Screening Tool (MUST): a five-step screening tool that assesses three variables (body mass index (BMI), weight loss in 3-6 months and the impact of acute illness) to identify malnourished adults, adults at risk of malnutrition (undernutrition) or obese adults. This tool is recommended by ESPEN for adults in the community, although it is also suitable for nursing home residents and hospital patients and can be used by all health professionals. This screening serves as a predictor of hospital admissions, mortality and associated costs.
Handgrip strength
时间窗: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)
Handgrip strength will be assessed using the hand-held Jamar® Plus Smart Dynamometer (Patterson Medical Ltd., Sammons Preston, Nottinghamshire, UK). Manual grip strength will be recorded on both limbs and the dynamometer will be adjusted to hand size prior to testing. The participant's elbow should be in 90° flexion, the forearm is fully supported on a rigid surface (stretcher or table) and the shoulder is in a neutral position. Participants will be instructed to keep the flexion and extension of the wrist neutral. Three measurements will be taken with a one-minute break in between and the best one is used for the analysis. Measurements will be given in kilograms.
Short Physical Performance Battery (SPPB)
时间窗: Visits 1, 2, 3 and 4
is an instrument to assess the risk of frailty and the risk of falls. This test consists of three tests: a) balance tests; b) 4-meter walking speed; c) five-times stand-up and sit-down test (5STS). In the balance tests, participants will be asked to stand with their feet side by side for 10 seconds, then advance to walk in a half-tandem position for 10 seconds and finally to walk in a tandem position for 10 seconds or longer. For gait speed scoring, participants will be instructed to complete two 4-meter walks at their normal pace, with the faster of the two times being recorded for scoring. For the 5STS, participants are asked to cross their arms over their chest and stand and sit on a chair five times as fast as possible. Each item will be scored on a scale of 0 to 4 points, with a possible total possible score of 12 points, with higher scores indicating better physical performance.
次要结局
- Frailty phenotype(Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7))
- Sarcopenia detection(Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7))