NCT06974006

Life Monitoring for Rural Older Adults

Integrated Monitoring for Independent Living in Rural Settings

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 82 (estimated)
• Sponsor: European University Miguel de Cervantes · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Aged 60 Years or Older

Interventions

Type	Name	Description
OTHER	Devices: Kardia Mobile 6L; Omron M7 BP ; Beurer PO30; Datospir Peak-10; NUTRILAB BIA 101 BIVA® PRO; JAMAR® Smart.	Use of the Kardia Mobile 6L portable device to assess electrocardiogram; Omron M7 BP for blood pressure; Beurer PO30 for oxygen saturation; Datospir Peak-10 for peak flow; NUTRILAB BIA 101 BIVA® PRO for body composition; questionnaires for the nutritional status (Mini-Nutritional Assessment, Malnutrition Universal Screening Tool), JAMAR® Smart for handgrip strength; The Short Physical Performance Battery for frailty status and fall risk; the Geriatric Depression Scale to evaluate depression status; the Fried's frailty phenotype to assess the frailty status; the International Physical Activity Questionnaire for the physical activity levels; SARC-F to identify older adults at risk of sarcopenia; and the Timed-Up and Go for mobility, walking ability and fall risk.

Timeline

• Start date: 2025-05-15
• Primary completion: 2026-12-30
• Completion: 2027-01-15
• First posted: 2025-05-15
• Last updated: 2026-03-09

Locations

2 sites across 1 country: Spain