Life Monitoring for Rural Older Adults

Official title

Integrated Monitoring for Independent Living in Rural Settings

Overview

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.

Interventions

• 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 stat

Primary outcome measures

• Electrocardiogram (ECG) [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Blood pressure [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Oxygen saturation [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Spirometry [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Bioimpedance [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Nutritional assessment [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Handgrip strength [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Short Physical Performance Battery (SPPB) [Time frame: Visits 1, 2, 3 and 4]

Secondary outcome measures (2)

• Frailty phenotype [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]
• Sarcopenia detection [Time frame: Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)]

Eligibility criteria

Inclusion criteria

• People living in rural areas of less than 20,000 inhabitants belonging to the Diputación de Valladolid.
• People aged 60 years or older.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Spain · 2 centers

• Miguel de Cervantes European University — Valladolid
• Miguel de Cervantes European University — Valladolid

Publications

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48( PMID 30312372
• Roman Vinas B, Ribas Barba L, Ngo J, Serra Majem L. [Validity of the international physical activity questionnaire in the Catalan population (Spain)]. Gac Sanit. 2013 May-Jun;27(3):254-7. doi: 10.1016/j.gaceta.2012.05.013. Epub 2012 Oct 24. Spanish. PMID 23103093
• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. PMID 11253156
• Ortega Orcos R, Salinero Fort MA, Kazemzadeh Khajoui A, Vidal Aparicio S, de Dios del Valle R. [Validation of 5 and 15 items Spanish version of the geriatric depression scale in elderly subjects in primary health care setting]. Rev Clin Esp. 2007 Dec;207(11):559-62. doi: 10.1157/13111585. Spanish. PMID 18021644
• Kameniar K, Mackintosh S, Van Kessel G, Kumar S. The Psychometric Properties of the Short Physical Performance Battery to Assess Physical Performance in Older Adults: A Systematic Review. J Geriatr Phys Ther. 2024 Jan-Mar 01;47(1):43-54. doi: 10.1519/JPT.0000000000000337. Epub 2022 Apr 19. PMID 35442231
• Guigoz Y, Vellas B. Nutritional Assessment in Older Adults : MNA(R) 25 years of a Screening Tool and a Reference Standard for Care and Research; What Next? J Nutr Health Aging. 2021;25(4):528-583. doi: 10.1007/s12603-021-1601-y. PMID 33786572
• Campa F, Bongiovanni T, Rossi A, Cerullo G, Casolo A, Martera G, Trecroci A, Moro T, Paoli A. Athletic bioimpedance-based equations underestimate fat free mass components in male elite soccer players: development and validation of new soccer-specific predictive models. J Transl Med. 2023 Dec 15;21(1):912. doi: 10.1186/s12967-023-04795-z. PMID 38102652
• Magave JA, Bezerra SJS, Matos AP, Pinto ACPN, Pegorari MS, Ohara DG. Peak Expiratory Flow as an Index of Frailty Syndrome in Older Adults: A Cross-Sectional Study. J Nutr Health Aging. 2020;24(9):993-998. doi: 10.1007/s12603-020-1423-3. PMID 33155627

Identifiers

NCT: NCT06974006 · PI-DOC009-VIVIR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗