Life Monitoring for Rural Older Adults
ConditionAged 60 Years or Older
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorEuropean University Miguel de Cervantes
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
People living in rural areas of less than 20,000 inhabitants belonging to the Diputación de Valladolid.
People aged 60 years or older.
Disqualifiers
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.
Trial population
Older adults (≥60 years old) with or without chronic diseases living in rural areas of Valladolid
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Devices: Kardia Mobile 6L; Omron M7 BP ; Beurer PO30; Datospir Peak-10; NUTRILAB BIA 101 BIVA® PRO; JAMAR® Smart.
Other interventionUse 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.
Treatment groups
82 Participants
are divided into 1 treatment groupGroup A: Older adults living in rural areas1 intervention
Trial outcomes
Primary outcomes
1
Electrocardiogram (ECG)
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.)
Time frame
Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)2
Blood pressure
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)
Time frame
Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)3
Oxygen saturation
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)
Time frame
Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)4
Spirometry
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).
Time frame
Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)Secondary outcomes
1
Frailty phenotype
The Fried frailty phenotype will be used to assess frailty status, which is composed of five main components: i) involuntary weight loss; ii) fatigue or exhaustion; iii) weakness; iv) walking speed; v) physical activity levels. Within this tool and with the intention of assessing physical activity levels, the International Physical Activity Questionnaire (IPAQ) will be used. This questionnaire consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) performed in the last seven days, as well as walking and sitting time in a working day. This tool allows a standardized and valid measurement of physical activity and is useful in both research and public health. Measurements will be given in a global score (0-5).
Time frame
Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)2
Sarcopenia detection
The risk of sarcopenia will be assessed using the most updated criteria of the European Working Group on Sarcopenia in the Elderly (EWGSOP 2). Following the algorithm proposed by them, the following assessments will be performed: * SARC-F: this five-question questionnaire will be used to identify subjects at risk of sarcopenia. * Manual grip strength: using the protocol previously described. * Five times sit-to-stand test: this is included in the SPPB. * Appendicular muscle mass: will be identified through bioimpedance performed through the protocol described above. * Gait speed. Measurements will be given in a total score and the specific results obtained in each assessment (kilograms for handgrip assessment, time (seconds) for five times sit-to-stand, total appendicular muscle mass; velocity (m/s) for gait speed; and time (seconds) for Timed Up and Go).
Time frame
Visits 1 (Month 1), 2 (Month 2), 3 (Month 3) and 4 (Month 7)Other outcomes
1
Telephone follow-up
This will be carried out every two weeks during the seven months of the study using a semi-structured interview to record the number of cardiovascular events, hospitalizations and falls of each participant. All measurements will be taken during the monthly evaluations scheduled for the first three months and seven months after the start of the study.
Time frame
Phone calls every two weeks during the seven months of studySponsors and contacts
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Source ClinicalTrials.gov