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Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
Published on: July 27, 2018
Leveraging Digital Health Technologies to Assess Older Adults' Frailty and Nutritional Status: Two Cross-Sectional
Nunzio Camerlingo1, Madisen Wicker2, Dimitrios J Psaltos1
1Pfizer (United States), Cambridge, MA, United States.
Background:
With the rising prevalence of aging worldwide, there is a necessity for reliable and frequent assessments of older individuals' health status to manage and potentially prevent age-related complications. Digital health technologies (DHTs), such as wearable devices, provide an opportunity to gather objective, continuous, and unobtrusive measurements, enabling effective health management in everyday life.
Objective:
We aimed to evaluate the relationship between digital endpoints and frailty, nutritional status, and patient-reported outcomes (PROs) in older individuals, as well as quantified their compliance and comfort with DHTs.
Methods:
In two cross-sectional studies, namely the Geriatric Anorexia Studies 1 and 2, including three in-clinic visits and 2-3 weeks of at-home monitoring, 94 participants (mean age 72.98 years, SD 6.28 years) were stratified based on their frailty status (n=39, 41%, nonfrail; n=45, 48%, prefrail; and n=10, 11%, frail) and nutritional status (n=70, 74%, with normal nutrition and n=24, 26%, at risk for malnutrition), as assessed in a clinical setting using the Fried Frailty Score and the Simplified Nutritional Appetite Questionnaire, respectively. We remotely monitored older adults using different DHTs. At home, participants were monitored with a wrist accelerometer for physical activity, continuous glucose monitoring (CGM) for glucose concentration, a digital body scale for weight and body composition, and a digital nutritional scale for meal tracking. Compliance with devices was assessed via wear time and correct at-home usage, while comfort was evaluated using questionnaires. The association between digital endpoints and frailty/nutritional status was investigated via linear regression, followed by ANOVA, and the relationship between digital endpoints collected at home and PROs was evaluated via Spearman's ρ. Weight and body composition were also assessed during in-clinic visits with a research-grade scale, used to validate the at-home digital body scale measurements, via the intraclass correlation coefficient, Pearson's R, and Bland-Altman plots with mean bias.
Results:
Physical activity digital endpoints collected at home were significantly different across frailty and nutritional groups and significantly correlated with self-reported appetite, fatigue, and physical function (eg, for mean daily activity in the maximum 60 minutes of activity, ρ=0.28, -0.23, and 0.47, respectively). More than 80% of participants reported that all devices were mostly to very acceptable to wear/use: 95% (88/93) for the body scale, 86% (43/50) for CGM, 80% (40/50) for the nutrition scale, and 91% (84/93) for the wrist accelerometer. Compliance ranged from 60% of monitoring days for the digital nutrition scale to 90% for the wrist accelerometer.
Conclusions:
Physical activity digital endpoints show clear prognostic significance for frailty and malnutrition in older individuals and reflect self-reported measures. DHTs can be reliably deployed at home for older individuals to measure their physical activity, weight and body composition, glucose concentration, and meal intakes, thus enabling patient-centric, data-centric clinical trials.
Trial Registration:
ClinicalTrials.gov NCT04858932; https://clinicaltrials.gov/study/NCT04858932; ClinicalTrials.gov NCT05211973; https://clinicaltrials.gov/study/NCT05211973.
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