SBIR-STTR Award

The Cells and Surveys report (National Research Council 2000) reports that collecting biological information dramatically improves the value of household surveys by adding a rich dataset of information to longitudinal databases that is not collected today. In fact, since the Cells and Surveys report the collection of biological data and performance measures (in addition to demographic, socioeconomic, cognitive, attitudinal and health data) from individuals in household surveys have become increasingly common. Such data is not only of use to academic researchers, but to insurers, health care providers, HMOs, pharmaceutical companies and health and wellness policy analysts. Specific advantages of having rich data sets include 1) Ability to easily conduct population-based comparison research looking for such differences such as healthcare outcome disparities 2) Having such data readily accessible enables an entirely new paradigm of future research such as Bio-demography 3) Enables future studies in a matter of hours versus months or years 4) Enhances research into population level effects of behavioral interventions, new health care initiatives and environmental factors (physical, chemical or biological). The proposed wearable monitoring system to be studied in Phase I is anticipated to enable longitudinal (weeks to years) data to be collected with greater ease. This proposal is to determine the design and feasibility wearable monitoring for population-based aging research surveys. It is fully responsive to PA-06-471 with a non-intrusive (or non-obtrusive) wireless data collection system to increase the portability, speed, ease and cost-effectiveness of collecting biological data and performance measures in household surveys. The proposed system includes the following components: 1. A wearable, non-intrusive (wrist watch type), wireless device for the collection of physiological and environmental event data specifically tailored for aging research. The device is intended to be worn continuously for a set period of time after the initial interview. 2. A portable wireless connection system (PANDA - Powered Automated Network Data Aggregator) for the wearable device to securely and wirelessly communicate its data to remote servers. The device will also store data if a connection to a remote database server is not available. 3. A new paradigm for an elderly user interface via `surface computing' touch screens via a mobile, Apple iPhone to support easier mobile subject interaction anytime, anywhere in answering survey questions and providing alerts to the subject. 4. A data storage capability and data query software that runs on the remote server. This part of the system integrates the wireless physiological and environmental data with all other data streams collected. It performs the data management and transfers integrated records to the remote longitudinal database from anywhere at anytime using distributed, secure network computing via the Internet. This Phase I proposal is made in collaboration with a senior researcher in the field, Dr. Neil Charness, Professor of Psychology, Florida State University. The scope of initial `mobile' data to be collected in real-time includes Pulse Oximetry, Heart Rate, Skin temperature, movement/gait analysis and a questionnaire. Upon establishing the platform, external third-party devices for additional biomarker or environmental sensor data collection can be supported using standards-based open interfaces. This expanded set of data could include electrical physiological data (ECG, EEG), blood spot assay measures, reaction time assessments, sense function assessments (visual, olfactory, auditory, etc.), strength assessments, mobility/function assessments, and any future devices that will be developed. AFrame has developed a prototype end-to-end wearable system that includes a wrist sensor (fall detection, location information, pulse oximetry/heart rate, skin temperature, ambient temperature and software settable buttons - panic, etc.), a PANDA gateway and advanced analytic (Bayesian) remote server software that processes the real-time event data. Bluetooth connectivity is being added to support receipt of blood glucose measurements and weight scale data. The system is slated for commercial use in eldercare health monitoring applications starting in the second half of 2008. It is proposed that adaptations to the system including direct user interface data capture of questionnaires and expanded data capture will be of value to aging survey based research.

Public Health Relevance:
This project supports the collection of data in longitudinal surveys of the elderly. The project is fully responsive to PA-06-471. The project supports the public health mission of the National Institutes of Health, specifically the National Institute of Aging by supporting the NIA's mission to improve the health and well-being of older Americans through research.

Public Health Relevance Statement:
PROJECT NARRTIVE This project supports the collection of data in longitudinal surveys of the elderly. The project is fully responsive to PA-06-471. The project supports the public health mission of the National Institutes of Health, specifically the National Institute of Aging by supporting the NIA's mission to improve the health and well-being of older Americans through research.

Project Terms:
Age Group Unspecified; Aged 65 and Over; Aging; American; Apple; Assay; Auditory; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior or Life Style Modifications; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Bioassay; Biologic Assays; Biological; Biological Assay; Blood; Blood Glucose; Blood Sugar; Care, Health; Cells; Chemicals; Chronotropism, Cardiac; Chronotropisms, Cardiac; Clinical Trials; Clinical Trials, Phase II; Clinical Trials, Unspecified; Cognitive; Collaborations; Collection; Computer Programs; Computer software; Conditioning Therapy; Data; Data Banks; Data Bases; Data Collection; Data Set; Data Storage and Retrieval; Databank, Electronic; Databanks; Database, Electronic; Databases; Dataset; Detection; Devices; Drops; ECG; EEG; EKG; Effectiveness; Elderly; Elderly, over 65; Electrocardiogram; Electrocardiography; Electroencephalography; Energy Expenditure; Energy Metabolism; Ensure; Environmental Factor; Environmental Risk Factor; Event; Examination of gait; Florida; Funding; Future; Gait; Gait Analysis; Goals; Grips; Health; Health Care Providers; Health Personnel; Healthcare; Healthcare Providers; Healthcare worker; Hearing; Heart Rate; Hour; Household; Human; Human, General; Individual; Institutes; Insurance Carriers; Insurers; Internet; Interview; Investigators; Life Style Modification; Location; Longitudinal Studies; Longitudinal Surveys; Man (Taxonomy); Man, Modern; Measures; Mission; Monitor; Movement; NIH; National Institutes of Health; National Institutes of Health (U.S.); National Research Council; National Research Council (U.S.); Outcome; Panic; Paper; Participant; Performance; Personal Satisfaction; Pharmaceutical Agent; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Phase; Phase 2 Clinical Trials; Phase II Clinical Trials; Physiologic; Physiological; Policies; Population; Process; Psychology; Public Health; Publishing; Pulse Oximetry; Questionnaires; Reaction Time; Records; Recruitment Activity; Reporting; Research; Research Personnel; Researchers; Response RT; Response Time; Reticuloendothelial System, Blood; Running; Secure; Senescence; Skin Temperature; Software; Speed; Speed (motion); Spottings; Stream; Surface; Survey Instrument; Surveys; System; System, LOINC Axis 4; Target Populations; Temperature; Testing; Time; United States National Institutes of Health; Universities; Visual; WWW; Weight; Weight measurement scales; Wireless Technology; Work; Wrist; advanced age; age group; base; behavior intervention; behavioral intervention; biomarker; body movement; clinical data repository; clinical data warehouse; clinical investigation; computer program/software; cost; cost effectiveness; data management; data repository; data retrieval; data storage; design; designing; discovery mining; elders; environmental risk; experiment; experimental research; experimental study; falls; gait examination; geriatric; grasp; health care personnel; health care worker; health provider; healthcare personnel; hearing perception; improved; innovate; innovation; innovative; late life; later life; literature mining; literature searching; long-term study; longitudinal database; medical personnel; meter; novel; older adult; older person; phase 2 study; phase 2 trial; phase II trial; population based; portability; professor; protocol, phase II; prototype; psychomotor reaction time; public health medicine (field); public health relevance; recruit; relational database; research study; response; senescent; senior citizen; sensor; socioeconomic; socioeconomically; socioeconomics; sound perception; study, phase II; success; text mining; text searching; tool; touch panel; touch screen; touch screen panel; touchscreen; touchscreen panel; treatment provider; web; well-being; wireless; world wide web

As the percentage of the U.S. population aged 65 and older grows from the 12.9 percent reported in 2009 to the estimated 19 percent projected in 20301, it is becoming increasingly important that the many factors affecting the health and well being of this portion of the population are understood and addressed. Methods of surveying this population and gathering longitudinal data regarding aspects of their lives, such as activity level sleep patterns, physiological data, and behavior patterns are needed and have been highlighted as an area of interest by the National Institute of Aging. Such data are not only useful to academic researchers, but to insurers, health care providers, health and health policy analysts and, on a more intimate level, by caregivers. However, cost and adherence play key roles in the ability to collect such data, so an easy-to-use, low-cost automatic data collection system is required;one which can and will be utilized by the elderly on a regular basis and which is capable of capturing a wide range of key health indicators. This Phase II application aims to demonstrate the effectiveness of a portable and real-time survey system capable of collecting activity level, location, and sleep patterns on a continual basis from a wrist-based device in a watch form factor, as well as physiological data such as blood pressure and weight from easy-to-use wireless devices, and self-reported data from easy, touch-screen interfaces regarding a number of varying topics including pain level, diet and nutrition, or stress. The application aims to prove the following hypothesis: The proposed monitoring system provides an effective means of collecting real-time survey data (including physiological, activity, sleep, and self- report dat) from elderly individuals for an extended period of time and is capable of recognizing deviations from individualized baseline norms that could be indicative of illness or need for intervention. During the study, 30 reasonably healthy elderly individuals and 60 elderly individuals with congestive heart failure (CHF) will be monitored over six months, during which a number of episodes of acute CHF exacerbation are expected to occur;the system will learn to recognize and alert upon such episodes. CHF was chosen so that the effectiveness of the system in flagging deviations from an individual's system-learned baseline could be better demonstrated. All study participants will be monitored by a visiting nurse/physician once each week. Moreover, 30 of the CHF participants and the 30 other participants will also be monitored using the proposed system configured to provide real-time data to the nurse in charge of each participant. The specific aims of the project will be to establish that: 1) the platform can and will be used by an elderly population for an extended (six-month) period of time, 2) the watch device is effective for collecting longitudinal sleep and activity data, and 3) the system is effective in providing useful survey data to monitoring nurses while reducing the burden of care.

Public Health Relevance:
As the percentage of the U.S. population aged 65 and older grows from the 12.9 percent reported in 2009 to the estimated 19 percent projected in 20301, it is becoming increasingly important that the many factors affecting the health and well being of this portion of the population are understood and addressed. Methods of surveying this population and gathering longitudinal data regarding many aspects of their lives, such as activity level, sleep patterns, physiological data, and behavior patterns are needed and have been highlighted as an area of interest by the National Institute of Aging. The monitoring system proposed for evaluation during this Phase II study is expected to provide an effective means of easily collecting real-time survey (including physiological, activity, sleep and self-report) data from elderly individuals for an extended period of time as well as automatically recognize deviations from individualized baseline norms indicating the possibility of illness or need for intervention.