Patent ID: 12217861

DETAILED DESCRIPTION OF THE INVENTION

A description of example embodiments of the invention follows.

The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety.

An example embodiment of a Coordinated Care System (CCS)100, shown inFIG.1, includes a patient wearable device (PWD)102, a caregiver mobile app104, and a webserver106. The caregiver mobile app104runs on a commercially-available platform such as a smartphone or electronic tablet. The webserver106, which runs on a commercially-available platform such as a computer system or workstation, implements a coordinated care platform that seamlessly integrates the PWD, the caregiver mobile app, the webserver, and various third party providers (such as pharmacies and healthcare providers). The webserver106includes a web frontend, a server backend, a backend database and an application program interface (API). Target users for each of these components are shown in Table I.

TABLE IComponentTarget UserPatient Wearable Device (PWD)PatientSmartphone or TabletNurse/Caregivers, Family members,application (CaregiverPhysicians, Medical Coordinators,Mobile App)among othersWebserver, backend applicationFamily members, Physicians, Hospitals,with a web frontendPharmacy, Caregivers, among others

The software stack technologies for the CCS components and sub-components are shown in Table II.

TABLE IIComponentTechnologyTarget UserHosted/Runs OnPWDAndroidPatientPWD hardwareMobileAndroid,CaregiverCaregiver's mobileAppiOSdevice (smartphoneor tablet)ServerJava,CSS AdminsGoogle App EngineBackendHibernateWebHTML5,Medical Staff,Google App EngineFrontendCSS3Admin, PhysiciansBackendGoogleCSS AdminsGoogle App EngineDatabaseCloudSQLAPIJavaMobile apps,Google App EngineFrontend, Pharmacyintegration
Patient Wearable Device (PWD)

As described below, the PWD102supports cellular communications, which enables connection to the webserver106through mobile Internet. A SIM card within the PWD102is associated with a voice and data plan activated for calls with caregivers and selected family members. As the PWD connects to the webserver106using cellular data service, there is no need for external/additional controller, hub or a smartphone in the patient's home or carried by the patient for the PWD to connect to the internet. The PWD is fully functional by itself, and can therefore be used anywhere inside or outside the home, as long as cellular connectivity is available.

The PWD is water resistant with Ingress Protection (IP) IP67 or IP68 certification, so it can be used in the shower, kitchen or rain, even while travelling or sleeping. The first digit 6 in IP67 implies that it is dust proof and the second digit 7 implies water resistant and 8 implies water proof. These certifications are provided International Electrotechnical Commission (IEC) based on tests, and show that the device has proper sealing and enclosures to protect from dust or water.

Patients using the PWD are expected to be seniors typically 70 years or older. In one embodiment, the PWD and its patient interface may be developed with characteristics specifically targeted for this age group to accommodate their attendant vision and dexterity issues.

As shown inFIG.2, an example embodiment of the PWD102may include a Central Processing Unit (CPU)202, Graphical Processor Unit (GPU)204, and a touch-sensitive display205. The display205is capable of presenting configurable color schemes that optimizes the visual effect experienced by the patient. In some embodiments, the screen is relatively large (e.g., 1.5 inches by 1.5 inches). Displayed text font is generally large and bold so that elderly patients will have an easier time reading the text. As described herein, patients may respond to medication reminders by tapping the display screen. For such responses, the user can tap the display screen at any point on the surface of the display screen, rather than a specific sub-region of the screen.

The PWD102may also include a cellular modem module206, supporting, for example LTE protocols, 3GPP protocols, GSM/EDGE protocols, combinations thereof, or other wireless wide area communication protocols. The cellular modem206coordinates with an RF interface208for connection to a cellular wireless network.

The PWD may also include a Global Navigation Satellite System/Global Positioning System (GNSS/GPS) module210to determine the position of the PWD102based on satellite communication, although other positioning systems known in the art may also be used. The PWD102may also include audio and video CODECs212for encoding and decoding voice and video information. The PWD102may also include a multi-media processor214for supporting PWD activities such as voice calls, PWD activation, video calls, playing video, among others.

A sensor hub216manages and collects data from one or more sensors (e.g., an accelerometer, a magnetometer, a motion sensor, a gyroscope, a stress/strain sensor, and a pressure sensor, among other types of sensors know in the art). The sensor hub216samples data from the one or more sensors and stores the collected information in memory232. Software or firmware, stored in memory232and executed by the CPU202, may cause data to be extracted from the memory232, assembled into a predetermined format, and sent to the back-end server within the CCS for various types of processing, such as the Early Warning Predictive Analysis (EWPA) described herein. The sensor hub216may be implemented by a processor running instruction code, a collection of analog and digital circuitry, or a combination of both.

The PWD memory232may also be used to implement a database to store medication regimen, instructions and messages. In an example embodiment, the following attributes may be stored for each medicine:Timeslot (i.e., times when the patient takes Breakfast, lunch, snack, dinner, wake up time and bed time)Medicine nameDosage (quantity—e.g., two tablets, one capsule, one-half fluid ounce)To be taken before or after foodDays of week (e.g., every day, every other day, once per week)Image information for depicting/displaying the medicineVoice instructions

In one example embodiment, the memory232is approximately 4 GB. The memory232may be implemented in a single memory component, or distributed across two or more memory components. The information that needs to be stored is less than 1 GB including, the medicine image information. Having a local storage in the PWD102also helps in delivering the reminders consistently while reducing the risk of failure due to a communication outage between the PWD102and the webserver106. Thus, once the medication details are downloaded to the PWD102, the PWD102may operate substantially autonomously, without requiring constant supporting communication with the webserver106.

The main functionality of the PWD is implemented with a PWD app. In one embodiment, the PWD app is instruction code, stored in the memory232and executed by CPU202. In one embodiment, the PWD app is a dedicated (kiosk mode with root access) application using Andriod OS and Andriod application framework. The term “dedicated” as used herein implies that there are no other applications running on the watch and the user need not navigate through any menus or apps.

To send “medication taken” status, alerts, behavioral data points, and other such information, however, the PWD102does communicate with the webserver106to some extent. The watch communicates using JAVA REST APIs to the webserver106. Such communications may be done in the background, without interfering with the PWD's regular functions such as providing medication reminders and collecting behavior data points. In some embodiments, the webserver106may periodically check the health of the PWD102, and the status of its communication capabilities, by executing diagnostic tests. Such diagnostic tests may be executed external to the PWD102(e.g., by sending test messages from the webserver106to the PWD and requiring specific responses), internal to the PWD (e.g., test instructions stored within the PWD memory232and executed by a PWD processor).

In addition, the PWD102supports a subscriber identification module (SIM)218for designating phone and data service subscriptions, a near-field communication (NFC) module220for reading and processing NFC tags, one or more audio drivers221and speakers222for producing audible sounds, one or more microphones224for receiving audible sound and transducing the sound into an electrical signal, a vibration module226for providing haptic notifications, one or more cameras228and a real time clock (RTC)230that provides a chronometer function for date and time of day (i.e., the PWD functions as a wrist watch). The PWD may further include local communications elements such as a Bluetooth transceiver234and a WiFi transceiver236. Other communications protocols (e.g., Zigbee) may also be used.

The PWD102may also include an energy storage element (e.g., a lithium-ion battery or other re-chargeable battery type) and associated recharging circuitry238for efficiently recharging the energy storage element. Some embodiments provide for an electrical connection of the PWD102to a charging unit through electrically conducting contacts. Other embodiments provide for inductive coupling of the PWD102to a charging unit.

Information from the patient (e.g., responses to medication reminders) may be provided to the PWD102through the touch-sensitive display screen205, or through other input/output (I/O) components240, for example push-buttons, sliding switches, and other I/O components known in the art.

In one embodiment, all of the components of the PWD102may be implemented by a commercially-available single System On a Chip (SoC) solution. In other embodiments, the functionality may be implemented by a custom-designed device (i.e., ASIC) or chipset, or as combinations of both a commercially-available SoC and custom designed components.

Interaction between the PWD and the patient (i.e., the PWD user interface) is simple. There is no patient-involved setup required for the PWD, as the set up will be completed by the caregiver using the caregiver mobile app (described later herein) or by the pharmacist once the pharmacy is integrated with the CCS.

Activation of the PWD may also be done by the caregiver using the caregiver mobile app. The PWD downloads the complete medication regimen when the PWD is powered on, and the patient can start wearing the PWD once activated. Typically the only action required by the patient is to acknowledge an instruction by performing a single tap anywhere on the display screen. Many aspects of the user interface, including the voice, display and the vibrations, can be customized remotely from caregiver mobile app.

An example embodiment of a PWD constructed according to the invention, with various screenshots, features and PWD app architecture, is shown inFIG.3. As shown, the PWD has a local database where the medication regimen, images, and voice files are stored. The local processor activates reminders based on a scheduler, and stores responses from the patient. When the reminders are completed, the PWD sends an alert or log to the coordinated care platform at the webserver, including all the medications taken and missed, along with the time sequence information associated with the responses. The PWD may communicate with the coordinated care platform via JAVA REST APIs. For example a missed medication alert may have following information:

AlertID:

missedTimestamp:

patientID:

missedTimeSlot:

missedBeforeOrAfterFood:

missedMedicationIDs: [{medication detail 1}, {medication detail 2}, {medication detail 3}

Medication details may include, for example, medicine name and dosage, among other descriptive information. Since patientID is in the form of a control number, no name will be sent across.

FIG.4illustrates a functional block diagram of an example embodiment of the PWD102. An example embodiment of a PWD102may provide one or more of the functionalities described below.

Displaying Time of Day—This is the default image displayed by the display screen105. Time of day (TOD), as described herein, may include hours, minutes, seconds, month, day and year. The PWD may also speak the TOD when the patient taps the display screen (or otherwise indicates a desire to receive an audible version of the TOD). In some embodiments, the patient is able to modify the TOD setting only, with no other menus or navigation requirements.

Providing cellular telephone service—The PWD includes a cellular telephone that supports incoming and outgoing calls. In one embodiment, the PWD cellular telephone is implemented with a commercially available chip set such as the MediaTek 6753 or Qualcomm Snapdragon 2100. These chipsets may support one or more of 3GPP, LTE and GSM/EDGE protocols.

A SIM card is also provided for phone/data service. The SIM card is configured to include a set of preprogrammed telephone numbers and to accept calls only from those numbers. The PWD manages the incoming calls and outgoing calls from the PWD. In one embodiment, the patient is able to call pre-programmed family members by simply pushing a button on the side of the PWD. In one embodiment, a caregiver can program a sequence of telephone numbers and sequentially call each subsequent telephone number if the previous telephone number is not answered.

Providing Medication Reminders—With trio feedback (audio/visual/haptic), the PWD100may vibrate, beep and display a “Reminder” screen according to the patient's medication dosing schedule, although other embodiments may present alternative haptic, audio and/or visual stimuli. In response to an acknowledgement from the patient (i.e., the patient tapping the touch-sensitive display screen105or pressing a button, depending on the embodiment used), medications are displayed on the display screen105one by one, with brand and medication name, medication dosage and strength, an image of the medication, and a voice prompt providing instructions associated with the medication (e.g., how the medication should be taken). If a pill pack with weekly slots is used instead of individual pill bottles, then the image and dosage instructions for the slot may be displayed.

In some embodiments, the voice prompt is customizable to any family member voice. Some patients, especially Alzheimer or Dementia patients, are accustomed to only a family member's voice, so that instructions presented in the family member's voice helps the patient in taking their medicines.

Once the medication is taken, the patient is required to confirm that the medicine has been taken by tapping on the display screen. If the patient does not confirm taking the medication, the PWD will provide three additional reminders, snooze for 10 minutes and repeat the above-described reminding process. These repeated reminders will continue for one hour (or per physician's′ instructions). If even one medication is missed, a missed medication alert listing the missed medicines is generated and sent to the coordinated care platform at the webserver. The flowchart shown inFIG.5describes one embodiment of an example medication reminder process.

FIG.6provides the example screen shots of a PWD displaying medication reminder and battery charging reminders. An initial reminder screen602initially alerts the patient to a medication dosing session, and begins the medication reminder sequence of events. In a first medication screen604, the PWD shows the medication name (Seroquel), an image of the pill (front and back), and dosage (400 mg—take 2). An alternative medication screen606shows a door from a pill pack (Thursday noon) and dosage (4 tablets). Reminder screen608shows the PWD displaying another reminder, this time indicating a family member (i.e., daughter). Alert screen610shows the PWD displaying a “low battery” alert, requesting the patient to recharge the PWD (i.e., “Charge Me!”), and notification screen612notifies the patient that the PWD has been fully charged and is ready to wear again.

When the patient taps the screen, timestamps associated with the taps are recorded and sent to the predictive analytics engine. If the intervals between taps are too short, an alert is raised to the caregiver to check if the patient has taken the scheduled medicines.

Receiving Reminders from Caregivers—Caregivers may be alerted when a patient does not respond to one or more of the scheduled medication reminders. The caregiver can use their mobile app to submit a subsequent reminder to the patient, call the patient, or both.

Providing Activities of Daily Living (ADL) Reminders—Some embodiments may provide reminders to the patient to perform daily activities. Seniors often forget to take their meals on time, drink water or exercise. Lack of water causes dehydration. Exercise is very important for fall prevention, lowering the risk of heart diseases, injury, and elevated blood pressure. Lack of exercise may also lead to increased joint pain. Further, some medications require specific instructions on when to eat food or drink additional water. In some assisted living facilities or independent living communities, the number of nurses to patient ratio is often very small and in general there is not enough nurses to personally remind patients to remind their activities.

The described embodiments provide a convenient way to remind the patient to perform ADLs. These reminder messages can be stored during setup while entering the patient schedule, and the PWD will display those messages on time and get a confirmation that the messages were read. This confirmation may be logged in an activities log, and caregivers can be notified through a status feed. The resulting ADL performance information can be added to behavioral information to be evaluated via the EWPA. For example, a patient that misses meals with increasing frequency may be suffering from worsening memory loss.

Providing Motivational Messages—An embodiment may provide a mechanism where any specialized motivational messages or instructions can be provided to the patient based on a therapy. These messages are displayed based on a schedule configured in the database. Embodiments may include daily motivational messages (with spoken voice playback) encouraging the patient to adhere to their medication schedule and/or treatment program

Conducting Real-time Check-In—Real-time, bidirectional communication to survey or check on a patient, such as “Are you doing okay today?” (R U OK) or “How many did you smoke today?”

The “R U OK” communication is designed for seniors who live alone at their homes. The PWD displays the “R U OK” message. If the patient does not answer, an alert is sent to the caregiver or other healthcare provider. The alert can contain additional information including if the PWD is worn, information on the patient's recent activity prior to the alert, and other engagement details.

Requesting HELP—The patient can tap on the PWD100to send a HELP message to caregivers, thereby requesting a phone call-back to the PWD100(or to an alternative line in the home). Some embodiments of the PWD100may require alternative or additional actions from the patient to reduce or avoid false alarms (e.g., double tap or triple tap, or tap followed by a button push).

Call Caregiver/family—By pressing the side button (for example), the patient can initiate a telephone call to the family (or first level responder), through the PWD cellular module106and RF interface108. As with the request for HELP, some embodiments of the PWD100may require alternative or additional actions from the patient to reduce or avoid false alarms.

Incoming Calls from caregiver or a set of preprogrammed numbers—The PWD allows authorized numbers (such as caregivers) to call the PWD directly. All other incoming or outgoing calls are blocked to limit potential misuse. Limiting incoming telephone calls may also serve as a comfort factor for the patient, since the patient can feel secure that he or she will not be bothered by annoying telemarketing callers or malicious/fraudulent callers.

Alarms for Low and Full Battery—The PWD lets the patient know, via vibrate, alarm and/or voice prompts, when the energy storage element (e.g. battery) is low, and that the patient should connect to a charger, or when charging is complete

Live GPS Tracking & Directions—A geo-fence may be defined (e.g., for early Alzheimer patients) such that if the patient wanders away from his/her home, the PWD detects, using built-in GPS, that the patient is beyond the defined geo-fencing region and alerts their caregiver with accurate location information. In one embodiment, the PWD evaluates its position periodically (e.g., every 15 minutes), and if the PWD moves beyond an established geo-fence, the PWD begins continuous tracking and sends alert to the caregiver along with location information. The tracking continues until the PWD is back within Geo fence range. If the patient plans to intentionally move beyond the geo-fence boundaries (e.g., for a visit to a healthcare provider), the caregiver can disable GPS tracking through the caregiver mobile app until the patient returns to the within the established geo-fence region.

Fall Detection and Emergency Calling—The PWD may detect, using positional sensor input, when a patient has fallen. In response to a detected fall, the PWD may initiate an emergency call to a local call center or to a caregiver. If the patient is able to communicate during the emergency call, the patient may be able to provide information as to subsequent steps. If the patient is not able to communicate, the local call center or caregiver follows a predetermined response protocol for sending help to the patient.

Vitals Collection: In some embodiments, the PWD provides a hub for collecting “vitals” information from devices such as blood glucose monitor, blood pressure monitor and heart rate monitor, and sends the collected data to the backend application of the webserver to report to physicians, hospitals or other healthcare providers. In some embodiments, the information may be collected periodically based on a frequency set in the database.

Patient Profile Manager—This module of the PWD app initializes the PWD database with patient profile information including medication regimen, reminders and other details. Once operational, any updates to the profile information is received and processed by this module.

Battery Alarms—The PWD periodically monitors the state of charge of its energy storage element (i.e., the PWD battery). When the levels reach below a predetermined threshold (e.g., 20%), the PWD provides an audible indication (e.g., beeps) along with a display of the current battery state of charge and a voice instruction to begin recharging the PWD. If the patient does not tap to confirm the recharging notice, the reminders may again be presented periodically, and an alert may also be sent to the caregiver. When the PWD is fully charged, or the PWD recharging source is removed from the PWD, a reminder is sent to the patient instructing him or her to once again wear the PWD. If the PWD is not worn after a few reminders, an alert is sent to the caregiver and the caregiver can call the patient from mobile app or take other action with the patient.

In other embodiments, the PWD may be a commercially available smartwatch, modified to provide the functionality described herein. The commercially available smartwatch may be modified either physically or by having specific apps written for it.

Caregiver Mobile App

The smartphone or tablet application is available for the caregivers and family members, among others, to be able to monitor and communicate in real-time with the patient through the PWD. It should be understood that the concepts described herein may be implemented with alternative components, e.g., a pendant or armband device instead of (or in addition to) the smartwatch. Similarly, the smartphone or tablet application may be implemented on any other platforms suitable for performing the functions and/or capabilities of the described embodiments.

Initial Setup

When the caregiver buys or otherwise initially acquires a PWD for use by a patient, the caregiver can download a caregiver app into their smartphone or tablet from an app store or other source and create an account. The caregiver may then register the patient through the caregiver app, and either enter medication details manually, or download prescription data from an associated pharmacy, provided the caregiver can provide the proper authorization and consent.

When the caregiver enters the medication details manually, they will be prompted to take pictures of the medicine and upload to the coordinated care platform. The caregiver app sequentially guides the caregiver to complete the registration. A caregiver can register and manage multiple patients (e.g., both parents).FIG.7illustrates an outline of an example setup procedure of a PWD according to an embodiment. Example caregiver app functionalities, which may be performed by the caregiver app and/or the CSS of the described embodiments, are presented below.

Status feed: The caregivers may receive regular feeds regarding the patient's status, including medication log and other activities such as food, water, exercise, deviation from normal behavior, and GPS tracking.

Alerts and notifications: The caregivers may receive one or more of the following alerts and notifications, which are intended as illustrative examples and are not meant to be limiting: (i) Missed Medication alert, (ii) GPS alert, (iii) Low battery alert, (iv) Watch idle/not worn, (v) Early Warning alerts, (vi) R U OK alert, and (vii) ADL alerts.

When the alerts are received, the caregiver can log in to the coordinated care platform through the caregiver mobile app and review details of the alert. If the review indicates an issue, the caregiver can either send text messages to PWD, or call the PWD, from the caregiver app.

Dashboard: the coordinated caregivers get reports on a weekly basis with details including medication adherence, activities, and R U OK responses. Following reports are provided via dashboard:

Medication adherence logs: number of missed medications in the past week, number of alerts generated for missed medications, number of as needed medications (such as ibuprofen or over the counter medicines), medication adherence trending.

ADL logs: number of missed reminders for food, exercise and water.

R U OK logs: Number of missed R U OK response alerts.

Deviation logs: Deviation or change from normal behavior/activities.

GPS logs: Number of GPS alerts.

Vitals logs: Number of times vitals (e.g., weight, body temperature, blood pressure, heart rate, blood glucose) collected.

Telephone logs: Phone call History and details.

Emergency logs: Number and characteristics of emergency alerts issued.

Webserver

The webserver106, shown inFIG.1, implements the coordinated care platform described herein. The webserver106includes a backend application and a web-based front end, each of which runs on a processor-based computer system suitable for hosting server software.

The backend application portion of the webserver processes the data sent from the PWD, compares the currently sent PWD data to historical PWD data, and computes one or more trending occurrences based on the comparison. If the backend application detects changes in the patient behavior, with respect to the patient's historical data, the backend generates alerts to caregiver mobile app or hospital dashboard. The coordinated care platform uses JAVA REST API to communicate with web frontend, the pharmacy, the PWD and the caregiver app. The coordinated care platform also uses Google Cloud Messaging (GCM) Service to send messages and alerts. Some embodiments of the coordinated care platform may provide one or more of the following functions:

PWD Management—Includes (i) coordination of the assignment and initialization of PWDs for patients, (ii) registration of PWDs and patients, (iii) the setup by caregivers, (iv) downloading medication information, (v) receiving alerts, (vi) assembling data for the real-time behavioral points that were collected by and sent from the PWD, among others. As described herein, in an example embodiment the number of real-time behavioral points collected by the PWD may exceed 250.

Interface to Caregiver App—Management of caregiver accounts, communication with caregiver app to notify of real-time status information, missed medication alerts, and emergency alerts, among other alerts.

Early Warning Predictive Analytics (EWPA)—Periodical Collection, real-time processing of behavioral points from seniors based on the engagement of the PWD, generation of alerts if anomalies detected from the normal behavioral pattern

Storage—some embodiments use a combination of relational (i.e., Structured Query Language—SQL) and Non Structured Query Language (NoSQL) database implementations to store patient profiles, medication regimen and file system to store images of all medications and behavioral data points collected from the patient.

Security—The implementation and maintenance of authentication, authorization and consent forms with respect to all components of the CCS, implementation of a HIPAA compliance platform, and executing verification procedures for caregiver login. Digital signatures such as XML DigSIg or JWT or images will be used for verifying authorization. Other security techniques known in the art may also be used.

Pharmacy Interface—Pharmacy and Electronic Health Records (EHR) interface for one-touch download of prescription information and setup of the PWD. The pharmacies have application programming interfaces (API) to access prescription information. The Fast Healthcare Interoperability Resources (FHIR) describes REST API to get prescription information from EHR. The coordinated care platform may be integrated with pharmacy APIs, so that a pharmacist can download the prescription information, from their pharmacy-based software to the PWD, by clicking “PWD setup” from an application available to the pharmacist (i.e., the pharmacist's access point into the CCS). The pharmacist's app may be a web-based application or an application that is downloaded to the pharmacist's computer platform. Alternatively, as described herein, a caregiver using a caregiver mobile app may coordinate, through the pharmacy, downloading of prescription information to the PWD.

Web Front End—Provides a web-based interface for caregiver login, registration, setup, weekly and on-demand dashboards, to name a few examples.

Real-Time Instrumentation Data and Predictive Analytics

The described embodiments merge the ambulatory assessment and intervention, Ecological Momentary Assessment (EMA) and Ecological Momentary Interventions (EMI), into a single device (PWD). The PWD, coupled with advanced sensors, enables meticulous real-time monitoring to measure a patient's engagement with their treatment and adherence to their medications, by capturing the following instrumentation variables:Battery level and time when watch was connected to, and taken out of, a charger.Watch movement—sensor output, such as accelerometer, gyroscope, and GPS values, captured periodically, for example every 15 minutes. Other sensor output may also be collectedTime when a reminder is displayed and time when the reminder is “auto-snoozed” and/or when patient acknowledges taking the medication associated with the reminder.Time when medication is displayed and time when it is confirmed as taken or missed.Time when a motivational message or survey question is displayed and time when responded.Time when patient requests for a HELP callback, when the call is received and its duration.Time when patient initiated or received a call to/from the medical staff and its duration

Each medication reminder may produce a significant number of behavioral data points to be collected. Medication regimens with several medications therefore multiply those data point quantities. Example medication reminder data points may include (i) time when reminder was displayed, (ii) time when the screen was tapped to listen to the medicine list, (iii) time when the message/display was read, (iv) duration the display was presented, (v) time when the confirmation was tapped, (vi) time when reminder was snoozed, (vii) time when the second reminder was displayed, (viii) time when second time the reminder was auto-snoozed, (ix) time when the third reminder was displayed, (x) time when the alert was sent to the backend

Movement of the patient wearing the PWD may also result in a substantial number of behavioral data points to be collected. For example, movement may produce the following data to be collected: (i) time when the patient wears the watch in the morning, (ii) time or times when there is a change in movement, (iii) start time for inactive period (rest, sleep), (iv) end time for inactive period, (v) start time for charging the PWD, (vi) end time for charging the PWD, (vii) start time for idle period (i.e., no movement), (viii) end time for idle period, (ix) start time for rapid movement (e.g., exercise), (x) end time for rapid movement (exercise), (xi) start time when the PWD is not worn by the patient (but is not on the charger), and (xii) time when the PWD is worn again.

Similar data points may be collected with respect to ADL reminders, RU OK responses, PWD cellular telephone usage, among others.

The coordinated care platform can analyze the collected data points to predict potential outcomes. For example, certain combinations of points may be associated with potentially dangerous situations. Examples of such combination of points that can trigger potential danger include: (i) long idle time during an active period, (ii) missing a medication reminder and/or PWD not being worn or being idle during medicine or meal time, (iii) long idle period after rest or nap time, and (iv) unusually long rapid movement period.

Connected Healthcare Platform

The CCS described herein may be used to provide a connected healthcare platform. This connected healthcare platform may connect seniors (i.e., elderly patients), in real-time, with caregivers such as family, physicians, providers and pharmacy. The CCS may alert the caregivers to any anomaly in seniors' health or behavior. The PWD features the following aspects related to a connected healthcare platform:

Medication Reminders & Alerts—to take meds on time, shows medication name, image and dosage with voice instructions, with alerts to clinic on any missed medications

Real-time Customizable Interventions—Occasional questions multiple times a day (such as YES/NO, side effects, pain levels) to assess patient's physical and emotional health

Patient Safety—fall detection, one-touch phone call to clinic, and water resistant (can be used in the shower or the kitchen)

Early Warning System—collects multiple real-time behavioral engagement and compliance data points every day to assess and alert on any unusual behavior and adverse events.

Real-time Vitals Monitoring—Bluetooth hub to connect to Bluetooth based vital sign monitors such as heart-rate, blood pressure, blood glucose, weight-scale

Activity Monitoring—Passively track behavior and environmental exposures in real-time with minimal burden on participants

Connected Ecosystem—to clinicians, emergency numbers and trial management system.

Big Data Insights in Real-time—the described embodiments include machine-learning predictive analytics that provide customizable real-time trends, insights and outliers into patient's daily and historical engagement/compliance, health/activity status and response to therapy.

Privacy & Security—HIPAA compliant, encrypted, de-identified database.

Predictive Analytics Early Warning System

As described herein, the PWD may collect a substantial number of real-time behavioral data points every day, to be analyzed by an Early Warning Predictive Analytics (EWPA) machine learning system within the coordinated care platform to alert the caregiver (via our mobile app) in case of any behavioral anomaly. The real-time measurements from the PWD are stored in the backend database. An EWPA predictive algorithm (and its associated model), based on weighted distribution, evaluates historical data trends, predicts the behavior of the patient based on a predetermined number of prior responses and assesses the trending of the patient's compliance. If the adherence decreases (or is tending towards decreased adherence), then a trigger is generated to send alerts to the caregiver to nudge the patient get back on track. The real-time data can be used to predict the patient's adherence behavior and alert nurses or physicians proactively for any timely intervention. Predictive analytics described herein use the real-time data points to calculate a “compliance index” and “engagement index” for each patient.

In some embodiments, the compliance index may be a function of the following values:

Idle time—(During day-time or active time) Use accelerometer readings from the PWD (when not charging) every 15 mins to check if the PWD is moving, or idle (e.g., left on a desk)—assumption is that if the PWD is moving, it is being used and not idle.

Number of Auto-snooze requested—Determine the number of times the patient requested auto-snooze (i.e., activated an appropriate response input to a particular reminder auto-snoozed (means no response) in a day, then aggregate over all days within a predetermined time interval.

Number of Alerts issued—As described in more detail elsewhere herein, if the patient does not respond to a medication reminder within a predetermined time interval, an alert is raised for missed medication. Determine the number of alerts issued within a predetermined time interval.

Charging time—Determine the amount of time the PWD was left on charger—The PWD notifies the patient (i.e., produces beeps) to indicate low charge, full charge, or other charge states, with voice announcement to take it out and wear

Battery dead time—Determine the amount of time the PWD remained without charge until it was fully charged and restarted.

In some embodiments, the engagement index may be a function of the following values:

Medication Reminder—Determine the amount of time elapsed between when the reminder was issued (e.g., displayed or sounded) to when the patient acknowledged the reminder. This determination may indicate if the patient is just dismissing the reminder without compliance, or actually taking the medication and then dismissing it.

Daily Motivational Messages and other Reminders—This relates to ADL messages or R U OK messages. Determine the amount of time elapsed between when the message was displayed to when the patient acknowledged the message. This determination may be used to gauge the patient's level of interest in reading the message.

Proof of reading—evaluate PWD position, based on sensor output (e.g., accelerometer, magnetometer, gyroscope, etc.) to see if the PWD has moved to a position or level that evidences the patient reading the PWD display.

FIG.8illustrates an example graph that displays potential actions with respect to combinations of compliance index values and engagement index values. For example, a combination of the compliance and engagement index falling in the darkly shaded region802indicates that it is time to generate an alert.

In one embodiment, the EWPA prediction uses Exponential Weighted Moving Average (EMA) formula for determining indices. The indices are determined every day. Then decreasing weighting is assigned to each datum exponentially, but never becoming zero. Continued decreasing of the EMA value may be indicative of a tendency to deviate from normal behavior.

In one embodiment, the EMA for a series Y may be calculated recursively:
S1=Y1, and fort>1,St=[α·Yt]+[(1−α)·S(t-1)]

The coefficient α, a constant smoothing factor between 0 and 1, represents the degree of weighting decrease. A higher α discounts older observations faster. Ytis the value at a time period t, and Stis the value of the EMA at any time t.

The EWPA prediction uses these indices (and its historical trends) to learn the patient's behavior and help predict and personalize the intervention during follow-up phone calls or in-person meetings.

In an illustrative example, assume that the compliance index maximum value is 10 and the engagement index maximum value is 10. If the collected behavioral data indicates that the patient takes their medicine each time and no alert is raised then the value of 10 is assigned for compliance. If the data indicates that the patient looks at the PWD, reads or hears the instructions, then the engagement index is assigned a value of 10. If the patient scores10for both it is great. If, however the patient starts missing medicines and alerts need to be raised, then the compliance value will be some value less than 10, which triggers an alert to be sent to the caregiver. The caregiver may respond to the alert, for example by calling or visiting the patient to determine possible remedial actions.

In another illustrative example, the patient takes their medicine at the first reminder prompt. After a while, the patient's responsiveness slips to require a second reminder (engagement index will be lower) each time. As more time goes by, the patient's responsiveness slips to third reminder. Now looking at historic behavior, the trend is to slowly miss the medicine. The reason could be that the patient is not interested in taking the medicine, or even not hearing or seeing the reminder. This could mean that the patient's health is slowly deteriorating. On the other hand, it could simply be that the patient is busy and knows the third reminder will come. In this case an alert is sent to the caregiver to respond appropriately to the potential non-compliance trending.

Another illustrative example is based on engagement index. In this example, the accelerometer readings are sampled every 15 minutes and the samples will show if there is movement of the patient's hand. During their typical active period, one should see some constant movement. If the patient's resting period gradually lasts longer than usual, or there is no activity for more than an hour during active period, then the patient may be experiencing a health problem. An alert is sent to the caregiver, and the caregiver may respond to the alert, for example by calling or visiting the patient to determine possible remedial actions.

These historical data point trends, when analyzed over the course of the patient's near-term and long-term treatment, help categorize high risk patients (non-engaged or trending towards) versus other patients (reasonably well engaged), prompting a targeted and timely intervention by the medical staff to the high risk patients, thereby contributing to higher adherence rates.

As an example of an alert to family caregiver, suppose the patient wakes up every day between 7:00 AM and 7:15 AM. Then one day, behavioral data from the PWD does not indicate movement even as of 8:00 AM. This data presents an anomaly in behavior and results in an alert to the caregiver to call and check-in with the patient to if a health issue need to be resolved, or if some other acceptable reason for the anomaly exists.

FIG.9illustrates an example prediction data pipeline of the CCS predictive analytics platform according to the described embodiments. The CCS predictive analytics platform collects data in real-time (reported by the PWD periodically, for example every 15 minutes) from all the PWDs deployed. All these data streams are fed into the EWPA prediction system. The backend consists of a Big Data pipeline processor, predictive analytics engine and a user dashboard with reporting engine to provide results in real time to caregivers and various third party healthcare providers. The backend applications are hosted remotely in the webserver (i.e., in the Cloud).

The Coordinated Care Platform enhances the traditional phase 3 clinical trial process by providing a wearable dedicated for real-time monitoring of the patient and their vitals during the trial. The PWD may also serve as a safety alert device with fall detection and emergency calling features. The PWD also passively collects large quantities (but still high quality) of patient's positional data, vital sign data, and physiological data, in real-time. This technology enables increased volume and speed of data collection, as compared to manual methods in traditional clinical trials, leading to further reduced data acquisition costs. This also helps monitor patients' physical and emotional health in real-time outside of the clinic, and could help reduce expensive site visits by the patient.

The backend Big Data data pipelines can be customized to ingest various types of data streams. The (machine learning) AI-based behavioral analytics algorithms with Early Warning System alerts (on potential non-severe Adverse Events) feed on these (raw and derived) data points, making real-time pharmacovigilance possible and improving associated risk mitigation procedures. The metrics, its associated variability levels and acceptable limits can be customized (or personalized) to every trial. The algorithms and insights from Big Data system can effectively help design better follow-up trials. The PWD and the connected ecosystem make outcomes better, faster, and more meaningful, and reduces data collection costs. As compared to using a diary/notebook, the accurate real-time (and on-time) reporting of status and feedback helps increase the efficacy of clinical trial outcomes and success.

While this invention has been particularly shown and described with references to example embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.