Patent Application
20220139519
Since the 1970s medical research has focused on the problem of patient adherence (also called patient compliance) to prescribed medicine regimens. Lack of patient adherence is a complex problem with many causes that is estimated to generate significant medical costs in both hospital and nursing home admissions. Less than complete patient adherence has been observed to occur in many patients. Lack of adherence can be intentional or unintentional, and includes such things as incorrect dosage, taking doses at the wrong time, forgetting to take one or more doses, and ceasing to take the medication. It is not uncommon, for example, for patients to reduce the dosage in order to limit side effects or to make expensive medication last longer.
Accurate and reliable measurement of patient adherence is a challenging ongoing problem that has no widely accepted solution. Direct traditional measures of adherence involve measurement of body fluid (blood or urine) to detect the concentration of the drug or its metabolite or marker. Direct observation is sometimes used but this is applicable mainly for hospitalized or nursing home patients. Direct methods are considered the most accurate, but they are both invasive and costly. Several indirect measurement methods have been used, although they tend to be less accurate. These include self-reporting methods such as patient interviews and the use of diaries. Periodic pill counts at doctor's offices also have been used. Less cumbersome for the patient is the use of prescription refill dates, but here the adherence results are delayed and less precise. Outcome measures also have been used, but sometimes it can be difficult to directly correlate outcomes with patient adherence.
The use of customized electronic devices to measure patient adherence tends to be more accurate, but it also can be more expensive. In addition to measuring patient adherence these devices also attempt to improve adherence by providing reminders to the patient that it is time to take medication. Prior art includes a number of devices that have been developed that extend and enhance the widely-used basic pill organizer. Most devices are restricted to tablets and capsules that fit within the bins of a pill organizer, pill dispenser or pillbox. There are several different styles of medication that are not easily accommodated by pill tray bins such as inhalers, injections, eye drops, liquid medication that may or may not have to be refrigerated, and medicine in blister packs. Younger patients who are not retired often have to take medicine at work as well as at home. Medication is taken monthly, weekly, daily, and multiple times per day. To accommodate this wide variety of circumstances, a plurality of dose types should be supported where a dose is any collection of medications that can be taken at the same time. To support multiple dose types, multiple dose reminder types and multiple of means of recording doses are required.
Prior art also includes devices that provide a patient web site, typically on a centralized server, that communicates with the pillbox. Patient web sites provide adherence results and they also can be used to remotely configure the pillbox. Given current technology, it is possible to host the patient web site locally in the pillbox itself. This has the advantage that the patient can access it through a local Wi-Fi network even when an Internet connection not present. It is increasingly the case that individuals make use of cell phones for email, and text messaging. Although a patient web site is an effective way to communicate with a pillbox, there is an equally effective alternative approach that uses short email and text commands. Secure commands can be sent directly to the pillbox from a restricted set of users including the patient and a guardian who monitors the progress of the patient in adhering to the medicine regimen. These commands can both request adherence results and configure the pillbox to accommodate the needs and desires of the patient. Email and text commands have the advantage that they can be sent using both a cell phone network and an Internet connection.
With prior art there does not appear to be a widely accepted standard way to report patient adherence results. The smart pill organizer provides real time numerical measures of patient adherence that include dose quantity, dose timing, dose spacing and overall adherence. The measures range from 0% to 100% where 100% represents perfect adherence and 0% corresponds to a complete lack of adherence. For example, if the patient takes only half of the scheduled doses, but the doses that are taken are taken at their scheduled times, then the dose quantity adherence is 50% and the dose timing adherence is 100%.
This simplified summary provides a basic understanding of some aspects of an embodiment of the smart pill organizer, more simply referred to as the pillbox. A more comprehensive overview of the essential features and scope of the pillbox can be found in the detailed description section.
The pillbox is a smart pill organizer designed to facilitate patient adherence by recording and remotely monitoring medicine usage in a home. It is designed for use by two individuals, a patient who takes the medication, and a guardian who oversees the patient's progress in following the prescribed medicine regimen. The guardian might be a family member, health care provider, or service that remotely monitors patient adherence using a digital device such as a PC, lap top, tablet or cell phone.
The embodiment of the pillbox consists of two instrumented weekly pill trays mounted on an enclosure that includes custom electronics designed to issue patient reminders, monitor patient adherence, host a patient web site, and facilitate communication between the patient and the guardian using email and text messaging. An alternative embodiment in a larger enclosure can include four or more pill trays.
The front of the pillbox features three LEDs. The blinking red LEDs provide reminders that it is time for a dose, a dose is late, or the pillbox is empty, while the solid green LED indicates that the pillbox is connected to the Internet. There are also bright white LEDs inside each pill tray bin that blink to show the patient which bin to remove a dose from. Here a dose is any assortment of medications that can be taken at the same time. Pillbox doses are recorded by micro switches inside the bins that detect that a lid has been opened. The back of the pillbox includes two pushbuttons. When the pillbox status button is pushed the pillbox plays a voice message that announces the day, date, time, dose schedule, an adherence summary, and directions for connecting to the patient web site. The recessed password reset button restores the web site usernames and passwords of the patient and guardian to their default values. The back of the pillbox also contains an external memory stick (a USB flash drive) that is used to customize the pillbox for use by the patient. It also includes a wired network connector for wired Internet operation and a power connector. The pillbox is powered with a 5V DC wall transformer (12 W) similar to that used to charge cell phones.
Access to the patient web site is available locally on the patient's Wi-Fi network by entering the pillbox private IP address into a web browser. The guardian can access the patient web site remotely over the Internet using the public IP address of the patient's Wi-Fi network once the patient's router has been configured for port forwarding. A second way to remotely access the patient pillbox is through the use of a comprehensive set of email and text commands that duplicate and extend the functionality available on the patient web site. Using the patient web site or the email and text commands, the patient and the guardian can access patient dosage history and adherence data. They also can configure the pillbox options to customize it to fit the needs and desires of the patient. Email and text commands can be sent to more than one pillbox on the same Wi-Fi network, and an administrator can use an email command to remotely update the pillbox software to a new version. Unlike a patient web site, email and text commands can be sent using both a cell phone network and an Internet connection.
The pillbox supports five types of reminders and three types of doses. Local reminders include light (blinking LEDs), sound (audio beeping), and descriptive voice messages while remote reminders include descriptive email and text messages. When needed, dose reminders are placed on hold until sufficient time has elapsed to satisfy an adjustable minimum dose spacing requirement. The three dose types are pillbox doses, external doses, and remote doses. Pillbox doses are stored in pillbox bins and are taken at home. External doses also are taken at home but they do not fit in a pillbox bins so they are instead stored in their original medicine containers. Examples of external doses include inhalers, eye drops, injections, liquid medication, and pills in blister packs. Remote doses are doses taken at work or away from home and stored in separate medicine containers. While a pillbox dose is recorded when the bin containing the dose is opened, external and remote doses are recorded when the patient replies to an email or text reminder. Remote doses also can be recorded using email and text commands or the patient web site. Doses can be of one type on some days of the week and another type on other days of the week. Medication can be scheduled monthly, weekly, daily, or multiple times per day.
Unlike basic pill organizers, the pillbox provides the user with numerical measures of patient adherence including dose quantity, dose timing, dose spacing, and overall adherence. Adherence measures are computed in real time with patient adherence updated every time a dose is taken. Numerical adherence measures range from 0% to 100% where 100% correspond to perfect adherence. Weekly summaries of patient adherence and monthly dosage history summaries are emailed to the guardian to help monitor the progress of the patient. A patient adherence summary is available at any time using the pillbox status pushbutton.
The pillbox supports a feature called direct voice messaging. The patient and the guardian can schedule brief messages using the patient web site or email and text commands. For example, a message might remind the patient of a doctor's appointment or perhaps include words of encouragement from the guardian. The messages are direct in the sense that with normal pillbox operation the patient is guaranteed to hear the message because it is played on the scheduled delivery date when the patient opens a bin to take a dose.
The role of the guardian is to oversee the physical well being of the patient. In addition to monitoring patient adherence, the guardian also can monitor the state of the patient's environment by remotely measuring the temperature and the states of multiple external switches placed throughout the patient's home. This allows the guardian to detect if the temperature falls below a lower limit due to a problem with a furnace or rises above an upper limit due to a malfunctioning air conditioning system. In this event a remote alert is issued. The temperature limits are adjustable using the patient web site or email and text commands.
The email and text commands and the patient web site allow the user to create and edit a patient medication list that can be taken to doctor's appointments. When the medicine list is created or updated, it automatically generates descriptive dose reminders and a separate form that can be used to refill the pillbox.
Each of the individual parts shown in the figures and drawings has a unique part ID number with the list of part ID numbers summarized in Table 1.
This is a description of an embodiment of the smart pill organizer. For convenience the smart pill organizer is often referred to more simply as the “pillbox”. The pillbox is designed to facilitate patient adherence by recording and remotely monitoring medicine usage in a home. It is further designed for use by a pair of individuals, a patient who takes the medication, and a guardian who oversees the patient's progress in following the prescribed medicine regimen. One example of a patient might be an elderly parent living alone with the guardian being a son or daughter living at another location. More generally, the guardian could be a health care provider or a service. Remote access to the pillbox by the guardian is available using digital devices including PCs, lap tops, tablets and cell phones.
The smart pill organizer has been under development for some time. As experience with using the pillbox accumulates, new user features are added, particularly those that can be accommodated with updates to the underlying software. The embodiment described in this document uses a Raspberry Pi 3B+ processor board and software written in C, PCP, and HTML. Alternative embodiments may employ more advanced processing units and different programming languages. This description starts with a characterization of the hardware. This is followed by a description of user features for both the patient and the guardian. Next the implementation of the patient web site is presented. Finally an overview of the pillbox software is provided.
Pillbox Hardware
Shown in
The electronics of the pillbox are housed in a plain ABS plastic enclosure. This enclosure is modified with custom cutouts to accommodate the user interface to the electronics.
The next cutout on the back of the enclosure is a circular hole 19 for the pillbox status pushbutton. When this button is pushed it plays several voice messages to describe the state of the pillbox. The embodiment plays the day, date and time, the dose schedule, an adherence summary, and instructions for signing on to the patient web site. The second circular cutout 20 is for plugging in a 5V DC power cord. The embodiment uses a 2.4 A wall transformer supply (12 W) similar to that used to charge cell phones. The last circular cutout 21 on the back of the enclosure is for the password reset pushbutton. When this recessed button is pushed, it resets the web site usernames and passwords of the patient and the guardian to their default values. This pushbutton is flush with the back of the pillbox to avoid accidental activation. It can be pushed using a pen or a paper clip.
Power Failures
The pillbox has been designed to respond gracefully in the event of a power failure. The pillbox can be unplugged at any time and then plugged back in. This is a “cold boot” of the system, and normal operation is restored once the power up sequence is complete. During a power outage, all patient dosage history data and patient adherence data are preserved along with the configuration parameters used to customize the pillbox for use by the patient. In the event of a prolonged power failure, there will be no reminders issued while power is out, but the patient can continue to take medicine. When power returns the state of the pillbox bins will have changed. Consequently, any doses taken during the power failure will be recorded when power returns. As an option, a rechargeable 5V battery pack similar to those used with cell phones can be used as a standby power source.
Dose Reminders and Types
Given the flexibility of the hardware design, the pillbox allows for numerous user features to facilitate patient adherence. To begin with, there are two classes of dose reminders provided, local reminders and remote reminders. Local reminders include light (blinking LEDs), sound (beeping), and descriptive voice messages. Local reminders are available for local doses which include pillbox doses and external doses. Recall that external doses are taken at home, but they do not fit in the pillbox bins so they are stored in their original medicine containers. Examples of external doses include items such as inhalers, eye drops, injections, liquid medication, and pills in blister packs. Each type of local reminder can be enabled or disabled. In the case of sound and voice, the spacing and the duration of the reminders can be adjusted.
There are also two types of remote reminders, email and text messages. Like the voice reminders, they are descriptive in the sense that they use information from the medication list and include the dose type, dose location, and the name or number of medications. Remote reminders are used for external doses and remote doses. Recall that a remote dose is a dose taken at work or away from home that is stored in a separate medicine container. Whereas pillbox doses are recorded when a bin is opened, external and remote doses are recorded when the patient replies to an email or text reminder. Remote doses also can be recorded using email and text commands or the patient web site.
Dose Frequencies
There is a dose frequency parameter that controls how often a dose is taken. The dose frequency ranges from 0 to 35. Zero selects a daily dose while 1 to 7 select a weekly dose where 1 selects Sunday, 2 selects Monday, and so on through 7 which selects a Saturday dose. Monthly doses are also possible using selections 8 to 35 where 8 selects day 1, 9 selects day 2, and so on through 35 which selects a dose on day 28. Note that since the same medicine can occur in more than one dose, this allows for doses whose medicine can be taken monthly, weekly, daily, or multiple times per day.
Remote Doses
When a patient is going to be away from home, there are a number of ways the pillbox can continue to be used. If the patient will only be gone part of a day, they can take their medicine with them and record the dose remotely using either email and text commands or the patient web site. When the patient will be away longer, they can take the pillbox with them. In this case, data lines one and two of the external memory file wifi.txt should be updated to reflect the Wi-Fi network at their new location. Still another possibility is to leave the pillbox home, but put it into something called the mode. This is done by using email and text commands or the patient web site to enter the start date and time and the end date and time of the vacation. When the start date and time arrives, all doses are automatically reclassified as remote doses, and when the end date and time arrives the process is reversed and the doses are restored to their original types. One advantage of the vacation mode is that local reminders are suppressed so individuals remaining at home are not bothered by light, sound, and voice reminders.
For remote doses there is a parameter called remote days that indicates which days of the week the dose is remote, otherwise the dose is external. Thus doses can be of one type on some days of the week and another type on other days of the week. For example, a remote days parameter of 0,1,1,1,1,1,0 indicates that the week days M-F are work days with remote doses, while the weekends are external doses taken at home.
Numerical Adherence Measures
A novel characteristic of the pillbox is that it provides simple numerical measures of patient adherence. Adherence measures are updated in real time every time a dose is taken. Each numerical measure ranges from 0% to 100% where 100% represents perfect adherence and 0% represents a complete lack of adherence. Arguably the most important adherence measure is dose quantity adherence. It measures the degree to which the patient takes the correct number of doses. For dose i let missed be the number of missed doses, extra be the number of extra doses, and days be the number of days in operation. Then the dose quantity adherence Aq for dose i is defined:
Aq=100*max{1−(missed+extra)/days,0}%
Note that as the quantity (missed+extra) goes from 0 to days, Aq decreases linearly from 100% to 0%. Thus if all the doses are taken, Aq=100%, if half are taken Aq=50%, and if none are take Aq=0%. The max or maximum function is included to make sure that Aq does not go negative if there are several extra doses taken.
Often it is important that doses be taken at the correct time. For example, some doses should be taken at meal time with food. Let Ti be the measured time for dose i, T be the scheduled time, and Tw be the radius of a user-selectable time window. Then the dose timing adherence At for dose i is defined:
At=100*max{1−mean(|Ti−T|)/Tw,0}%
Similar to dose quantity adherence, as the mean or average of |Ti−T] goes from 0 to Tw, At decreases linearly from 100% to 0%. For example, if mean(|Ti−T|)=Tw/2, then At=50%. Note that as the radius of the user-selectable time window, Tw, decreases the dose timing adherence becomes more sensitive to early and late doses.
Not only can dose timing be important, so can dose spacing. For example there can be some medications that interfere with other medicines so the spacing of doses must be carefully controlled. Let Si be the measured spacing between dose i and the previous dose, and let S be the scheduled spacing. Then the dose spacing adherence As for dose i is defined:
As=100*max{1−mean(|Si−S|)/S,0}%
Again as the mean or average of |Si−S| goes from 0 to S, As decreases linearly from 100% to 0%. If mean(|Si−S])=S/2, then As=50%. As a convenience to the user, a fourth numerical measure of patient adherence called overall adherence is computed. Overall adherence A is a weighted sum of dose quantity, dose timing, and dose spacing adherence defined as:
A=wq*Aq+wt*At+ws*As%
The adjustable weight coefficients are fractions between 0 and 1 that sum to unity, wq+wt+ws=1. Like the other measures of adherence, the overall adherence then ranges from 0% to 100%. Overall adherence is provided simply as a convenience to the user because it is not obvious what the weighting coefficients should be. However, it is clear that dose quantity adherence is the most important because if a dose is not taken then for that dose the dose timing and dose spacing are not defined. The default relative weights are wq=0.6, wt=0.2, and ws=0.2.
Minimum Dose Spacing
Another important aspect of dose spacing is governed by an adjustable parameter called minimum dose spacing. Over the counter pain medications often include instructions like take no more than two tablets per length of time. The embodiment of the pillbox is not a physically secure pill dispenser (with lockable lids) so it cannot guarantee minimum dose spacing by prohibiting patient access to the medication. However, it can guarantee that dose reminders follow a minimum dose spacing requirement. More specifically, suppose two doses are overdue. Once the first dose is taken email, text and voice messages are issued saying that reminders for the other dose are on hold until the minimum time between doses has elapsed. Whenever a new dose scheduled is submitted, the schedule will be rejected if it violates the minimum dose spacing requirement.
Direct Voice Messaging
Another feature of the pillbox is the implementation of something called direct voice messaging. Both the patient and the guardian have the ability to use the patient web site or email and text commands to schedule one or more brief messages. These voice messages are intended for the patient and they are played on their scheduled delivery dates when the patient opens a bin to take a pillbox dose. Examples of direct voice messages might include things like reminders of doctor's appointments, or even words of encouragement from the guardian. The messages are direct in the sense that with normal pillbox operation the patient is guaranteed to hear the message because it is played on the scheduled delivery date when the patient opens a bin to take a dose. This is in contrast, for example, to an answering machine where the patient must actively seek out the message and play it back in order to hear it.
Patient Environment
There is a feature of the pillbox that does not directly affect patient adherence. However, it does allow the guardian to monitor the well being of the patient. If the temperature of the patient's environment falls below a lower threshold or rises above an upper threshold, the guardian will receive email and text messages indicating that the patient's furnace or air conditioning are not operating properly. By using email and text commands or the patient web site the current temperature can be obtained and the lower and upper temperature limits can be adjusted.
The embodiment of the pillbox shown in
Remote Access
An important aspect of the operation of the pillbox is the ability to access the patient pillbox remotely from any location with a cell phone network or an Internet connection. Using remote access the patient can receive remote reminders and record remote doses. Equally important is the access provided to the guardian. With remote access, the guardian can easily monitor how well the patient is doing in adhering to the prescribed medicine regimen. Dosage history, adherence summaries, and patient data can be viewed on the patient web site, emailed to the guardian, and printed in hard copy form if desired. The guardian also can remotely reconfigure the operation of the pillbox at any time to better customize it so it matches the needs and desires of the patient.
There are two types of remote access supported. One is the through the patient web site and the other is with email and text commands. Access to the patient web site is both local on the patient's Wi-Fi network and remote over the Internet. For local access the patient must enter the private IP address of the pillbox in the address bar in the upper left corner of a web browser. The private IP address can be obtained by simply pressing the pillbox status pushbutton on the back of the pillbox. The private IP address is a static address that depends on the patient router, and is typically of the form 192.168.xxx.yyy. Here the third field xxx is between 0 and 255 and is the number of the subnetwork used by the router. The last field yyy is a user-selectable parameter called the pillbox id, an integer between 2 and 253. By using distinct pillbox ids, more than one pillbox can be accessed on the same local Wi-Fi network. The pillbox id parameter is listed in external memory file wifi.txt. It should be chosen to lie outside the range of IP addresses dynamically assigned by the patient router.
Remote access to the patient web site over the Internet is generally similar to local access, but with two important differences. First the patient router must be configured to use port forwarding. More specifically, port 80 which is the port used by web browsers must be forwarded to the private IP address of the pillbox. The details on how this is done depend on the make and model of the router. Port forwarding is normally set up when the pillbox is installed. A patient or guardian who is sufficiently familiar with computer hardware can set up port forwarding using the pillbox guide documentation on the patient web site. Once the router is configured for port forwarding, the only other thing that is needed is the public IP address of the patient's Wi-Fi network. This can be found by clicking on the Find icon on the patient web site. Alternatively, one can use a web browser on the patient Wi-Fi network and enter the search string whatismyip. The guardian then can access the login page of the patient web site by using the public IP address. In summary, remote access to the patient web site is just like local access but with the private IP address replaced by the public IP address.
Email and Text Commands
The second way to remotely access the pillbox is through a comprehensive set of email and text commands. This approach has a number of advantages. First, it does not require that the patient's router be configured for port forwarding. Second, it allows for remote access to more than one pillbox on the same local Wi-Fi network. Third, email and text commands can be sent using both a cell phone network and an Internet connection. For email and text commands to securely access a pillbox a number of requirements must be met. The command must be sent to the unique gmail address of the pillbox. In addition, the command must come from a limited set us users namely the patient, the guardian, or an administrator. Next, the email or text message must include the string <*serial_number*> where serial_number is the pillbox serial number typically listed on a sticker on the bottom of the pillbox. The serial number is a unique string of eight alpha-numeric characters. The final requirement is that the email or text message must contain one or more commands that follow the format [name: value] where name is the name of the command and value is the command value, an integer or a string. The embodiment of the pillbox includes 51 integer commands and 23 string commands that duplicate and extend the functionality of the patient web site. There are also a number of hidden administrator commands that are used for customer support and software maintenance. For example, there is an email command that allows the administrator to remotely update the pillbox software to a new version.
Patient Web Site
The patient web site provides a simple way to monitor how well the patient is adhering to the prescribed medicine regimen. It also provides a convenient way to configure the pillbox so it is optimized for use by the patient. The patient web site can be accessed locally on the patient's Wi-Fi network using the private IP address of the pillbox. Once the patient router has been configured to use port forwarding, the patient web site also can be accessed remotely over the Internet using the public IP address of the patient's Wi-Fi network. This document describes an embodiment of the patient web site. As experience with the pillbox accumulates, new features are added to the patient web site and existing features are improved in subsequent versions of the pillbox software.
Secure access to the patient web site starts with a login page that requires the user to supply a valid username and password. There are three levels of users, patient, guardian, and administrator. For the administrator the programming page also includes additional items such as pillbox diagnostics and software maintenance operations. These items are discussed in detail in the pillbox guide. The patient web site contains three pages in addition to the login page: dosage history, adherence summary, and programming.
Dosage History Page
A list of the items appearing on the dosage history page is shown in Table 2. The dosage history page starts with a set of links to the other pages and a link to the pillbox guide. The pillbox guide is a pdf document that describes the design and operation of the pillbox in some detail. The link section also includes date and time information, the pillbox private IP address, and the installed version of the pillbox software. Below the links section is a table of contents for the dosage history page with local links to the different items on the page
The first item in the contents is user controls. User controls allow the user to clear the patient data, restore the default parameters, restore the file wifi.txt, record a remote dose, select a week for the dosage history display, or find the public IP address of the patient's Wi-Fi network. All of the action labels on the left side of the user controls table are links to help tips that describe the item in more detail. This form of context-sensitive help is used throughout the patient web site. In order to activate a newly entered value for a user control item, the user must click on submit changes. Depending on the item selected, it may take some time before the action can be completed and reflected in a refreshed display of the page.
The next section of the dosage history page is a cumulative patient adherence table. It starts with how many days the pillbox has been in operation. There are separate lines for each dose. Each line starts with the dose number, scheduled dose time, dose frequency, dose type, and number pills in the dose. It then displays the measured adherence including dose quantity, dose timing, dose spacing, and overall adherence. The last row lists the averages of the adherence measures for the daily doses. Consequently, in the lower right corner there is a single numerical score measuring how well the patient is doing overall.
Below the cumulative patient adherence table is a dosage history display. By default, the most recent week of data is shown but earlier weeks can be selected using the user controls. The dosage history displays each day on a separate line labeled with the day and date. It then displays 24 hour slots where parentheses are used to show the scheduled times of pillbox doses and square brackets for external and remote doses. The dose number is plotted in the hour slot when the dose is taken. The total score at the end of the row indicates the percentage of scheduled doses that have been taken.
Next there is a small table that is two rows by seven columns. The rows are labeled with the bin or pill tray number and the columns are labeled with the days of the week. The bin status table is a real-time display showing which pill tray bins are open and which are closed.
Below the bin status table is a larger pillbox status table that includes several rows and four columns. The shaded yellow columns contain labels of the parameters whose values are listed in the white columns. The labels are links to help tips that describe the item in more detail. Most of the items in the pillbox status table are parameters whose values can be changed on the programming page.
The next table lists data files that can be emailed to the patient or the guardian. Some of the data files contain patient dosage history and adherence data while others are used to configure the pillbox for use by the patient. The email commands file is a listing of all email and text commands and their current values.
Below the data files table is a mechanism for scheduling direct voice messages to the patient. The currently scheduled voice messages are listed in a table along with their delivery dates. To insert a new message the user simply types it in and then enters a desired delivery date. Scheduled messages can be edited using delete, insert, and replace operations. Messages are sorted based on their delivery dates.
The last item on the dosage history page provides a means to change usernames and passwords. When the patient logs in to the web site, the patient username and password are shown and can be changed. Similarly, if the guardian is logs in, the guardian username and password can be updated. Recall that if the patient or the guardian forget or misplace their username or password, the recessed password reset pushbutton on the back of the pillbox can be used to restore the usernames and passwords to their default values. When this is done, the patient and guardian are sent emails informing them of the change.
Adherence Summary Page
A list of the items appearing on the adherence summary page is shown in Table 3. Like the dosage history page, the adherence summary page starts out with links to other pages followed by a table of contents with local links to the items on the page.
The current medication list is shown with each row corresponding to one entry in the list. When new medicine is inserted, the user must supply the medicine name and dosage, the number of pills per dose, and the dose number each separated by blank space. The next item in the contents is a mechanism for editing the list of medicines using insert, delete, and replace operations. This provides an easy way for a user to create and edit the external memory file medication_list.txt that is read during the pillbox startup sequence. Once a medication list is created or edited, the pillbox software automatically creates descriptive dose reminders and a pillbox refill form. This form, which can be displayed and printed, is helpful when it comes time to refill the pillbox bins. In addition the pillbox refill form serves as a medication list that the patient can bring to a doctor's appointment.
Following the medication list are four adherence summary tables for dose quantity, dose timing, dose spacing, and overall adherence. There are separate lines in the tables for each dose. Each line starts by listing the dose number, scheduled dose time, dose frequency, dose type, the ideal value of the measured quantity, and the number of pills in the dose. The dose quantity table then lists the average adherence, average variation from the ideal adherence, missed doses, extra doses, and cumulative adherence over the number of days in operation. The dose timing adherence table lists the average dose time, average variation from the scheduled time, and cumulative dose timing adherence. Similarly, the dose spacing table lists the average dose spacing, average variation from the scheduled spacing, and cumulative dose spacing adherence.
Next there is a large dose distribution table. This table shows when each dose was taken over the period of time the pillbox has been in operation or since the last time the patient data was cleared. As with the dosage history display, parentheses are used to show the scheduled times of pillbox doses, and square brackets are used to show external and remote doses. By carefully examining the dose distribution histogram table one can tell if the patient tends to take certain doses early or late and by how much.
The last table on the adherence summary page is a display data files table. Seven data files can be displayed and printed if desired. They include files containing dosage history and adherence data, configuration data, and email and text commands.
Programming Page
A list of the items appearing on the programming page is shown in Table 4. Whereas the previous two pages focus on presenting dosage history and adherence data, the programming page is designed to help the user configure the pillbox to fit the needs and desires of the patient. This page starts like the other pages with a links section and a local table of contents section.
The first item in the contents allows the user to configure the dose schedule. This includes strings that specify the dose times, dose types, dose frequencies, remote days, and adherence weights. The user also can select the minimum dose spacing, and the size of the time window. For more than one dose per day items within strings are separated by commas with no blank space.
Next there is a temperature settings table where the user can select both a low temperature limit and a high temperature limit. The safe zone for the patient environment lies between these limits. There is a third parameter called the temperature offset. This is used to calibrate the temperature sensor so it produces an accurate reading at room temperature. For proper calibration, one must wait until the pillbox has warmed up because there can be self heating effects from the pillbox electronics.
Following the temperature settings are vacation mode settings. Here the user enters strings that specify the start date and time and the end date and time of a vacation. To disable the vacation mode one simply sets the start and end dates to be earlier than the current date. Otherwise, once the current date and time reaches the start date and time, the pillbox will automatically enter the vacation mode (all doses remote), and will remain there until the end date and time is reached.
Next there is a general group of settings called operating mode settings. They start with light and sound reminders that can be enabled or disabled. The duration and spacing of the sound and voice reminders also can be adjusted. Voice type can be selected and the voice volume (for festival voice) can be adjusted. Periodic pillbox power resets can be scheduled and the rate at which email and text commands are polled can be adjusted.
The operating mode settings are followed by remote operation settings where there is one column for the patient and another for the guardian. The settings include emailing and texting pillbox alerts, dose reminders, and doses taken. In addition, weekly adherence summaries and monthly dosage histories can be emailed.
In order for remote communications to be activated, patient and guardian contact information must be supplied using the contact information settings. The information required for each individual includes first and last names, email address, cell phone number, and cell carrier.
The next table is the pillbox gmail account settings. Each pillbox should have its own gmail account separate and distinct from the patient and guardian email accounts. The settings include the gmail address and the gmail password. The gmail address is the address that is used when email and text commands are sent to the pillbox.
The last table on the programming page is the real time clock settings table. It starts with a control that selects the time zone. Next it includes a control to enable or disable the use of system time. Normally system time is left enabled. System time is synchronized by periodically contacting a national NTP time server to maintain a real time clock. When system time is disabled, control is transferred to a hardware real time clock with battery backup. This mode is used when the pillbox is operated in a stand-alone mode that does not use an Internet connection. There is also a control to set the date and the time of the hardware real time clock.
When an administrator logs in to the patient web site, there are additional programming page controls for customer support operations including pillbox diagnostics and software maintenance.
Pillbox Software
The embodiment of the pillbox uses a Raspberry Pi 3B+ processor board that runs the Linux operating system. The software resides on a 16 GB micro SD and is written in C, PCP and HTML. Linux makes liberal use of files that enable the different parts of the software to communicate with one another. The pillbox software uses the folders listed in Table 5.
The Hma Folder
The main program folder named hma, short for Home Meds Adherence, contains the main program hma_main.c. Following an initialization section, the main program goes into a loop that runs at about 600 Hz where a number of items are polled including bin status, pushbutton status, web site parameter status, and email and text command status. The main program file includes support functions: get_version, check_minute, check_day, dose_active, and update_globals. Function get_version finds various version numbers during initialization, check_minute and check_day are called once a minute and once a day, respectively, to perform various tasks as needed, and dose_active determines which dose, if any, currently has reminders active or on hold. Function update_globals is called when communications are received in the form of email and text commands or changes to web site parameters.
The hma folder also contains three files called global_constants, global_parms, and global_vars that define constants, parameters, and variables used throughout the program. Global parameters are variables whose values remain constant unless they are explicitly changed using the external memory file wifi.txt, the patient web site, or email and text commands. Global variables are patient data variables whose values change with time as a result of routine patient activity. Global parameters and variables must be kept up to date at all times in the event of a loss of power. This is achieved by saving the parameters and variables in hma folder files hma_parm.dat and hma_var.dat, respectively, whenever a parameter or variable changes.
The Lib Folder
The library folder lib is a large folder that contains most of the C functions used in the pillbox software. The lib folder includes several library files and each of these files consists of a number of related functions that are grouped to achieve a particular type of task. The library files that make of up the lib folder are listed in Table 6.
There are too many individual functions in the lib folder to itemize and discuss here. However, the lib folder does include header files with the .h extension for each of the library files listed in Table 6. These header files list function prototypes for all of the functions in the library file. The functions themselves start with comment lines that describe the function purpose, calling sequence, and calling arguments. For convenience there is an overall header file named hma_header.h in the hma folder that lists the prototypes of all of the C functions in the pillbox software.
Support Folders
There are several general support folders in Table 5. The test folder contains programs and functions for testing various aspects of the pillbox hardware and software. The principle test program is hma_test.c.
The bak and bak_lib folders contain programs and functions used for software development including backup, restore, and install operations. The program hma_backup.c can be used to save the current version of the pillbox software to an external memory zip file or restore a previous version from an external memory zip file. There is also a program called hma_install.c that installs or updates linux packages used by the pillbox software such as the apache web server and getmail.
The next three folders in Table 5 contain temporary files and back up files. The dat folder includes configuration files and data files that are created during normal operation of the pillbox. The profiles folder contains backup copies of the patient configuration files in external memory. Finally the mail file collects email messages sent to the pillbox gmail address.
There are three usb folders that are used. They are named usb folders because the embodiment of the pillbox uses a USB flash drive for the external memory stick. Folder usb contains the plain text configuration files wifi.txt and medication_list.text used to customize the pillbox for use by the patient. The zipped folder contains previously saved versions of the pillbox software, and the history folder contains the patient monthly dosage histories that have been accumulated to date.
The Html Folder
The last two folders in Table 5 are associated with the patient web site and contain files and functions written in PCP and HTML. Folder html contains files index.php for the login page, hma_dosage.php for the dosage history page, hma_adherence.php for the adherence summary page, and hma_prog.php for the programming page. The tips folder contains help tip files for the labels that appear throughout the patient web site.
There are two distinct parts of the pillbox software, the part written in C and the part written in PHP and HTML. These parts must communicate with one another to make the pillbox software fully operational. The lib folder function write_c2php.c starts by writing a dat folder file named c2php.dat that contains parameters and variables destined for the html folder. A companion html folder function named readc2php.php reads the contents of that data file. Whenever a web site parameter is changed by the user, html folder function write_php2c.php writes a second dat folder file named php2c.dat that contains the updated parameters. Main program hma_main.c detects the presence of this file during polling and reads its contents using the companion lib folder function read_php2c.c. Next the hma folder function update_globals is called by hma_main.c to process and save the new web site parameters. In this way the two parts of the pillbox software, written in different programming languages, communicate with one another through a pair of data files.
The smart pill organizer is a flexible device that facilitates patient adherence by remotely monitoring medicine usage in a home. It does so by supporting a variety of dose types including pillbox doses taken a home and stored in the pillbox bins, external doses also taken at home but stored in their original medicine containers, and remote doses taken at work or away from home and stored in separate medicine containers. A plurality of bidirectional communication paths are provided between the pillbox and a guardian who oversees the progress of the patient in adhering to a prescribed medicine regimen. Both the guardian and the patient can request patent data from the pillbox, and send commands to the pillbox to configure it to meet needs and desires of the patient. One avenue of communication is a locally hosted patient web site that is available both locally on the patient's Wi-Fi network and remotely over the Internet. Access to the pillbox is also available more directly through the use of a comprehensive set of email and text commands. This communication channel has the advantage that it can be activated through a cell phone network or an Internet connection. The pillbox provides direct numerical measures of patient adherence ranging from 0% to 100% that include dose quantity, dose timing, dose spacing, and overall adherence. For example, if only half of the doses are taken, but the ones that are taken are taken on time, then the dose quantity adherence is 50%, and the dose timing adherence is 100%.
The detailed description section discussed the first embodiment of the smart pillbox. Several alternative embodiments are possible. The embodiment shown in
The first embodiment described the use of a Wi-Fi network to access the patient web site. It is also possible to use a wired network connection. Indeed, the back of the pillbox already has a wired network connector, and if it is used the pillbox automatically selects the wired network when it is powered up. Another possible embodiment uses no Internet service at all. This is possible because the pillbox already includes a real time clock with battery backup. Using a router, the patient still can access the web site locally to examine patient data and configure the pillbox. If no router is present, another way to configure the pillbox is through the use of the external memory stick. The first embodiment uses a USB flash drive for the external memory stick, but alternative embodiments can use any type of portable external memory device that is capable of storing files.
The first embodiment uses mechanical micro switches 24 as shown in
The first embodiment includes a external switch connector 38 in
The alternative embodiments summarized above should not be construed as an exhaustive list that limits the scope of embodiments; instead they provide illustrations of several of the embodiments that are possible.
