WO2012050882A1 - Medication compliance device - Google Patents

Abstract

A device uses behavioral conditioning based on social response to increase medication adherence. It motivate adherence by displaying pictures of socially connected people, animals and/or other characters, displaying emotional reactions contingent on pill- taking activity. As a result, the consequences of non-adherence are immediate, concrete and target motivational neural circuits.

Description

MEDICATION COMPLIANCE DEVICE

Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 61/387,167, filed Sept. 28, 2010 and U.S. Provisional Application No. 61/488,412, filed May 20, 2011, the entire contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] The Cost of Medication Noncompliance

[0003] Many patients with chronic illnesses such as high blood pressure and elevated cholesterol don't take medication as prescribed. As a result, a seemingly healthy person can experience a sudden stroke or a heart attack after stopping an important drug. About 50 percent of patients with chronic illnesses are non-adherent to prescribed medication.

[0004] Non-adherence with prescription medications has been labeled an "epidemic" (Sherman, 2007), and a "worldwide problem of striking magnitude" (World Health

Organization, 2003). For providers, non-adherence yields frustration in clinical management and can result in economic loss for those reimbursed under pay-for-performance. Non- adherence increases healthcare costs for payers and employers and contributes to inferior beneficiary outcomes. For pharmaceutical companies who discover and manufacture prescription medications and for pharmacies who sell them, non-adherence results in significant revenue loss (McHorney, 2009). Non-adherence is estimated to cost the average pharmaceutical brand 38 percent of its sales, and $30 billion in lost revenue for the pharmaceutical industry as a whole. An additional $8 billion annual revenue is lost by pharmacies as a result of unfilled prescriptions (Cutting Edge Information, 2006). The overall cost to the United States economy for patient non-adherence is estimated at $100 billion annually (Chodon Group). [0005] The Psychology of Irrational Decision Making

[0006] Most people intend to take prescribed medications, and start out with a high level of adherence. Over time, however, non-adherence tends to fall off as the pill-taking task becomes tedious and results in no subjectively-discemable effects on heath. Additionally, the medication loses emotional valence as the medical event that triggered the prescription (such as chest pain, or simply the discovery of the diagnosis) fades into the past.

[0007] In general, it is difficult for individuals to consistently act in a rational fashion to pursue their long-term interests. This problem is particularly evident in the domain of health- related behaviors. People may intend to eat a healthy diet, exercise regularly, undergo preventive medical procedures, and take medications as prescribed, however they fail to regulate their behavior in accordance with long-term goals. Motivating more rational choices requires an understanding of the neuropsychological basis of behavior. A number of findings are particularly relevant to this device.

[0008] Concrete consequences of decisions have greater influence over choice than more abstract ones. For example, a person is less likely to purchase a $100 cell phone if he has to remove actual money from his wallet compared to using a credit card (Feinberg, 1986).

[0009] People are more likely to align their behavior in accordance with long term goals if there are immediate negative consequences for failure (punishment), compared to positive consequences for compliance (reward). This imbalance is related to psychological loss aversion. Most people refuse an offer to flip a coin to win $110 for heads and lose $100 for tails even though the net value of the offer is positive (Thaler et al., 1997). The knowledge that our behavior has harmed another person stimulates feelings of guilt. From the perspective of operant conditioning, guilt acts as a punishment. Punishments have greater effects on behavior than rewards (more specifically, avoiding a negative outcome is more rewarding than experiencing a positive one). In general, guilt is one of the most powerful stimuli in terms of influencing behavior.

[0010] The feeling of guilt that occurs as a result of harming another person is more aversive, and therefore more motivating, than the knowledge that one is harming oneself. For example, substance abusing women often give up drugs after becoming pregnant, because they are at risk of harming the fetus, instead of only themselves (Ockene et al., 2002). An increased rate of substance use cessation is seen even in women who place their children for adoption (Massey S., et al., unpublished data). When the victim is vulnerable and in a dependent relationship with the decision-maker, the motivation is strongest.

[0011] Activating social circuits in the brain, by creating a risk of eliciting negative emotional reactions in others, is an effective way of increasing adherence to even the most difficult health-related behaviors. This insight forms the basis of Alcoholics Anonymous, where social pressure is used to help members maintain sobriety. Similarly, people who tell family and friends that they intend to quit smoking are more successful than those who do not (Mermelstein et al., 1986).

[0012] Pairing a neutral stimulus (e.g., medication non-adherence) with a distress-evoking aversive stimulus (e.g. guilt associated with a social relationship) is a form of classical conditioning. Eventually, the non-adherence alone evokes distress.

[0013] Exploiting the psychology of decision making is commonly used to influence consumer behavior. One expert in the field states, "We know that what triggers buying decisions is emotion. We make emotional decisions, and then we rationalize them" (Renvoise and Morin, 2007). The same is true of health-related decisions. An intellectual understanding of the consequences of stopping a medication is not enough to ensure compliance. Educating people about medication is not an effective way of increasing adherence. In order to change behavior, emotions must be targeted. [0014] The Neurobiology of Social Attachment

[0015] During the past decade the field of social neuroscience has emerged as molecular methods and neuroimaging tools have been used to investigate social behavior. It has been found that targeting pathways in the brain responsible for social interaction can profoundly affect behavior because the neural circuits responsible for social behavior are so closely linked to the dopaminergic mesolimbic reward centers of the brain. This finding has led Insel to speculate that "social attachment is an addictive disorder" (Insel, 2003).

[0016] Studies of human attachment show marked overlap between the pattern of activation when looking at or hearing a loved one, and activation during cocaine-induced euphoria (Bartels and Zeki, 2004; Breiter et al., 1997; Lorberbaum et al., 1999). It seems likely that pathways that mediate the hedonic properties of psychostimulants evolved as neural systems for social attachment (Insel and Young, 2001). Although psychostimulant use can compete successfully with social behaviors, in one animal model of maternal infant bonding, postpartum female rats were found to prefer a cage associated with pups compared to a cage associated with cocaine (Mattson et al., 2001).

[0017] Clinical studies have found that like muscle power, will power is subject to exhaustion. Accordingly, the use of will power to bring about long term behavior change can be expected to have a high failure rate. Will power works most effectively over short periods of time. Consequently, cognitive/educational approaches to enhancing adherence to medications used to treat long-term illnesses are largely ineffective compared to strategies that engage emotional processes. SUMMARY OF THE INVENTION

[0018] A device is provided which uses behavioral conditioning based on social response to increase medication adherence. It motivates adherence by displaying photographs of socially connected people, animals and/or other characters, displaying emotional reactions contingent on pill-taking activity. As a result, the consequences of non-adherence are immediate, concrete, and target motivational neural circuits.

BRIEF DESCRIPTION OF THE FIGURES

[0019] FIG. 1 shows a medication adherence device in the charitable mode in accordance with the preferred embodiment of the invention.

[0020] FIGS. 2 show series of pictures used in the personal mode in accordance with an alternative embodiment of the invention.

[0021] FIG. 3 is an operational block diagram of the device function.

[0022] FIG. 4 shows another embodiment of the invention.

[0023] FIG. 5 shows an illustrative control panel display in accordance with the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] In describing a preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents that operate in similar manner to accomplish a similar purpose.

[0025] Turning to the drawing, FIG. 1 shows the adherence device system 5 in accordance with a preferred embodiment of the invention. The device generally comprises a dispenser 10, a display 30, and a control panel 40 housing a processor 42. The dispenser 10 stores the medication, such as pills 20. As shown, the dispenser 10 can have a separate container compartment 14 for different drugs to be taken by the user. When it is time for a drug to be taken, a light is illuminated on the appropriate compartment. The compartments 14 can also be used for each day of the week to store the pill(s) 20 needed for that particular day. Each compartment 14 can have a separate cover 12, which is opened to store and retrieve the medicine 20. A switch 16 is triggered when the cover 12 of the compartment 14 is opened. A separate switch 16 can be provided for each container 14, or a single switch 16 can be provided for all of the container compartments 14. In addition, the device 5 can optionally have a wired or wireless network connection, such as Ethernet, Bluetooth, wifi, or cellular, so that new media can be loaded and to communicate adherence data to an online account or to a third party (e.g. , directly or via a website) such as a healthcare professional.

[0026] The control panel 40 has an input device 44, such as a keyboard and/or touch screen controls, to receive information such as the schedule for the medicine to be taken. The control panel 40 also has a slot 46 to receive the memory card with pictures, and can also have a storage device such as an internal or external memory 48, RAM or ROM. The processor 42 is in communication with the display device 30 and the dispenser switch 16. The processor 42 has a memory or a memory card reader 46 to store and/or load photographs. The processor 42 also has a keypad that is used to control of the device, and a processing chip. The control panel 40 can also be provided with buttons to switch the system 5 between the various modes of operation, if necessary.

[0027] In response to the operation of the switches 16, the processor 42 determines whether or not the user is adhering to the medicine prescription. For instance, the processor 42 can be programmed to expect that the switch 16 will operate one or more times a day or week, at certain times. If the cover 12 is not opened at the appropriate time, the processor will determine that the user is not in compliance with the prescription. In response, a light is illuminated at the appropriate compartment 14. In addition, when the user is out of compliance, photographs of individuals are shown who display emotional evidence of harm when non- adherence occurs serve as the motivating factor.

[0028] Referring to FIG. 3, a flow / block diagram is shown. The adherence device 5 can include an oscillator 102 and counter 104 for determining the elapsed time which

communicate with and is controlled by the processor 42, or the entire operation can be implemented by the processor 42. At step 106, the processor 42 detects from the switch 16 that the container compartment 14 has been opened. At step 110, the elapsed time from the counter 104 is compared with the desired interval 108, and the elapsed time counter is reset. The desired interval 108 is stored in memory 48, and compared with the elapsed time from the counter 104. The picture state 116 is controlled by the processor 42 in response to a dose being taken or being missed.

[0029] If the dose is missed, the processor 42 can also activate a red light 112. For instance, this can be achieved by comparing at 110 the elapsed time from the counter 104 to the desired time 108. If the elapsed time exceeds the desired time, and the compartment 14 has not been opened, the red light 112 can be activated. In addition, the system 5 can operate based on a specific time or times that medicine should be taken, rather than using elapsed times. Thus, for instance, the processor 42 can store the time(s) of day (e.g. , 9am, 2pm, 6pm) in the memory 48, and can activate the red light 112 when those times are passed. Or, can activate a green light 112 by the appropriate compartment 14 (and/or display an image at the display 30) within an acceptable time to take the medicine (e.g. , from 8am-9:30am, l-2:30pm and 5-6:30pm, respectively), then generate a red light 112 at the appropriate compartment 14 (and/or display an image at the display 30) after that period has expired. [0030] In yet another embodiment of the invention, the device 5 can be provided with a proximity sensor 114. The proximity sensor 114 can determine when an individual is located within viewing range of the display 30. When an individual is located nearby, the processor 42 can control the device to display a specific response, particularly when the user is out of compliance.

[0031] The present invention can function in any of three modes: personal, charitable support, and model. In the personal mode, photographs of an important social contact are displayed on the display device 30. As shown in FIG. 2(a), multiple photographs 32 of a loved one, such as a child, grandchild, significant other, or friend, are loaded onto the memory 48 of the device. The pictures can show the individual in various emotional stages, from a happy state to a state of emotional pain. Or, two (or one) pictures can be stored, one showing a happy state and one of emotional pain, and the processor 42 can implement a digital morphing algorithm to generate a series of intermediate pictures that depict the reacting individual in states of increasing distress. The pictures and the prescription times can be entered by the user or by a loved one of the user.

[0032] When medication is taken as prescribed, the picture of the loved one in the happy state is displayed. When one or more doses are missed, the picture gradually evolves into a more and more distressed state. If adherence is re-established, the process reverses. This mode exerts the greatest degree of social pressure because the reacting individual has a preexisting, important relationship with the patient.

[0033] In the charity mode, the reacting individual can be a disadvantaged child who represents a charity that receives direct financial benefit in proportion to the patient's medication adherence. A charity fund can be established by charging the user when the device is purchased, charging the user a monthly fee, or by gifts received from organizations. For each day of medication adherence, a portion of the money from the fund is committed to the charity. In addition, on days of non-adherence, a portion of the money can be lost. The full adherence picture shows the child in a happy state, emphasizing the effects of charitable support (FIG. 1). When non-adherence occurs, the picture changes to one in which the child demonstrates emotional distress. A red light goes on indicating that the money that would have gone to the charity on that day has been lost. Users are able to select from a list of charities in such so that the charity that is used has the highest emotional relevance.

Available charities can include animal rescue, biomedical research, disaster aid, and aid to the hungry in different geographical locations.

[0034] Periodically, the money "earned" is transferred to the charity. The specific amount is communicated by having the patient dial a toll-free number and then entering a code, which can be displayed on the screen. Messages recorded by children thanking the user are used to consolidate the emotional connection to the adherence device. Periodically, a new child is used as the reacting individual in order to maintain novelty. After one year, a new donation is requested, and a new SD memory card is sent with new photographs, or the processor can retrieve the pictures by telephone or over a network connection.

[0035] This mode is less complex than the personal mode because the pictures are preloaded onto the device before it is purchased. High quality photos can be obtained, and pre-made sophisticated morph sequences can be included without the need for the device to perform complex processing. As a result, a simpler, less expensive processing chip can be used to control the device. The system can also show "Reward" videos - for example a video of well-dressed school children, or happy children using a new water well - at the end of the month if a pre-set level of adherence was achieved. A variable reinforcement schedule reward is also used analogous to a slot machine or lottery ticket. At unpredictable intervals a virtual "care package" or other potential source of additional support or reward becomes available on the display 30. If compliance has been adequate for a specific interval, the user can "open" the package. If not, the opportunity is lost.

[0036] Another advantage of the charitable support mode is that the reacting individual is in a highly dependent position. Those who are supported by children' s charities often cannot get adequate nutrition, and are at risk of starvation if the charitable support is not maintained. And, medication adherence is effectively triggered with punishment compared to rewards. The present mode incorporates a contingent monetary fine that directly harms individuals in need. Another advantage of this mode is that actual help is delivered in this option, which engages altruistic motivating factors. Specific causes and organizations, such as children's hospitals, disaster relief organizations, etc., could potentially co-brand a device of this nature in order to raise money. This embodiment may be especially well-suited to people who already engage in charitable giving.

[0037] In addition, the current mode need not display pictures which are overly distressing. This is managed by showing only children who had received the benefit of charitable donations and were therefore happy, healthy, well-nourished, and well-clothed (FIG. 1). The negative pictures in response to noncompliance would differ only in the emotional expression. The proximity detector 114 allows a video to be triggered during states of noncompliance in which the child looks up, makes eye contact with the camera, and manifests a sad expression. Other visual appeals for help are also used. Alternatively, during states of compliance, the proximity detector 114 can trigger a smile, wave or other sign of greeting upon the user's approach.

[0038] The user could dial a telephone number periodically or go online, and enter a code to access his/her account or to indicate how much money would go to the charity. Alternatively, at the end of the year when a new donation is made, the new media card would be sent with a return envelope to mail back the previous media card, which would be coded with the amount of money earned and lost. It should be noted that the amount of money lost for each day of noncompliance can be small. The symbolic nature of the lost money and the emotional impact of the child's reaction still provides motivation.

[0039] In the model mode, the device is preloaded with photographs of models as reacting individuals. This is the simplest mode, since no additional steps need to be taken by the patient to set it up and begin to use it. High quality photos can be pre-loaded onto the processor 42, and sophisticated morph sequences can be included that do not require the device to perform complex processing. The use of an animated character (FIG. 2c) as a reacting individual would be particularly appropriate for children who need to take long-term medication. Characters from popular children's books or movies would incorporate a preexisting emotional relationship for children who had developed an attachment to the characters. But, because the patient would have no preexisting social connection to the reacting individual (except in the case of licensed characters for children described above), the emotional impact would be smaller. For children, the reacting individual can be a puppy (FIG. 2b) or other pet that becomes sad, or even sick, in response to nonadherence.

[0040] As an option, the present invention can be provided with an alarm. However, many alarms are intrusive and unpleasant, and people stop using them after a short period of time. More importantly, alarms are able to remind people to take medication, but they do not address the underlying problem of motivation. Alarm reminders are set to occur one or more times per day, every day, despite the fact that non-adherence is episodic. Consequently, alarm notifications tend to be irrelevant, and are therefore liable to be screened out by the brain.

[0041] The adherence device uses emotional reactions related to social circuits in the brain to make adherence emotionally rewarding by linking adherence to the gratifying experience of helping someone in need. Acting on compassion stimulates dopamine circuits in the brain associated with pleasure. In addition, non-adherence creates an aversive reaction through feelings of guilt. The aversive stimulus is delivered only when non-adherence occurs, therefore it remains relevant on an ongoing basis. This is in contrast to an alarm reminder system that goes off whether or not it is needed, and therefore can be screened out by the brain as irrelevant.

[0042] The adherence device described in this disclosure is self-contained. It does not require an Internet connection or the resource-intensive involvement of trained healthcare workers. However, the processor 42 can also be connected to the Internet or can call in to a central location which maintains an account for the user. The user can track his/her account, online, by telephone or by being periodically downloaded to the display device 30, and can select from amongst various charities. The user can thereby track the amount contributed to the charity, the adherence level, receive information about the charity or use of the donations, etc. The system can also retrieve pictures online, and the user can control the operation of the device by adding / removing / changing medication prescriptions, including the time at which the medication(s) is to be taken. New media, including pictures and video, can periodically be added. The media can be stored in the memory 48.

[0043] It uses social punishment as a response to non-adherence, and therefore makes the behavior aversive rather than rewarding. In addition, delivering the stimulus at the time of non-adherence has a greater effect on behavior.

[0044] This device can be used to motivate other health behaviors besides medication adherence. For example, the device could be connected to a blood pressure monitor or a glucose monitor to respond to both the frequency of measurements as well as to the value of the measurement itself (i.e. , a blood sugar within the desirable range). The system can be applied to weight scales to help motivate weight loss, and exercise machines to motivate a regular schedule of exercise. It can communicate (wired or wirelessly) with a pedometer or sensing technology inside shoes to help people who set walking goals. It can also be paired with cell phone location, cell phone GPS or other GPS technology to react positively to presence within a doctor's office, gym, AA meeting, library (for students who need to maintain a regular study schedule), or other desirable location. It can be connected to mapping/directory services to react adversely to presence in a bar, fast food restaurant, drug- dealing neighborhood, or other businesses that the user desires motivational help in avoiding. The user can either set those locations manually, or they can be preprogrammed into the system 5.

[0045] Using the animal mode (FIG. 2b), licensed character mode (FIG. 2c), or other modes suitable to children, the device 5 can be set to react to codes input by adults who want to motivate specific behaviors in children. These behaviors may include, for instance, getting to bed on time, completing homework, keeping the room clean, eating healthy food, and engaging in physical activity.

[0046] The device responds to a signal generated by the pill container being opened, however it does not sense if a pill has been removed or ingested. But, the device is typically not used by people who are actively opposed to taking their medication. Most non-adherence is due to people placing a low priority on taking medication rather than an actual aversion to it.

[0047] Rather than creating an emotional bond to an inanimate object, the current device utilizes social circuitry in the brain which is stimulated by human emotional facial expression. The one exception to this is when the device runs in model mode and uses a licensed animated, such as a non-human character from children' s literature or other media as the reacting individual. However, this approach also exploits a pre-existing relationship with an anthropomorphized character. The present invention does not create a relationship with the device itself. In yet another embodiment, the reacting individual can be a custom-made avatar, such as one which represents an individual person. The avatar can have customized hair, facial features, skin color, etc., which allows the user to create a character that has maximum emotional connection for them.

[0048] FIG. 4(a) shows an embodiment of the device 5. The LCD screen 30 that displays the photographs of the reacting individual can measure approximately 7 inches diagonally. It can be equipped with an SD card 48 to store relevant media, pill containers 14 with switches to detect opening events, a control panel, and processing chip. The compartments 14 can be color coded and / or have lights 112 on them. The compartment covers 12 have a small lip 13 which projects from the bottom end of the cover 12. The lip 13 operates as a handle to facilitate the opening of the compartment 14.

[0049] As shown in FIGS. 4(a), (b), the device 5 has a one-piece housing 50 which includes a head 52, neck 54 and base or body 56. The head 52 houses the display 30, which is presented at the front face of the head 52. The rear of the head 52 is curved backward, and leads into the neck 54. The neck 54 extends downward from the rear portion of the head 52 and is narrowed inward. The body 56 broadens outward to form a wide base to provide a sturdy support for the head 52 and sufficient space for the compartments 14. The body 56 is somewhat oblong and the bottom has an oval cross section. The entire housing 50 is configured to have a sleek design with soft curves that evoke human appearances, characteristics and/or shapes. The configuration enhances the emotional connection to the device. People unconsciously develop relationships with objects, particularly personal technology objects, and the visual appeal of the device 5 enhances the strength of the emotional connection. The housing 50 is also ergonomic and easy to use for an elderly person.

[0050] A control or menu button 34 is provided which brings up the control menu on the display to allow certain functions to be accessed on the touch screen. The functions include turning the device on and off, setting the times and/or frequency of medication dosing, entering the device into a "vacation" mode in which it becomes idle for a set number of days, selecting a reacting individual, setting the time, accessing historical data on adherence levels, accessing drug information, and other control functions and information.

[0051] One operation of the control panel activated by the menu button 34, is shown in FIG. 5. The control panel can be implemented on the display device 30 or as a separate display. As shown, the control panel can be used to set the times for the medication to be taken. In the embodiment of FIGS. 4 and 5, five compartments 14 are provided, which are designated on the control panel (an optionally also on the housing in FIG. 4) as A-E. Each compartment 14 is intended to receive one medication. The user places the appropriate number of pills in the compartment 14 for a given day or week, and then indicates on the control panel how many times a day the pills are to be taken. If the user takes fewer than five different types of medication, then the unused compartments can be designed as "not used."

[0052] Once the number of times per day is indicated, the control panel can move to another screen to indicate how many pills are to be taken at each occasion. The control panel can also optionally present yet another screen which confirms the time of day that the medicine is to be taken. The times can be manually set by the user, or the processor 42 can determine the appropriate times. For instance, if the user indicates that a certain medication in compartment A 14 is to be taken twice a day, the processor 42 can determine that the pill should be taken at 9am and 6pm, for instance. In addition, the control panel can be used to download pictures from the memory slot 46, from memory 48, or from the Internet. It can also be used to control operation of the device 5 in accordance with the other features of the invention described herein.

[0053] Faces are used as emotional stimuli because the brain contains specialized structures designed to react to facial emotional (dorsal region of the limbic system) that strongly influence neural systems of motivation (nucleus accumbens) and action (striatum and motor cortex).

[0054] The device does not affect cognitive or memory function, but instead affects emotional circuits which influence motivation and action. Cognitive understanding of the benefits of a behavior leads to action when a desire to engage in the behavior exists. The desire may be motivated by the expectation of physical reward (for example eating food), emotional reward (for example, peer approval), or exclusively by the intellectual knowledge that the behavior ought to be performed. In the last case will power is required to initiate and maintain the activity. Will power is not required in the first two instances.

[0055] The medication adherence device is designed to cause guilt when the user does not take medicine as prescribed by simulating progressively increasing emotional pain and distress in a person who is placed in a vulnerable, dependent position. Photographs of facial expressions of emotion are used because our brains have evolved to be highly sensitive to and vigilant of this type of social information. Unlike will power, which has an effect that diminishes over time, the effect of the operant conditioning model increases over time.

Pairing an emotionally neutral stimulus (e.g. , medication noncompliance) with a distress- evoking aversive stimulus (apparent harm to a dependent individual) is a form of classical conditioning. Eventually, the noncompliance alone evokes distress, and is therefore avoided.

[0056] Thus, one element of the invention is that the user must keep a "survival element" alive and healthy by taking medication as prescribed. This interaction engages circuits in the brain responsible for nurturing and caretaking behavior. These circuits strongly influence actions and decisions because they are essential for successful gene propagation and species survival. The device is unique because it simulates dependence on the user. If the user's actions are not in accordance with target behaviors then the simulated creature gets sick and dies. [0057] The current invention generates caretaking emotions in the user. An alarm is a piece of information that has intellectual relevance. The current invention motivates behavior using emotion, which has more potent effects. Alarms have no way of exciting caretaking emotions in a user. The invention simulates dependence, rather than caretaking, and uses the triggered emotion as the primary motivation tool (as opposed to the direct presentation of the medication as the motivator).

[0058] The current invention stimulates emotions in users that are related to relationships and is designed to use a relationship with a human being represented by a photograph rather than a relationship with an inanimate object.

[0059] The current device does not require WiFi or Ethernet networks in the home, and can be used by people who have difficulty managing the complexity of a network-connected device. Networked devices can infringe on a patient's privacy, and many patients do not like the idea of their medication use being remotely monitored, especially because medication non-adherence is a behavior that provokes criticism. The present device does not communicate the day-to-day details of health behaviors to other parties. Finally, the invention eliminates the costs associated with ongoing monitoring and contact by a third party.

[0060] The pictures can be tailored according to the specific test taker' s background, life style, personality traits, etc. The device can screen for optimum pictures to be used. The screening test provides a scheme for identification and selection of such pictures. The patient' s emotional response can be measured to each picture or type of picture, such as by utilizing subjective patient rating scales in which patients are asked to rate the degree to which they feel a connection with the individual in the picture. The degree to which the distressed picture makes them experience unpleasant emotions. Objective measures can also be used, including measures of skin conductance, heart rate, muscle activation, and respiratory rate. Neuroimaging techniques, such as functional MRI offer a particularly effective way of measuring objective emotional responses, in which the degree of social connection and emotional distress can be measured separately.

[0061] Thus, the system 5 can be implemented by the processor 42 to perform various functions and operations in accordance with the invention. The device 5 can be a standalone unit, as shown, or can be implemented at a personal computer (PC) or server. All or parts of the system and processes can be implemented at the processor 42 by software or other machine executable instructions which is stored on or read from computer-readable media for performing the processes described. Computer readable media may include, for instance, hard disks, floppy disks, DVD, memory stick, CD-ROM, dowloadable file, read-only memory (ROM) or random-access memory (RAM).

[0062] In yet another embodiment of the invention, more than one system 5 can be provided which communicates with other systems 5, such as through a wired or wireless connection. The systems 5 can be provided at a same location as each other or at locations which are remote from each other. Each device can have a unique identification number to allow for directed communication to that device. Partners can be established, for instance, identifying a partner on a central website and incorporating that information into the processor 42. Users interested in finding an adherence support partner can do so either anonymously through the use of an Avatar, or if they choose they can post information about themselves similar to the type of information posted on a social media web site. In the first case, pairing can be done in an automated fashion, in the second, invitations are sent out by users interested in partnering with a specific individual.

[0063] In addition, each device can have a partnering mode, such that the adherence of one partner can affect the other. Partners may be visually represented with pictures, video or as an avatar. Partners would be encouraged to support one another with their adherence. Like other modes, the behavior of the user has a potential impact on another person, thereby increasing the emotional impact compared to when behaviors have only self-impact. For example, if an elderly user were partnered with a child suffering from a chronic disease, each would know if the other has "set a good example" or not. If the elderly person failed to take medication, that person would receive a warning, for example, "Please help John take his medication today. He sees that you didn't take yours, and it can be helpful when partners support one another. Remember that John suffers from asthma, and like all kids, it's hard for him to accept that he's different, and needs pills every day. But asthma can be a life- threatening disease, and the best way for John to stay healthy is to make sure he takes his medication every day." The images displayed by a device can also be affected by the compliance of the partner, and/or the partner avatar can change depending on the compliance of that partner.

[0064] Individuals out of compliance are gently reminded that they can help their partner by setting a good example. The partner of an out-of-compliance individual is informed, and encouraged to send them a supportive message. They can choose from a list of standard messages or type a personalized message using an on-screen keyboard. The act of helping a partner stay in compliance also helps to increase compliance in the helping individual. If an individual encourages compliance in another person, then engages in noncompliant behavior him or herself it leads to what is termed "cognitive dissonance," which causes emotional discomfort creating a motivational drive to reduce the dissonance.

[0065] Partners can be known or remain anonymous by using pseudonyms. In the context of this privacy protection, they will have the option of sharing personal information with their partner. For example, the following message can be transmitted to a partner device: "John started spring break today. He and his family are going to visit his aunt, uncle, and cousins. John has not had to go to the emergency room for an asthma attack in 6 months, and he's feeling great. He and his family appreciate your being part of his good health." [0066] The following references are hereby incorporated by reference: Bartels, A., Zeki, S., 2004. The neural correlates of maternal and romantic love. Neuroimage 21, 1155-1166; Breiter, H.C., Gollub, R.L., Weisskoff, R.M., Kennedy, D.N., Makris, N., Berke, J.D., Goodman, J.M., Kantor, H.L., Gastfriend, D.R., Riorden, J.P., Mathew, R.T., Rosen, B.R., Hyman, S.E., 1997. Acute effects of cocaine on human brain activity and emotion. Neuron 19, 591-611; Center for International Disaster Information, 2008. Majority of Americans are compassionate and giving to those in need; Chodon Group, 2007, as reported in New Jersey's The Star Ledger, July 8, 2007; Cutting Edge Information, 2006. Pharmaceutical Patient Adherence and Disease Management: Program Development, Management and

Improvement; Feinberg, R.A., 1986. Credit cards as spending facilitating stimuli: A conditioning interpretation. The Journal of Consumer Research 13, 348-356; Insel, T.R., 2003. Is social attachment an addictive disorder? Physiol Behav 79, 351-357; Insel, T.R., Young, L.J., 2001. The neurobiology of attachment. Nat Rev Neurosci 2, 129-136;

Lorberbaum, J.P., Newman, J.D., Dubno, J.R., Horwitz, A.R., Nahas, Z., Teneback, C.C., Bloomer, C.W., Bohning, D.E., Vincent, D., Johnson, M.R., Emmanuel, N., Brawman-

Mintzer, O., Book, S.W., Lydiard, R.B., Ballenger, J.C., George, M.S., 1999. Feasibility of using fMRI to study mothers responding to infant cries. Depress Anxiety 10, 99-104;

Mattson, B.J., Williams, S., Rosenblatt, J.S., Morrell, J.I., 2001. Comparison of two positive reinforcing stimuli: pups and cocaine throughout the postpartum period. Behav Neurosci 115, 683-694; McHorney, C.A., 2009. The Adherence Estimator: a brief, proximal screener for patient propensity to adhere to prescription medications for chronic disease. Curr Med Res Opin 25, 215-238; Mermelstein, R., Cohen, S., Lichtenstein, E., Baer, J.S., Kamarck, T., 1986. Social support and smoking cessation and maintenance. J Consult Clin Psychol 54, 447-453; Ockene, J., Ma, Y., Zapka, J., Pbert, L., Valentine Goins, K., Stoddard, A., 2002. Spontaneous cessation of smoking and alcohol use among low-income pregnant women. Am J Prev Med 23, 150-159; Renvoise, P., Morin, C, 2007. Neuromarketing: Understanding the Buy Buttons in Your Customer's Brain. Thomas Nelson, Nashville, TN; Sherman, F.T., 2007. Medication nonadherence: a national epidemic among America's seniors. Geriatrics 62, 5-6; Thaler, R.H., Tversky, A., Kahneman, D., Schwartz, A., 1997. The effect of myopia and loss aversion on risk taking: An experimental test. Quarterly Journal of Economics 112, 647-661 ; and World Health Organization, 2003. Adherence to Long-Term Therapies. World Health Organization, Geneva, Switzerland.

[0067] The foregoing description and drawings should be considered as illustrative only of the principles of the invention. The invention may be configured in a variety of shapes and sizes and is not intended to be limited by the preferred embodiment. Numerous applications of the invention will readily occur to those skilled in the art. Therefore, it is not desired to limit the invention to the specific examples disclosed or the exact construction and operation shown and described. Rather, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims

Claims:

1. A medication adherence device, comprising:

a display device for displaying at least one image;

a medication dispenser having a switch for detecting the dispensing of medication; and,

a processor in communication with the switch, said processor configured to determine whether a user is in compliance with a medication prescription, and control the display device to display the at least one image in response to the determination.

2. The device of claim 1 , wherein said processor is further configured to determine that the user is not in compliance with the medication prescription if the switch does not detect the dispensing of medication at a predetermined time period, and in response control the display device to display a first image depicting a first emotional state.

3. The device of claim 2, wherein said processor is further configured to determine that the user is in compliance with the medication prescription if the switch detects the dispensing of medication within the predetermined time period, and in response control the display device to display a second image depicting a second emotional state.

4. The device of claim 3, wherein the first and second images are pictures are of a loved one.

5. The device of claim 1, further comprising a storage device for storing the at least one image.

6. The device of claim 1 , wherein the storage device comprises a memory.

7. The device of claim 1, wherein said at least one image comprises a first picture depicting a first state and a second picture depicting a second state.

8. The device of claim 7, wherein the first state is taken from the group comprising happy, excited, pleased or satisfied, and the second state is taken from the group comprising sad, depressed, upset, or dissatisfied.

9. The device of claim 1, wherein said display device displays at least two images.

10. A medication adherence device, comprising:

a medication dispenser having a switch for detecting the dispensing of medication; and,

a processor in communication with the switch, said processor configured to determine whether a user is in compliance with a medication prescription, and determine a charity contribution based on whether the user is not in compliance with the medication prescription.

11. The device of claim 10, further comprising a display device for indicating the charity contribution.

12. The device of claim 10, wherein said processor increases the charity contribution in response to determining that the user is in compliance with the medication prescription.

13. The device of claim 12, wherein said processor decreases the charity contribution in response to determining that the user is not in compliance with the medication prescription.

14. The device of claim 10, wherein said processor is remote from said medication dispenser.

15. The device of claim 14, wherein said processor is accessed through the Internet.

16. The device of claim 10, wherein said processor determines the total charity contribution for the user.

17. The device of claim 10, further comprising a display device for displaying an image in response to the processor determining that the user is in compliance with the medication prescription.

18. The device of claim 10, wherein the device has a housing which enhances an emotional connection with a user.

19. The device of claim 18, wherein the housing has soft curves and includes a head, neck and body.

20. A medication adherence system for use with a medication dispenser having a switch for detecting the dispensing of medication, comprising:

a processor in communication with the medication dispenser over a network, the processor configured to determine whether a user is in compliance with a medication prescription, and determine a charity contribution based on whether the user is in compliance with the medication prescription.

21. The system of claim 20, wherein said network comprises the Internet.

22. A medication adherence device, comprising:

an audible or visual alert device;

a medication dispenser having a switch for detecting the dispensing of medication; and,

a processor in communication with the switch, the processor configured to determine whether a user is in compliance with a medication prescription, and control the alert device to generate a signal which creates guilt in the user when the processor determines that the user is not in compliance with the medication prescription.

23. A method of making a personalized medical compliance device comprising the steps of: selecting using a processor, a plurality of pictures according to a patient's personal life style and background; displaying on a display device, the pictures to the patient; recording at the processor, the patient's response to each picture; selecting at the processor, the picture eliciting the optimum response and emotional interaction with the patient; and implementing at the processor, the selected picture into the medical device.

24. The method of claim 23, wherein the personalized medical compliance device motivates the patients to take medication on a regular time interval and for an extended period of time.

25. A medication adherence system, comprising: a first medication adherence device having a first display device for displaying images, a first mediation dispenser having a switch for detecting the dispensing of medication, and a first processor in communication with the switch, said first processor configured to determine whether a user is in compliance with a first medication prescription, and control the first display device to display the at least one image in response to the determination, said first medication adherence device further having a first communication device; and, a second medication adherence device having a second display device for displaying images, a second mediation dispenser having a switch for detecting the dispensing of medication, and a second processor in communication with the switch, said second processor configured to determine whether a user is in compliance with a second medication prescription, and control the second display device to display the at least one image in response to the determination, said second medication adherence device further having a second communication device configured to communicate with said first communication device.

26. The system of claim 25, wherein said second processor is further configured to communicate the compliance of said second medication adherence device to said first processor, and said first processor is configured to display an image in response to the determination of the second processor.

27. The system of claim 25, wherein said first processor is configured to display a message on said first display device based on the compliance determined by the second processor.