AU2015101017A4 - Care management program compliance - Google Patents

Abstract

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 30 A method for managing compliance of a user with a care management program, the care management program including one or more behavioural requirements, the method including, in one or more electronic processing devices: receiving, via a communications network, behavioural data indicative of one or more behaviours of the user, the behavioural data including activity information obtained from a activity sensing device worn by the user and dietary information regarding the diet of the user; determining a degree of compliance with the care management program using the behaviour data; periodically generating a message at least partially in accordance with the degree of compliance, the message including at least one of motivational messages, encouragement to improve compliance, recommendations to improve compliance and an indication of the degree of compliance; and transferring the at least one message to the user via a communications network. Fig. 1A Receive behaviour 100 data Determine degree of 110 compliance Generate message 120 Transfer message to 130 user Fig. 1

Description

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 CARE MANAGEMENT PROGRAM COMPLIANCE Background of the Invention [0001] This invention relates to a method and apparatus for managing compliance of a user with a care management program. Description of the Prior Art [0002] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that the prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates. [0003] Diabetes is a group of metabolic diseases in which there are high blood sugar levels over a prolonged period. Untreated, diabetes can lead to many complications including acute complications such as diabetic ketoacidosis and hyperosmolar coma and serious long-term consequences such as heart disease, stroke, kidney failure, foot ulcers and damage to the eyes. [0004] Globally, as of 2013, an estimated 382 million people have diabetes worldwide, with Type II diabetes making up about 90% of the cases. The economic costs of diabetes globally was estimated in 2013 at $548 billion and in the United States in 2012 $245 billion. Despite this, in many cases Type II diabetes can be largely managed or mitigated through healthy diet, physical exercise, not using tobacco, and being a normal body weight. [0005] Whilst attempts have been made to educate the public regarding the benefits of a healthy lifestyle, particularly in the case of diabetes suffers, a large number of people continue to eat poorly, smoke and exercise infrequently, leading to far greater health expenditure than should be required. There are a large number of reasons for this, but typically this is because individuals do not understand the impact of their behaviours on their condition, what behaviours might be beneficial, or become disillusioned when no immediate benefits are apparent from modification of their behaviour.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -2 [0006] Similar issues also exist for a range of other conditions, such as addictions, depression or the like. Accordingly, it is desirable to find a mechanism to assist individuals in adhering to care management programs. Summary of the Present Invention [0007] In one broad form the present invention seeks to provide a method for managing compliance of a user with a care management program, the care management program including one or more behavioural requirements, the method including, in one or more electronic processing devices: a) receiving, via a communications network, behavioural data indicative of one or more behaviours of the user, the behavioural data including: i) activity information obtained from a activity sensing device worn by the user; ii) dietary information regarding the diet of the user; b) determining a degree of compliance with the care management program using the behaviour data; and, c) periodically generating a message at least partially in accordance with the degree of compliance, the message including at least one of: i) motivational messages; ii) encouragement to improve compliance; iii) recommendations to improve compliance; and, iv) an indication of the degree of compliance; and, d) transferring the at least one message to the user via a communications network. [0008] Typically the method includes: a) comparing the behavioural data to program criteria forming part of the care management program; and, b) determining a degree of compliance in accordance with the result of the comparison. [0009] Typically the method includes: a) comparing the activity information to at least one activity criterion; H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -3 b) determining an activity compliance in accordance with the result of the comparison; c) comparing the dietary information to at least one dietary criterion; d) determining dietary compliance in accordance with the result of the comparison; and, e) determining the degree of compliance in accordance with the dietary and activity compliance. [0010] Typically the method includes: a) determining an activity compliance score; b) determining a dietary compliance score; and, c) determining the degree of compliance in accordance with the activity and dietary compliance scores. [0011] Typically the method includes: a) generating a compliance indicator indicative of a degree of compliance; and, b) at least one of: i) recording the compliance indicator; and, ii) displaying the compliance indicator to the user. [0012] Typically the method includes: a) obtaining user details indicative of at least one of: i) at least one condition; ii) a progression of at least one condition; iii) at least one physical characteristic of the user; and, b) determining a care management program at least partially in accordance with the user details. [0013] Typically the method includes: a) selecting a care management program for a particular condition; and, b) modifying the care management program based on the at least one physical characteristic.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -4 [0014] Typically the method includes modifying the care management program by modifying at least one program criterion. [0015] Typically the method includes generating first and second messages each day. [0016] Typically each message includes a motivational message. [0017] Typically the first message defines at least one goal corresponding to an activity or dietary requirement and wherein the second message is indicative of whether the goal is met. [0018] Typically the method includes generating the message in accordance with at least one of: a) a current degree of compliance; and, b) one or more previously determined degrees of compliance. [0019] Typically the method includes: a) selecting a message template at least partially in accordance with the degree of compliance; and, b) modifying the message template to personalise the message for the user. [0020] Typically the method includes: a) determining dietary and activity recommendations to be displayed to the user; and, b) causing an indication of the dietary and activity recommendations to be displayed to the user. [0021] Typically the method includes determining dietary and activity recommendations at least partially in accordance with a degree of compliance. [0022] Typically the method includes: a) determining at least one measured value for at least one quantifiable parameter associated with a condition of the user; and, b) using the measured value to assess an effectiveness of the care management program.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -5 [0023] Typically the method includes: a) determining changes in measured values for the at least one quantifiable parameter during participation in the care management program; b) comparing changes in the measured values to the degree of compliance during the program; and, c) using the results of the comparison to determine success of the care management program. [0024] In another broad form the present invention seeks to provide apparatus for managing compliance of a user with a care management program, the care management program including one or more behavioural requirements, the apparatus including one or more electronic processing devices that: a) receive, via a communications network, behavioural data indicative of one or more behaviours of the user, the behavioural data including: i) activity information obtained from a activity sensing device worn by the user; ii) dietary information regarding the diet of the user; b) determine a degree of compliance with the care management program using the behaviour data; and, c) periodically generate a message at least partially in accordance with the degree of compliance, the message including at least one of: i) motivational messages; ii) encouragement to improve compliance; iii) recommendations to improve compliance; and, iv) an indication of the degree of compliance; and, d) transfer the at least one message to the user via a communications network. [0025] Typically the apparatus includes at least one end station that communicates with the one or more processing devices, the end station being for at least one of: a) providing behavioural data from the user; and, b) displaying messages to the user. [0026] Typically the apparatus includes at least one activity sensing device that communicates with the one or more processing devices via the end station.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -6 Brief Description of the Drawings [0027] An example of the present invention will now be described with reference to the accompanying drawings, in which: [0028] Figure 1 is a flow chart of an example of a method of managing compliance of a user with a care management program; [0029] Figure 2 is a schematic diagram of an example of a distributed computer architecture; [0030] Figure 3 is a schematic diagram of an example of a processing system of Figure 2; [0031] Figure 4 is a schematic diagram of an example of a end station of Figure 2; [0032] Figure 5 is a flow chart of an example of a method of registering a user with a care management program; [0033] Figure 6 is a flow chart of an example of a method of assessing behavioural data; [0034] Figure 7 is a flow chart of an example of a process for providing recommendations; [0035] Figure 8 is a flow chart of an example of a method for providing messages to a user; [0036] Figure 9 is a flow chart of an example of a method for assessing the effectiveness of a care management program; and, [0037] Figure 10 is a schematic diagram of an example of the functionality of a system for managing compliance of a user with a care management program. Detailed Description of the Preferred Embodiments [0038] An example of a method and apparatus for managing compliance of user with a care management program will now be described with reference to Figure 1. [0039] In this example, it is assumed that the process is performed at least in part using one or more electronic processing devices forming part of one or more processing systems, which are in turn connected to one or more end stations via a network architecture, as will be described in more detail below. [0040] For the purpose of the example, the term "care management program" will be taken to mean a defined series or sequence of behaviours that can be taken by an individual, including but not limited to dietary, activity and other health related behaviours, that can be used in managing, mitigating, reversing or compensating for a medical, biological or health related condition, such as a disease, obesity, addiction, or the like. The term "user" is used to refer to H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -7 an individual that is interacting with the processing system(s) to participate in the care management program. [0041] In this example, at step 100 behavioural data is received by the one or more electronic processing devices via a communications network. The behavioural data is typically indicative of one or more behaviours of the user that are relevant to the care management program, and therefore typically include but are not limited to activity information obtained from an activity sensing device worn by the user and dietary information regarding a diet of the user. It will therefore be appreciated that the behavioural data could be in any appropriate form, depending on the nature of the behaviour. So for example, in the case of the activity information, the behaviour data typically includes sensor data provided by the activity sensing device which relates to movement or other forms of activity. In contrast, the dietary information could include a list and/or quantity of foods consumed by the user, an indication of a numbers of calories consumed, or the like. [0042] The manner in which the behaviour data is provided by will vary upon the preferred implementation and how the data is collected. So for example, the activity information can be uploaded from the activity sensing device to the one or more electronic processing devices directly, or via an intermediate application executed by a end station, mobile phone or the like. In contrast, the dietary information is typically entered manually by the user using a suitable user interface as will be described in more detail below. [0043] In any event, it will be appreciated that any mechanism for obtaining the activity or dietary information could be used and also that the behaviour data could include additional information, such as information relating to levels of smoking or alcohol consumption and that reference to activity and diet, whilst exemplary are not intended to be limiting. [0044] At step 110 a degree of compliance with the care management program is determined using the behaviour data. Thus, this typically involves comparing the activity and/or dietary information to pre-determined activity or dietary criteria indicative of the requirements of the program. Thus, the electronic processing device(s) will examine whether the amount of activity performed meets a required amount of activity defined as part of the program, and similarly, whether the food and beverage consumed meets dietary requirements, such as a set H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 number of calories of food, or more typically, set quantities of foods across different food groups, such as vegetables, fruits, whole grains, or protein. [0045] The dietary and activity requirements of the program are typically dependent on the condition suffered by the individual and may also vary depending on physical characteristics of the user, as will be described in more detail below. These are usually based on researched dietary and activity plans such as Harvard's Healthy Eating Plate or the like. [0046] At step 120 the electronic processing device(s) periodically generate a message at least partially in accordance with the degree of compliance, with this being transferred to the user via the communications network at step 130. The messages typically include motivational messages, encouragement to improve compliance, recommendations to improve compliance, or an indication of a degree of compliance and may also include additional information, such as advice or recommendations, as will be described in more detail below. [0047] The messages can be generated in any suitable manner, and this can be performed for example using a template message which is then populated with suitable information to tailor the message for the user. This may be performed automatically and/ or manually by an operator of the system, allowing for a wide variety of flexibility in the way messages are created. The messages could also be transferred to the user in a variety of manners, including for example, SMS messaging, email, for display via an App on a mobile phone or other communications device, or the like. [0048] Thus, in this process messages are periodically generated and then "pushed" to the user via a suitable communications protocol, to thereby provide feedback to the user regarding their compliance, as well as encouraging them to improve compliance and optionally providing recommendations to assist with this process. For example, in this event that the user's exercise or activity is insufficient on any one day, the message can include a recommendation to increase the level of activity for the following day and further provide some examples of how this may be achieved. This has a number of potential benefits. [0049] Importantly, the messaging process provides regular encouragement to the user, which from a psychological perspective can make a significant improvement in participation rates in the care management program. In this regard, without regular positive feedback, H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -9 participants often become demotivated, causing them to drop out of the program before any potential benefits become apparent. However, by providing regular messages with a motivational message, this can significantly improve ongoing participation rates, leading to improved outcomes. [0050] Additionally, the messaging process vastly simplifies the process for the user in assessing whether or not they are in compliance with the care management program, by effectively allowing the assessment to be performed automatically by the processing device(s), thereby avoiding the need for the user to understand the level of activity they need to perform, or to make an assessment of the particular nutritional content of their diet. This reduces the burden on the user, thereby making their continued participation in the care management program more likely. [0051] A further benefit is that in the event that the user fails to comply with the care management program, recommendations can be provided for how they can mitigate their deviation from the compliance. For example, if they have not performed sufficient activity on one day, a recommendation can be performed that further activity is performed on a subsequent day. This can then be tracked to determine if they returned to compliance with the program. Similarly, in terms of dietary compliance, in the event that the user eats food that does not comply with the care management program, corrective measures can be taken, for example to eat healthier foods over subsequent days. [0052] A further benefit of the above described process is that compliance with the program can be monitored allowing an assessment to be made as to the impact of success of failure to comply with the program. For example, proposed criteria for the program can be assessed to determine whether or not they are effective at providing the required degree of care management. Thus, in the case of diabetes or other similar related disorders, the process can involve examining blood sugar levels or the like associated with the user by performing periodic tests, such as once every two or three months. Results of the test can then be examined together with historical compliance figures for the user to ascertain whether a particular diet or exercise regime is successful in helping to manage the condition. [0053] A number of further preferred features will now be described.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 10 [0054] In one example, the method includes comparing behavioural data to program criteria forming part of the care management program and determining a degree of compliance in accordance with the results of the comparison. This typically involves comparing activity information to at least one activity criterion and determining activity compliance in accordance with the results of the comparison, as well as similarly comparing the dietary information to at least one dietary criterion and determining dietary compliance in accordance with the results of the comparison. This in turn allows an overall degree of compliance to be determined in accordance with dietary and activity compliance. Thus this allows compliance for both diet and activity to be assessed independently, with this being used to judge an overall level of compliance, which can be used to provide independent feedback on each of activity and diet to be provided, as well as allowing for independent verification of whether activity or dietary compliance is more important, as will be described in more detail below. [0055] In a further example, the method includes determining an activity compliance score, determining a dietary compliance score and determining the degree of compliance in accordance with the activity and dietary compliance scores. Thus, the degree of compliance can be quantified, which can in turn allow a degree of compliance / non-compliance to be assessed, as well as allowing an indicator indicative of the degree of compliance to be generated and also to assist in generating messages and recommendations, as will be described in more detail below. [0056] In one example, the method can include generating a compliance indictor indicative of a degree of compliance and recording and/or displaying the compliance indicator to the user. The compliance indictor could be in any appropriate form such as an indication of positive or negative compliance or an alphanumeric representation of an overall compliance score. In one example, the compliance indicator is a graphical representation at least partially based on the degree of compliance which is easy for user's to understand and interpret. [0057] The method can include obtaining user details indicative of one or more of any conditions suffered by the user, a progression of any conditions, and physical characteristic(s) of the user. Thus, this may involve a clinical assessment of the user to identify any conditions, as well as to assess other physical characteristics, such as gender, age, weight, H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 -11 height or the like, with the information being supplied by the user and/or a medical practitioner. This information can then be used to determine a care management program at least partially in accordance with the user details so that the care management program can be tailored for a particular individual. [0058] In particular, the method typically includes selecting a care management program for a particular condition and then modifying the care management program based on the physical characteristic(s) of the user. The nature of the modification will vary depending upon the preferred implementation but typically this would include modifying at least one program criterion such as a level of activity required, type of activity required, dietary requirements or the like. [0059] Thus, different care management programs can be defined for different conditions, with these then being further tailored based on physical characteristics of the user so as to ensure the care management programs is appropriate for the user. In this regard, it will be appreciated that individuals of different gender, age, weight or the like may have a different dietary requirements and/or may be capable of different levels of activity. Accordingly, this process allows the care management program to be tailored for users making it more likely that users will comply, whilst also ensuring that the care management program will provide effective outcomes for the users. [0060] Whilst any number of messages that can be generated, in one example, first and second messages are generated each day. These can then be provided at respective times of the day, such as by providing the first message in the morning and the second message later in the day. In this instance the first message can be used to define a motivational message to encourage participation for the following day, as well as a goal corresponding to an activity or dietary requirement, such as one of the program criteria, with the second message being used to indicate whether the goal is met. Thus, the user can be presented with a first message indicating a level of activity, and/or a particular diet for the day with the user then being provided with an indication of their degree of compliance during the day. [0061] Additionally and/or alternatively, at least one of the messages is typically generated in accordance with a degree of compliance and optionally one or more previously determined H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 12 degrees of compliance. Thus for example, the degree of compliance could indicate whether they have complied on the previous day but may also indicate whether the user has repeatedly failed or succeeded in complying with the care management program, to thereby provide the user with feedback regarding their compliance. [0062] As previously mentioned, messages may also include a motivational aspect to help assist the user in reaching their goal. [0063] The messages can be generated in any suitable manner. Typically a message template is selected partially in accordance with a degree of compliance and then this is modified to personalise the message for the user. Thus, a particular type of message can be selected based on whether or not the user has complied with the modification being performed based on user details so that the message is tailored for the specific user. [0064] Additionally, the method can include determining dietary and activity recommendations to be displayed to the user including an indication that the dietary and activity recommendations to be displayed. This can be performed as part of the message or may alternatively be performed separately, for example by having the user access a webpage or the like. The recommendations are typically determined based partially in accordance with a degree of compliance so that if a user has not been compliant, additional dietary or exercise requirements can be imposed upon the user to ensure that they return to effective care management. [0065] The method also typically includes determining at least one measured value for at least one quantifiable parameter associated with a condition of the user and then using the measured value to assess an effectiveness of the care management program. It will be appreciated that the at least one measured value could be provided as part of the user details. [0066] In any event, the method typically includes determining changes in measured values for the at least one quantifiable parameter, comparing changes in the measured values to a degree of compliance during the program and using the results of the comparison to determine the success of the care management program.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 13 [0067] In one preferred example the above described process is performed in order to assist users suffering from Type II diabetes. This is a particularly appropriate condition as symptoms can be mitigated significantly and progression of the condition reversed, or at least halted, through suitable diet and exercise. In this instance, the quantifiable parameter could be a measure of glycated haemoglobin (haemoglobin Alc, HbAlc, AIC, Hblc or HbAlc), which is indicative of average plasma glucose concentration over prolonged periods of time, although other suitable measures could be used. [0068] It will also be appreciated however, that the techniques could be applied to other conditions, such as addictions, obesity, breathing disorders, depression, or the like. [0069] In one example, the process is performed by one or more processing systems operating as part of a distributed architecture, an example of which will now be described with reference to Figure 2. [0070] In this example, a base station 201 is coupled via a communications network, such as the Internet 202, and/or a number of local area networks (LANs) 204, to a number of end stations 203. It will be appreciated that the configuration of the networks 202, 204 are for the purpose of example only, and in practice the base station 201 and end stations 203 can communicate via any appropriate mechanism, such as via wired or wireless connections, including, but not limited to mobile networks, private networks, such as an 802.11 networks, the Internet, LANs, WANs, or the like, as well as via direct or point-to-point connections, such as Bluetooth, or the like. [0071] In one example, the base station 201 includes a processing system 210 coupled to a database 211. The base station 201 is adapted to be used in receiving behaviour data, and assessing compliance with the care management program, generating messages and performing other associated actions, such as registering users, hosting information regarding diet and activity recommendations, or the like. In this example, the end stations 203 are adapted to communicate with the base station 201, allowing behavioural data to be submitted and to allow messages to be received. [0072] Whilst the base station 201 is a shown as a single entity, it will be appreciated that the base station 201 can be distributed over a number of geographically separate locations, for H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 14 example by using processing systems 210 and/or databases 211 that are provided as part of a cloud based environment. However, the above described arrangement is not essential and other suitable configurations could be used. [0073] An example of a suitable processing system 210 is shown in Figure 3. In this example, the processing system 210 includes at least one microprocessor 300, a memory 301, an optional input/output device 302, such as a keyboard and/or display, and an external interface 303, interconnected via a bus 304 as shown. In this example the external interface 303 can be utilised for connecting the processing system 210 to peripheral devices, such as the communications networks 202, 204, databases 211, other storage devices, or the like. Although a single external interface 303 is shown, this is for the purpose of example only, and in practice multiple interfaces using various methods (eg. Ethernet, serial, USB, wireless or the like) may be provided. [0074] In use, the microprocessor 300 executes instructions in the form of applications software stored in the memory 301 to allow the auction process to be performed, as well as to perform any other required processes, such as communicating with the end stations 203. The applications software may include one or more software modules, and may be executed in a suitable execution environment, such as an operating system environment, or the like. [0075] Accordingly, it will be appreciated that the processing system 210 may be formed from any suitable processing system, such as a suitably programmed end station, PC, web server, network server, or the like. In one particular example, the processing system 210 is a standard processing system such as a 32-bit or 64-bit Intel Architecture based processing system, which executes software applications stored on non-volatile (e.g., hard disk) storage, although this is not essential. However, it will also be understood that the processing system could be any electronic processing device such as a microprocessor, microchip processor, logic gate configuration, firmware optionally associated with implementing logic such as an FPGA (Field Programmable Gate Array), or any other electronic device, system or arrangement. [0076] As shown in Figure 4, in one example, the end station 203 includes at least one microprocessor 400, a memory 401, an input/output device 402, such as a keyboard and/or H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 15 display, and an external interface 403, interconnected via a bus 404 as shown. In this example the external interface 403 can be utilised for connecting the end station 203 to peripheral devices, such as the communications networks 202, 204, databases 211, other storage devices, an activity sensing device 410, or the like. Although a single external interface 403 is shown, this is for the purpose of example only, and in practice multiple interfaces using various methods (eg. Ethernet, serial, USB, wireless or the like) may be provided. [0077] In use, the microprocessor 400 executes instructions in the form of applications software stored in the memory 401 to allow communication with the base station 201, for example to allow data to be supplied thereto and messages to be received. [0078] Accordingly, it will be appreciated that the end stations 203 may be formed from any suitable processing system, such as a suitably programmed PC, Internet terminal, lap-top, hand-held PC, smart phone, PDA, web server, or the like. Thus, in one example, the processing system 210 is a standard processing system such as a 32-bit or 64-bit Intel Architecture based processing system, which executes software applications stored on non volatile (e.g., hard disk) storage, although this is not essential. However, it will also be understood that the end stations 203 can be any electronic processing device such as a microprocessor, microchip processor, logic gate configuration, firmware optionally associated with implementing logic such as an FPGA (Field Programmable Gate Array), or any other electronic device, system or arrangement. [0079] Examples of the process will now be described in further detail. For the purpose of these examples, it is assumed that the processing system 210 is a server that communicates with the end station 203 via a communications network, or the like, depending on the particular network infrastructure available. In particular, the server hosts webpages allowing the user to submit behavioural data, review recommendations and other information, and also generates and transfers messages to the end stations 203. For ease of explanation, it is also assumed that the end station 203 is a web-enabled communications device, such as a mobile phone or tablet.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 16 [0080] To achieve this the server 210 executes applications software for hosting webpages, assessing compliance and generating messages, with actions performed by the server 210 being performed by the processor 300 in accordance with instructions stored as applications software in the memory 301 and/or input commands received from a user via the I/O device 302, or commands received from the end station 203. [0081] It will also be assumed that the user interacts with the processing system 210 via a GUI (Graphical User Interface), or the like presented on the end station 203, and in one particular example via a browser application that displays webpages hosted by the server 210. Actions performed by the end station 203 are performed by the processor 401 in accordance with instructions stored as applications software in the memory 402 and/or input commands received from a user via the I/O device 403. [0082] However, it will be appreciated that the above described configuration assumed for the purpose of the following examples is not essential, and numerous other configurations may be used. It will also be appreciated that the partitioning of functionality between the end stations 203, and the base station 201 may vary, depending on the particular implementation. [0083] A further example of a method for managing compliance for use with the care management program will now be described with reference to the Figures 5 to 10. [0084] In this example, the user initially undergoes a registration process as will now be described with reference to Figure 5. [0085] At step 500, the user typically undergoes clinical assessment. Clinical assessment can be performed to diagnose the subject and in particular, assess a presence, absence or degree of any conditions the subject may have. As part of the clinical assessment, the user will typically undergo a measurement of one or more quantifiable parameters, such as performing a test to determine HbAlc levels or the like, depending on the condition of interest. The user may also be examined to determine physical characteristics forming part of the user details, for example to have their weight and height assessed, as well as to ensure that there are no other mitigating factors that will impact upon their ability to participate in the program. The clinical assessment is typically performed by a medical practitioner and this may be done prior to the medical practitioner referring the user for participation in the care management H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 17 program, although it will be appreciated that for some conditions clinical assessment may not be required, in which case self-assessment by the user may be sufficient. [0086] At step 510 user details are provided to the server 210. The user details may be provided in any suitable manner, and could be achieved by having the medical practitioner upload the user details on behalf of the user. Alternatively, the user may access a webpage hosted by the server 210 using an end station 203, and enter the relevant details into fields presented on the webpage. [0087] At step 520 the user is registered with the system, for example by having the server create a user account. As part of this process, the user details are typically stored in a database or other repository as part of a user profile, forming part of the user account, which may also include other information regarding the user, such as a name, address, demographic information, or the like. Additionally, the user may be able to set user preferences relating to the process. The preferences could include details of preferred or excluded types of activity, such as walking, running, cycling, or the like, as well as preferred or excluded types of food. The preferences can also be used to define the preferred messaging mechanism to be used, such as phone, SMS, email or the like, as well as associated contact details. [0088] The user is also typically assigned with relevant information, such as a user name and password or the like in accordance with standard registration procedures. During this process, an activity sensing device may also be associated with the user account, by having a device identifier associated with the user account, although alternatively this could be performed after the device has been provided to the user, as will be described in more detail below. [0089] At step 530, the server 210 operates to create a custom care management program for the user. The care management program is typically created based on the conditions suffered by the user and the user details. Thus, as previously described, the server 210 could access a plurality of template care management programs stored in a database or other similar repository, with a respective template being selected for use depending on the conditions suffered by the user. Thus a different template would be selected if the user has Type II diabetes as opposed an addiction. Once the template has been selected, criteria within the H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 18 template may be defined based on the user details and more typically on physical characteristics of the user. Thus it will be appreciated that levels of activity, and/or dietary criteria will typically be defined based on the user's weight, height, body mass index, gender and other similar characteristics. This tailoring of the program can be performed in any manner, and this could be achieved manually but more typically is performed based on set rules governing the criteria that should be selected for different user characteristics. The tailored program can then be stored as part of the user profile, although it will also be appreciated that more generic programs could alternatively be used depending on the preferred implementation. [0090] At step 540 details of the program can be provided to the user including any user registration details such as user name and password, as well as details of activity and/or dietary criteria. The program details are typically displayed by the server 210 via an appropriate webpage, such as a dashboard containing information specific to the user, and can be access at any time during the care management program to provide the user with guidance to ensure that care management criteria are met, as well as to display information regarding compliance so the user can review their progress even in the absence of messages. [0091] Additionally at step 550, the user is provided with an activity sensing device which is adapted to automatically sense exercise performed by the user. The activity sensing device can be of any appropriate form and could include for example a Fitbit wireless exercise or activity measuring device. As part of this process, if not already performed, the particular activity sensing device given to the user is typically associated with a user account so that data received therefrom is automatically recorded as being associated with the user. In one example, this is achieved by having the user install an App on their mobile phone, which then registers with the device, allowing activity data to be uploaded from the activity sensing device to the phone. The system can then be configured so the data is transferred onto the server 210, either directly from the mobile phone or via an intermediate server, as will be appreciated by persons skilled in the art. [0092] Following registration, the process of determining compliance with care management program can be performed as will now be described with reference to Figure 6.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 19 [0093] In this example, at step 600 the user selects to provide dietary data. This is typically performed on a daily basis and is a largely manual process achieved by having the user select an appropriate option displayed on the website hosted by the server 210. As part of this process, the server 210 may provide an indication of a dietary option that has been suggested for that day. In the event that the user ate the suggested dietary option, they can simply provide confirmation of this. It will be appreciated that this reduces the data entry burden, which can in turn encourage user behaviour by making it very easy for the user to comply with the suggested dietary option. If however the user did not comply they can provide information regarding alternative foods that they ate. [0094] At step 630 a dietary compliance score is determined. It will be appreciated that the score can be calculated in any appropriate manner that would typically involve providing a defined value, such as a value on a scale of "1" to "10", depending on how well the user complied. For example if a diabetic were to eat a food high in sugar this could be used to indicate a high degree of non-compliance, with a score being assigned accordingly. Scoring could be performed on a range of factors, including overall calorie intake, as well balance of foodstuffs between different food groups. Such scoring systems will be apparent to those skilled in the art and will not therefore be described in any further detail. [0095] At step 640 the activity sensing device uploads activity data to the server 210. This can be achieved in any suitable manner but typically involves transferring activity data to the end station 203 and then forwarding this to the server 210. Again an activity compliance score is determined at step 650 with this reflecting both the degree and magnitude of compliance with defined activity criteria forming part of the user's care management program. [0096] An overall degree of compliance can then be determined based on the dietary and activity compliance scores at step 660, with this being recorded as part of the user's profile, at step 670, by the server 210. The overall compliance score can be calculated in any manner and can be a combination, such as a weighted sum of the individual activity and dietary scores, or alternatively can retain the individual scores as separate components of a compliance value.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 20 [0097] Thus, the above described process, allows a degree of compliance to be assessed on a regular basis in a quantified manner. The degree of compliance can then be used to perform further actions, such as generating recommendations to assist with future compliance as will now be described with reference to Figure 7. [0098] In this example, at step 700, existing program criteria at determined, for example by accessing these from the user profile, with a degree of compliance being examined at step 710 by the server 210. At step 720 the criteria may be updated to reflect variations in compliance that are required to ensure overall compliance over the duration of the program. For example, if the user did not perform a sufficient level of activity on one day, the activity criteria for the following day can be increased. The criteria can also be adjusted based on quantified parameters, such as the subject's weight or the like, so that compliance is tailored for the respective user. [0099] Irrespective of the above, the existing program criteria can be used to make recommendations at step 730. In this regard, the recommendations can correspond to activities or in the case of diet, recipes, which would satisfy the respective criteria. The recommendations could be selected from a database of previously defined activities and recipes, with these being selected based on their ability to meet the criteria and to provide variation on a day to day basis, whilst also meeting users' preferences, for example by selecting the recipes to avoid allergies or the like. [0100] An indication of the recommendations can then be provided to the user at step 740 for example as part of the message, or by displaying these via the webpage, for example as part of a dashboard, or the like. It will be appreciated however, that alternatively, the recommendations could be provided on case by case basis, for example on demand from a user, or alternatively, each of the users could be provided with pre-defined recommendation at the start of the care management program. Finally, the user could simply be provided with relevant information, such as examples of different exercises and recipes, allowing them to make their own assessment as to which should be performed. [0101] The manner in which messages are generated and transferred will now be described with reference to Figure 8.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 21 [0102] In this example, the server 210 typically determines that messages are to be sent at step 800. This can be performed in accordance with a schedule indicating for example that messages are to be sent at predefined times. A single schedule may be utilised for all users or alternatively, users may be able to select to have messages sent to them at specified times in accordance with their own preferences, stored in their respective profile. [0103] At step 810 the server 210 selects a next user to whom a message is to be sent, and then determines a degree of compliance for that user at step 820, utilising the compliance indicator stored as described above at step 670. [0104] A message template is then selected at step 830. The template can be selected based on a range of different factors. For example, the template could be selected based on the degree of compliance, allowing a different type of message to be displayed if the user has complied verses if they have not complied. It will be further appreciated that the template could be selected not only on recent compliance, but also on historical compliance, so that for example, in the situation of repeated non-compliance, a more forceful message could be sent, urging the user more strongly of the benefits of compliance. The template may also depend on preferences of the user, so for example, a different template could be selected if the user's messaging preference is via SMS as opposed to email. [0105] The message may also be optionally modified for the user at step 840 so that it is personalised and made relevant to their situation, for example to refer to how far through the program they have progressed, to refer to any positive outcomes that have been achieved. Recommendations may also be added at step 850, for example to suggest menu or activity options for the day. [0106] Additionally, as previously mentioned at least some of the messages are or include motivational messages designed to inspire and encourage adherence to the care management program. Examples of these messages are shown below: * Good Morning and Well Done on Reaching Day X in the programme! We are so proud of you. Keep up the good work and you will be rewarded! H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 22 * Hello there! Hope you are feeling good? Have you done your exercise today? Remember exercise is big part of managing your Diabetes. Keep it up! We believe in you. * Good Morning! Having a tough day? Hard to get motivated? Go to our website for inspiration and remember we are just a phone call away. Keep working hard and the results will be amazing. You are great! * "When the need to succeed is as bad as the need to breath, then you'll be successful" wise words from Eric Thomas. And you need to succeed as much as you need to breathe! You can manage your diabetes and improve your health! * "Obstacles are what we see when we take our eyes off the goal." (Rita Davenport) Keep positive and eyes on the price - your improved health! * "You have failed only when you quit trying. Until then, you're still in the act of progression" -Tommy Kelley. Don't stop now! You are more than halfway through the trial. The health related reward will be wonderful! * Fall seven times and stand up eight. -Japanese Proverb * Charles Sindoll once said that life is 10% what happens to me and 90% of how I react to it. Being diagnosed with T2DM is certainly difficult - but with a positive attitude and hard work you can manage it! Stick to the programme and you will improve! * People often say that motivation doesn't last. Well, neither does bathing. That's why we recommend it daily. -Zig Ziglar * There are two primary choices in life - accept conditions as they exist, or to accept responsibility for change them - Dennis Waitley [0107] It will be appreciated that this process of constructing the message could be performed substantially automatically although additionally or alternatively, messages could be constructed at least in part using manual input from an operator. Following construction of the message, the server 210 transfers the message to the user at step 860, with this being performed based on the user's preferences and using an appropriate messaging application, such as an email or SMS messaging application, as will be appreciated by persons skilled in the art.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 23 [0108] At step 870 it is determined if messages for each of the users have been completed, and if not the process returns to step 810 to select the next user otherwise the process returns to step 800 to determine when further messages should next be sent. [0109] Accordingly, it will be appreciated that the above described process allows motivational messages to be constructed and transferred to users. This can be performed substantially automatically and can also operate to provide feedback to the users helping encourage their ongoing participation. [0110] An example of the process for determining the effectiveness of the care management program will now be described with reference to Figure 9. [0111] In this example at step 900 the server 210 determines quantified parameters for a plurality of users. The quantified parameters are typically measured over the course of the care management program and are indicative of the presence, absence or degree of the condition being studied. This information can be provided to the server 210 on a regular or semi-regular basis, and this can vary depending on the implementation and parameter under consideration. For example, users could be encouraged to provide weight information or the like on a daily or weekly basis. Alternatively however, if the quantification requires medical intervention, such as determination of HbAlc levels, this would typically be performed at set time intervals, such as the beginning, middle or end of the program. [0112] At step 910 the server 210 uses the quantified parameter to determine changes in user characteristics, such as changes in weight and/or HbAlc levels over the course of the care management program. [0113] At step 920, changes in user characteristics can be used in determining recommendations and/or changes in program criteria in a manner similar to that described above with respect to Figure 7. So for example, if a user is meeting the defined criteria but is failing to meet a set goal, such as losing weight, the criteria could up adapted to increase activity requirements, or lower calorie intakes. [0114] In any event, at step 930, the server 210 reviews changes in the degree of compliance and then uses this together with changes in user characteristics to assess the effectiveness of H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 24 the care program at step 940. Thus, this process can ascertain whether users that complied with the care management program have seen any benefit and whether users that failed to comply have not seen any benefit, which in turn provides an indication of the effectiveness of the care management program for the user. It will be appreciated that this information can be used for a number of different purposes. [0115] For example, this can be used in conjunction with user details to assess the effectiveness of the care management program for a range of different demographic groups. This can also be used to assess whether the subject might benefit from alternative forms of intervention. [0116] Accordingly, the above described process provides a mechanism for motivating individuals to participate in care management programs, as well as further assessing the impact of their participation and hence the effectiveness of the program and whether further alternative interventions may be required. [0117] The above described system can be implemented utilising a modular arrangement and an example of this is shown in Figure 10. [0118] In this example user details 1000 can be received via a registration module and loaded into a user details database 1030. Activity data 1010 and diet data 1020 are received via activity sensing device and dietary modules 1015, 1025 respectively, with these being added to the user details database 1030. As part of this process, the dietary module 1025 may access a program database 1040 which stores recommended diet information so that this can be assessed against the diet received. A compliance module 1035 utilises user details and program information from the databases 1030, 1040 to assess compliance with this information being provided to a messaging module and a recommendations module to perform messaging and produce the recommendations as described above. [0119] Throughout this specification and claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers or steps but not the exclusion of any other integer or group of integers.

H:\stp\Interwoven\NRPortbl\DCC\STP\8105415_1.docx-24/10/20 11 - 25 [0120] Persons skilled in the art will appreciate that numerous variations and modifications will become apparent. All such variations and modifications which become apparent to persons skilled in the art, should be considered to fall within the spirit and scope that the invention broadly appearing before described.