WO2009103107A1 - Interactive personal portable data management system - Google Patents

Interactive personal portable data management system Download PDF

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Publication number
WO2009103107A1
WO2009103107A1 PCT/AU2009/000171 AU2009000171W WO2009103107A1 WO 2009103107 A1 WO2009103107 A1 WO 2009103107A1 AU 2009000171 W AU2009000171 W AU 2009000171W WO 2009103107 A1 WO2009103107 A1 WO 2009103107A1
Authority
WO
WIPO (PCT)
Prior art keywords
data
time
storage means
storing
communication interface
Prior art date
Application number
PCT/AU2009/000171
Other languages
French (fr)
Inventor
Cosimo Graps
Original Assignee
Inspirovate Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2008900777A external-priority patent/AU2008900777A0/en
Application filed by Inspirovate Pty Ltd filed Critical Inspirovate Pty Ltd
Publication of WO2009103107A1 publication Critical patent/WO2009103107A1/en

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Classifications

    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/10Office automation; Time management
    • G06Q10/109Time management, e.g. calendars, reminders, meetings or time accounting
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G16H10/65ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/70ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mental therapies, e.g. psychological therapy or autogenous training
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • the present invention relates to methods and portable apparatus for acquiring and storing time-series data.
  • time-series data is it may be critical to the treatment and resultant health of a patient that correct doses of medicine are taken at the appropriate times, such as after meats, and a record of the administration is kept.
  • a pedometer that counts steps.
  • Pedometers are examples of simple devices that passively count steps by the movement of a small weight or accelerometer in response to a step motion and the total of movements is recorded from a start point to an end point.
  • Energy expenditure and distance travelled for a particular individual may be calculated from simple constants for weight and distance travelled per step,
  • heart rate monitors record the heart beats from which the heart rate may be calculated for an individual-
  • US 6,234,964 and US 6,770,029 to llliff describe very complex systems for disease management.
  • the systems require a complex of computer software-hardware-communications, including a computer screen, for operation.
  • the llliff patents teach the use by a patient of a computer to communicate with a computer system platform,
  • the systems described in those documents include a disease management module which collects data interactively from a patient who enters the data using a computer keyboard on prompts from the system during a computer-based consultation.
  • the disease management module uses the interactive consultations to assist with the management of disease over time.
  • the interactive online dialogues are carried out by way of scripts, which are special computer programs that are capable of o ⁇ tp ⁇ tting text and questions to a patient, waiting for a response from the patient, recording the response, and taking further action based on the response.
  • the disease management module performs all of its contact with patients in the form of disease management sessions, which are regularly scheduled, online dialogs with the patient. Systems like those taught by llliff are not very portable and convenient for interaction by a person moving about their daily activities.
  • US 6,334,778 to Brown incorporates a video display device for interacting with a patient for diagnostic assessment of a psychological condition.
  • This invention is directed toward adapting systems like video game systems for undertaking psychological testing.
  • the system incorporates diagnosing the attention characteristics of a patient by measuring the response time of a patient to a stimulus by pressing a switch.
  • the system also incorporates dynamically programmed masks for data input.
  • time-series data customised for an individual needs to be collected at appropriate intervals and where the individual is actively involved with the data collection and analysis.
  • the data that is collected must include behavioural and qualitative observations associated with behaviour.
  • a customised treatment system based on the individual needs of a patient that incorporates a specific dosage and treatment regime and reminds and records when the treatment is taken would be very useful in determining the effectiveness of a treatment program in an efficient manner.
  • the system should be very portable, uncomplicated and easy to use. No such system currently exists as far as the inventor is aware.
  • the invention provides a method and system for active data collection that incorporates a device for collecting pre-determined data types through a simple communication interface operatively engaged with a microprocessor to collect and store data.
  • the device is capable of prompting a user to actively record data.
  • the system incorporates a plurality of data input means.
  • the data input means are switches.
  • the switches are response areas on a communication interface. More preferably the switches are inductive or capacitive coils.
  • the switches may be programmable by the incorporation of a removable or interchangeable user interface, preferably a pad incorporating different prompts.
  • the microprocessor may communicate with remote processors having data storage and analysis programs.
  • the communication interface overlays the ⁇ switches for data input.
  • the communication interface comprises of a resilient material,
  • the communication interface incorporates means for identifying the type of data and function of a data input means.
  • the system is not reliant on passive collection of physiological parameter data as is known in the prior art. Instead, the system incorporates active data input from a user according to a pre-determined data collection program.
  • the user inputs event data by simple physical interaction with the data input means of the device as prompted by the system.
  • the meaning attributable to the data collected by the system is associated with appropriate computer software pre-programmed into a microprocessor which is preferably incorporated into the device.
  • the data is recorded in a data storage means in the device for transfer to a database and analysis, such as for trends in a particular parameter(s).
  • the communication interface is conveniently removable so that a prompt associated with a switch may be changed to correspond to required data input to a computer data file for later analysis.
  • the method and system of the invention are most conveniently applicable to any situation where there is a need for the systematic collection of qualitative data that is actively input by a user.
  • the data is collected over time as a time-series.
  • Such applications include, but are not limited to, collecting data about potential subjects that may be included in a clinical trial for a candidate drug, behaviour modification techniques requiring qualitative data collection such as alleviating addictive behaviour associated w ' rth nicotine or other addictive substances, or behaviour correlation, analysis and modification associated with particular activities like weight loss.
  • the invention provides a convenient means of collecting data in a structured way as determined by prompts identified on the communication interface and data input means.
  • the data input means is a switch.
  • the communication interface may be removable to change the prompts associated with a data input means, the function of the data input means being changeable according to a computer program, The meaning for the collected data is provided by the computer program. Because the communication interface is removable and/or exchangeable, it can be made of inexpensive materials.
  • the device can be easily programmed by changing and storing a different computer program on the microprocessor and the communication interface can be provided with a different set of prompts indicated and to change the meaning of the collected data according to the new computer program.
  • the invention provides an easy, efficient, simple, and cheap way to collect data in response to prompts located on the face of the device.
  • the invention provides a tool to assist with immediate data collection, particularly time-series data, which may be used to identify trends or triggers that relate to a problem.
  • the system may include a combination of computer software with an easily operated device to provide functionality that is very flexible and may include graphical representation .of data, in addition the software may incorporate algorithms to identify behaviours associated with problems and data trends- such as behavioural trends.
  • One piece or group of data may have qualifiers tagged to it, including events which recur a particular number of times before or after a chosen event.
  • qualifiers tagged to it, including events which recur a particular number of times before or after a chosen event.
  • the invention may incorporate software designed to allow the choice of highlighting the data or group of data surrounding data or a group of data-
  • Figure 1 shows the steps for operating an interactive personal portable data management system.
  • Figure 2a shows a top perspective view of an embodiment of an interactive personal portable data management system.
  • Figure 2b shows a side exploded view of an embodiment of an interactive personal portable data management system.
  • Figure 2c shows an end perspective view of the personal portable data management system.
  • Figure 2d shows a representation of a network incorporating an interactive personal portable data management system.
  • Figure 3 shows a top perspective exploded view of the layers included in an embodiment of an interactive personal portable data management system.
  • the apparatus and method of the invention provide a simple and easy solution for the convenient and structured collection of time-series data. It will be understood that the invention can take many and * diverse embodiments according to the application in which such apparatus and methods are employed. The scope of the invention is not to be limited by the following description but is defined by the appended claims.
  • Figure 1 shows a flow chart of the steps of the method for operating a personal portable data input system according to the invention.
  • the system In a first step, the system must be activated by communicating the identifying information of a data collection device to a remote computer processor programmed to implement the data collection system.
  • a remote computer processor programmed to implement the data collection system.
  • the device's identification code is extracted and tagged to the operational program. This prevents any wrongful connection between other devices or operational programs.
  • the code also may be used to dedicate that device to a particular group or owner.
  • the computer software for the particular application is incorporated into the microprocessor of the data collection device.
  • the application can take many forms where it is important to collect time series data, preferably qualitative data.
  • Qualitative data includes data that may be, for example, a subjective assessment of feelings of well-being, a generalised range in a variable or other data that is not strictly quantitative and representing a discrete amount.
  • the computer software for the particular application is adjusted to activate response areas on the communication interface in response to input from a user when engaged, preferably by a depressive action
  • data is input by activating data input means, preferably switches, through an operatively engaged communication interface.
  • the data input is registered by activation of a switch in a response area, preferably by depressing the response area with a finger
  • data input as a result of activation is recorded in a data file on the microprocessor
  • the saved data file of raw data is transmitted to a computer for analysis by way of suitable communication means.
  • the software application is conveniently changeable and the switches or response areas may be given different functions according to the desired application.
  • the computer program may incorporate any programmed prompts which are communicated with the time and date to a computer data file, known as time-stamping.
  • FIG. 2 shows an embodiment of an interactive portable data management device and system constructed according to the invention.
  • the system includes a . data collecting device 10 shown in top perspective view in Figure 2a, exploded side perspective view in Figure 2b, and end perspective in Figure 2c.
  • the system may include remote data storage means and analysis processors.
  • Figure 2d is an embodiment of a simple network which may be used for data exchange in operating the system.
  • the device 10 comprises of members enclosed in an upper casing 18 and a lower casing 17.
  • the upper and lower casings engage by any suitable means.
  • the device 10 incorporates a microprocessor 11 capable of receiving data that is input by the user using data input means 12 operatively engaged with the microprocessor 11.
  • the data input means 12 may comprise of switches incorporated in, for example, a printed circuit board 13.
  • the switches -are inductive or capacitive coils, Data is acquired by computer software 14 stored on the microprocessor.
  • a communication interface means 15 is operatively engaged with the data input means 12.
  • An output communication means 16 may be any of a suitable connection means 27 such as an RS-232 interface, USB interface, infrared connection, optical connection or other means known in the art.
  • the output communication means 16 may communicate with a remote data storage means and analysis processors or computers 26. Power for the device is conveniently provided by a battery 19.
  • the upper portion of a casing 18 incorporates display areas 25 for viewing prompts 22 on the communication interface means 15, Preferably the device incorporates a layer or pane! of transparent material 23 for easy viewing of the communication interface means 15.
  • Including a transparent panel 23 allows the communication interface means to be made of any flexible material, if desired, the materia! being capable of having prompts printed on it or otherwise incorporated in it,
  • the prompts 22 are text prompts, but other prompts, such as icons or other signs may be used.
  • the communication interface means 15 is operatively engaged with the data input means 12 in the printed circuit board 13.
  • the communication interface means 15 overlays the printed circuit board 13.
  • the communication interface means 15 is removable and/or exchangeable.
  • the preferred arrangement of communication interface 15 having prompts 22 overlaying the data input means 12 very conveniently allows a user to input data into the microprocessor when prompted.
  • the device 10 incorporates a plurality of data input means 12 such as switches, preferably inductive or capacitive coils, for active data input by the user.
  • the data input means 12 are activated by the user engaging response areas 21 on the communication interface means 15.
  • Operating the data input means 12 in the response areas 21 of the device may be accomplished with a small force, such as delivered by pressing, and engaging the data input means 12 to cause an electrical signal to be registered, as with a switch.
  • the activation of a switch may occur through engaging by depressing the response area, or some other communications means such as inductance or heat sensitivity.
  • a response area may engage more than one switch.
  • Figure 3 shows an embodiment in which there are a number of response areas overlaying data input means 12, four of which interoperate with two switches each. Other response areas activate switches for cancelling data input 29» delaying data input 30, or entering or accepting data input 31, for example.
  • the system incorporates four data input means. All switches may not be functional at all times. One, two or three switches may only be required, depending on the application. The secondary level on each response area may also be limited to none, one, two or three switches. It will be understood that other embodiments with different numbers of switches are within the scope of the invention, In all of these cases the device (when programmed that way) will only indicate active options,
  • the communication interface means 15 operates to direct the user which data input means 12 to operate at any particular time by way of response areas 21 identifying data input prompts 22.
  • the most advantageously removable and/or exchangeable communication interface 15 may aiso incorporate a clear envelope that allows a card to be slotted in.
  • the invention includes a very compact and portable device 10.
  • the embodiments shown in Figures 2 and 3 are preferably about 70 mm long, 45 mm wide, and 10 mm deep. However, other dimensions may be suitable for particular applications.
  • a device 10 may incorporate a display that shows time and date (not shown), Light Emitting Diodes (LEDs) 32, alarm means such as a buzzer (not shown), and key lock means.
  • the LEDs 32 conveniently indicate the status of a response area 21.
  • Data input means operatively engaged with response areas are used to record events of interest and an attribute of an event, such as its degree of severity.
  • Each response area in the embodiments shown herein has two related LEDs 32 which preferably show two different colours. Preferably one LED is red and one is green. The LEDs are used to indicate that the user has engaged the response area to activate the data input means and data has been input to the microprocessor.
  • the device 10 may include a "cancel" response area 29. This area is used to remove unwanted selections or cancel unwanted prompts. There is one LED, • preferably coloured red, associated with this response area. The LED is used to indicate a prompt cancel is available or that the selection can be cancelled.
  • the device 10 may include an "enter" response area 31. This response area is used to confirm the entry of data into the database or to indicate that a prompt has been completed. There is an LED, preferably green, associated with this response area. The LED is used to indicate a prompt completion is available or that the selection can be entered and stored.
  • the device 10 may include a "delay" response area 30. This response area is used to delay a prompt from prompting data input. There is one LED, preferably amber, associated with this response area. This LED indicates that a prompt has occurred and needs to be addressed.
  • the device 10 may include an alarm to audibly confirm when a prompt occurs (not shown).
  • the alarm is a buzzer that chimes with variable pulses.
  • Such an alarm enables more than one prompt to be programmed and each has a different chime.
  • the device incorporates a key lock switch 20, for preventing false activation of any selections or recognition of any prompts,
  • the communication means 16 preferably a USB connector, provides the device 10 with the connection required to transfer data to and from a database 28 stored on a remote computer 26, preferably a personal computer that has the program on it.
  • the system may include different types of data inputting signalling means.
  • the relative response area is pressed, which illuminates the response area's signalling means, preferably an LED, preferably a red colour, If there is a secondary level (severity/level) then the LEDs or another colour, preferably green, that are associated to response areas blink to show the availability of the secondary level.
  • the green LED remains lit. At this stage there will be one red and one green LED lit. At this time the red “cancel” LED illuminates and the green "enter” LED illuminates.
  • the enter response area is pressed. If the combination Is incorrect, the cancel response area is pressed. If the enter response area is pressed the combination, time and date is stored and available for upload. If the cancel response area is pressed, the selected combination is cleared. This process can be repeated many times without uploading the data.
  • the key lock switch prevents any unwanted response area presses. To accept any response area press the switch has to be on the off position. To prevent any key press the switch has to be on the on position.
  • the device 10 When data is to be uploaded, the device 10 is in communication with a processing device, such as a computer 26, preferably a PC or laptop computer, The device then synchronises with the software and data from the device 10 is automatically uploaded. Clearing the data is optional. If the operational program has altered it automatically downloads the changes. The date and time is then checked and if different the user is prompted to accept an update. •
  • a processing device such as a computer 26, preferably a PC or laptop computer
  • the communication interface 15 provides a very simple, quick, easy, and cheap way of providing and changing meaning to data that is input to the device by a user.
  • the activation of a switch in a response area is given meaning by a computer program.
  • the meaning associated with particular switch is printed on the communication interface.
  • Engaging a response area 21 on the communication interface 15 and thereby operating the underlying data input means 12 indicates a positive response to the particular prompt associated with the computer software.
  • Response areas 21 may be assigned permanent or floating functions in the computer program that accepts data from the data input means 12. Permanent functions include data entry, cancellations, or prompt delay. Floating functions are programmable according to the type and structure of data to be acquired.
  • the software may be incorporated in the device 10 or it may be located on a server 24 as an internet-based 33 program.
  • the data collected by the user using the device 10 is transmitted 34 to and held in a data file on a central database 28 located on a remote server.
  • the system is capable of collecting data for trend analysis in the variables which are represented by the programmable response areas,
  • non-volatiie constant, volatile constant, controlled event and uncontrolled event as described in the following non-limiting examples, which illustrate the surprising simplicity but versatility of the system, which make it easy and cheap to manufacture as well as cheap and easy to use.
  • Particular constants may include variable such as GPS data, blood pressure, heart rate, body temperature, ambient temperature, weather for example. Examples of types of data collected are;
  • Non-volatile constant time, date, season, blood type, hair colour, etc.
  • Volatile constant - weather, temperature, diet, blood pressure, body temperature, etc
  • Controlled event diet choice, medication, exercise, alcohol, eye correction, etc
  • Uncontrolled event pain, diarrhoea, sickness, addiction fix, allergic reaction, etc
  • Ail non-volatile and some volatile data can be added at any time.
  • a controlled event is a planned event and an uncontrolled event is usually a symptom or the target problem.
  • An important aspect of keeping data is whether or not the device is properiy functioning.
  • the device incorporates a time-keeping member in the device.
  • the time-keeping member communicates the time through a time screen. A user may determine that the device is in a functional state by quickly viewing the time screen.
  • central database 28 allows for the owner to access the software and data from any location. It also allows for the end users to upload data without the owner's presence or assistance. The end user does not have access to the data or software functions. The data then is only stored and waiting for the owners approval. Holding the data on an online database does not mean that the data has to be shared with other owners.
  • Access to the software and database that is available more than one user should only be available to qualified users. That would be a professional who either creates live programs or uses existing available programs designed by other professionals. Unqualified users do have access to the software, but is limited to programming only the one purchased device.
  • Name- this is the name that identifies the response area
  • Secondary level- yes or no this indicates the severity of the event Secondary level 1- Level identifier, it is recommended that the level identifiers have constant identifiers for all response areas. This makes the labelling more practical, unless a display model is used. All levels do not have to be used.
  • Some advanced options could include functions like a time filter- that stops the response areas recording more than one event in a given time frame,
  • the response area is where the prompt(s) are programmed.
  • the prompts can be static or active.
  • a static prompt is pre-programmed and non-volatile,
  • An active prompt can be preprogrammed and subject to set conditions or not pre-programmed and subject to set conditions. That means that an active prompt is dependant on set criteria.
  • the response area can be tagged as
  • Prompt time- time prompt is active Repetition- every hour, day, week, month
  • Active condition - responds to Response area 1, 2, 3 or 4 or has an AND function or an OR function. This can also have time in-between or within etc.
  • Active alteration- this asks if the original program changes with conditions or remains in place regardless of conditions.
  • Advanced options could include things like LED blink type or buzzer tone type.
  • More than one prompt can be programmed.
  • the delay response area can sirnpiy be programmed to implement a predetermined delay of a prompt. That delay can have conditions where every time it is pressed the reactivate time is either extended or reduced.

Abstract

The present invention provides personal portable apparatus and methods for inputting and storing data, preferably qualitative time-series data, such as data associated with administering medication, smoking, exercising, diet, or disease management. The invention includes a device activated to accept data though an input means, data storage means for storing collected data in a data file on a microprocessor incorporating a computer program for identifying the data type, and a conveniently removable communication interface incorporating at least one data input prompt wherein engagement of a prompt area on the removable communication inputs data into the data storage means. Data is input preferably through switches which may be electric inductive or capacitive coils. The prompts on the removable communication interface and the meaning associated with the collected data may be changed with the application simply by reprogramming the microprocessor. The apparatus may be part of a network system with multiple users.

Description

Title
Interactive Personal Portable Data Management System
Field of the Invention The present invention relates to methods and portable apparatus for acquiring and storing time-series data.
Background
There are many situations in which repeated tasks and data collection for analysis are needed. One example is the passive collection of monitored physiological data, including time-series data acquired by sensors from patients, where the data is collected automatically by a system incorporating sensors and the output of sensors is stored or transmitted for analysis, Another example is where medicines need to be administered at regular intervals and associated physiological data must be collected at the lime. Often the data collected is quantitative. However, there is also a need to collect qualitative data over time.
One example of a need for collecting time-series data is it may be critical to the treatment and resultant health of a patient that correct doses of medicine are taken at the appropriate times, such as after meats, and a record of the administration is kept. In another example of collecting time-series data as with a pedometer that counts steps. Pedometers are examples of simple devices that passively count steps by the movement of a small weight or accelerometer in response to a step motion and the total of movements is recorded from a start point to an end point. Energy expenditure and distance travelled for a particular individual may be calculated from simple constants for weight and distance travelled per step, In a further example, heart rate monitors record the heart beats from which the heart rate may be calculated for an individual- Some systems include rudimentary computer software for storage of data and display on a computer screen.
There are some systems known for certain complicated applications like disease management. For example, US 6,234,964 and US 6,770,029 to llliff, describe very complex systems for disease management. The systems require a complex of computer software-hardware-communications, including a computer screen, for operation. The llliff patents teach the use by a patient of a computer to communicate with a computer system platform, The systems described in those documents include a disease management module which collects data interactively from a patient who enters the data using a computer keyboard on prompts from the system during a computer-based consultation. The disease management module uses the interactive consultations to assist with the management of disease over time. The interactive online dialogues are carried out by way of scripts, which are special computer programs that are capable of oυtpυtting text and questions to a patient, waiting for a response from the patient, recording the response, and taking further action based on the response. The disease management module performs all of its contact with patients in the form of disease management sessions, which are regularly scheduled, online dialogs with the patient. Systems like those taught by llliff are not very portable and convenient for interaction by a person moving about their daily activities.
Similarly, US 6,334,778 to Brown incorporates a video display device for interacting with a patient for diagnostic assessment of a psychological condition. This invention is directed toward adapting systems like video game systems for undertaking psychological testing. The system incorporates diagnosing the attention characteristics of a patient by measuring the response time of a patient to a stimulus by pressing a switch. The system also incorporates dynamically programmed masks for data input.
There are many situations where time-series data customised for an individual needs to be collected at appropriate intervals and where the individual is actively involved with the data collection and analysis. The data that is collected must include behavioural and qualitative observations associated with behaviour. For example, a customised treatment system based on the individual needs of a patient that incorporates a specific dosage and treatment regime and reminds and records when the treatment is taken would be very useful in determining the effectiveness of a treatment program in an efficient manner. Further, the system should be very portable, uncomplicated and easy to use. No such system currently exists as far as the inventor is aware.
Summary of the Invention
The invention provides a method and system for active data collection that incorporates a device for collecting pre-determined data types through a simple communication interface operatively engaged with a microprocessor to collect and store data. Preferably the device is capable of prompting a user to actively record data. The system incorporates a plurality of data input means. Preferably the data input means are switches. Preferably the switches are response areas on a communication interface. More preferably the switches are inductive or capacitive coils. The switches may be programmable by the incorporation of a removable or interchangeable user interface, preferably a pad incorporating different prompts. The microprocessor may communicate with remote processors having data storage and analysis programs. Most advantageously, the communication interface overlays the switches for data input. Preferably the communication interface comprises of a resilient material, The communication interface incorporates means for identifying the type of data and function of a data input means.
The system is not reliant on passive collection of physiological parameter data as is known in the prior art. Instead, the system incorporates active data input from a user according to a pre-determined data collection program. The user inputs event data by simple physical interaction with the data input means of the device as prompted by the system. The meaning attributable to the data collected by the system is associated with appropriate computer software pre-programmed into a microprocessor which is preferably incorporated into the device. The data is recorded in a data storage means in the device for transfer to a database and analysis, such as for trends in a particular parameter(s). The communication interface is conveniently removable so that a prompt associated with a switch may be changed to correspond to required data input to a computer data file for later analysis.
The method and system of the invention are most conveniently applicable to any situation where there is a need for the systematic collection of qualitative data that is actively input by a user. Preferably the data is collected over time as a time-series.
Such applications include, but are not limited to, collecting data about potential subjects that may be included in a clinical trial for a candidate drug, behaviour modification techniques requiring qualitative data collection such as alleviating addictive behaviour associated w'rth nicotine or other addictive substances, or behaviour correlation, analysis and modification associated with particular activities like weight loss.
The invention provides a convenient means of collecting data in a structured way as determined by prompts identified on the communication interface and data input means. Preferably the data input means is a switch. Most advantageously, the communication interface may be removable to change the prompts associated with a data input means, the function of the data input means being changeable according to a computer program, The meaning for the collected data is provided by the computer program. Because the communication interface is removable and/or exchangeable, it can be made of inexpensive materials. The device can be easily programmed by changing and storing a different computer program on the microprocessor and the communication interface can be provided with a different set of prompts indicated and to change the meaning of the collected data according to the new computer program. The invention provides an easy, efficient, simple, and cheap way to collect data in response to prompts located on the face of the device. In operation, the invention provides a tool to assist with immediate data collection, particularly time-series data, which may be used to identify trends or triggers that relate to a problem.
The system may include a combination of computer software with an easily operated device to provide functionality that is very flexible and may include graphical representation .of data, in addition the software may incorporate algorithms to identify behaviours associated with problems and data trends- such as behavioural trends. One piece or group of data may have qualifiers tagged to it, including events which recur a particular number of times before or after a chosen event. There are many possible combinations of data types and programs within the scope of the invention. The invention may incorporate software designed to allow the choice of highlighting the data or group of data surrounding data or a group of data-
Brief Description of the Figures
Figure 1 shows the steps for operating an interactive personal portable data management system.
Figure 2a shows a top perspective view of an embodiment of an interactive personal portable data management system.
Figure 2b shows a side exploded view of an embodiment of an interactive personal portable data management system.
Figure 2c shows an end perspective view of the personal portable data management system. Figure 2d shows a representation of a network incorporating an interactive personal portable data management system.
Figure 3 shows a top perspective exploded view of the layers included in an embodiment of an interactive personal portable data management system.
Detailed Description of the Figures and Preferred Embodiments
The apparatus and method of the invention provide a simple and easy solution for the convenient and structured collection of time-series data. It will be understood that the invention can take many and* diverse embodiments according to the application in which such apparatus and methods are employed. The scope of the invention is not to be limited by the following description but is defined by the appended claims.
Figure 1 shows a flow chart of the steps of the method for operating a personal portable data input system according to the invention.
In a first step, the system must be activated by communicating the identifying information of a data collection device to a remote computer processor programmed to implement the data collection system. When synchronised with the software program the device's identification code is extracted and tagged to the operational program. This prevents any wrongful connection between other devices or operational programs. The code also may be used to dedicate that device to a particular group or owner.
In a second step, the computer software for the particular application is incorporated into the microprocessor of the data collection device. The application can take many forms where it is important to collect time series data, preferably qualitative data. Qualitative data includes data that may be, for example, a subjective assessment of feelings of well-being, a generalised range in a variable or other data that is not strictly quantitative and representing a discrete amount.
In a third step, the computer software for the particular application is adjusted to activate response areas on the communication interface in response to input from a user when engaged, preferably by a depressive action, In a fourth step data is input by activating data input means, preferably switches, through an operatively engaged communication interface. The data input is registered by activation of a switch in a response area, preferably by depressing the response area with a finger, in a fifth step, data input as a result of activation is recorded in a data file on the microprocessor, In a sixth step, the saved data file of raw data is transmitted to a computer for analysis by way of suitable communication means. The software application is conveniently changeable and the switches or response areas may be given different functions according to the desired application. The computer program may incorporate any programmed prompts which are communicated with the time and date to a computer data file, known as time-stamping.
Figure 2 shows an embodiment of an interactive portable data management device and system constructed according to the invention.
The system includes a . data collecting device 10 shown in top perspective view in Figure 2a, exploded side perspective view in Figure 2b, and end perspective in Figure 2c. The system may include remote data storage means and analysis processors. Figure 2d is an embodiment of a simple network which may be used for data exchange in operating the system.
The device 10 comprises of members enclosed in an upper casing 18 and a lower casing 17. The upper and lower casings engage by any suitable means. The device 10 incorporates a microprocessor 11 capable of receiving data that is input by the user using data input means 12 operatively engaged with the microprocessor 11. The data input means 12 may comprise of switches incorporated in, for example, a printed circuit board 13. Preferably, the switches -are inductive or capacitive coils, Data is acquired by computer software 14 stored on the microprocessor. A communication interface means 15 is operatively engaged with the data input means 12. An output communication means 16 may be any of a suitable connection means 27 such as an RS-232 interface, USB interface, infrared connection, optical connection or other means known in the art. The output communication means 16 may communicate with a remote data storage means and analysis processors or computers 26. Power for the device is conveniently provided by a battery 19. The upper portion of a casing 18 incorporates display areas 25 for viewing prompts 22 on the communication interface means 15, Preferably the device incorporates a layer or pane! of transparent material 23 for easy viewing of the communication interface means 15. Including a transparent panel 23 allows the communication interface means to be made of any flexible material, if desired, the materia! being capable of having prompts printed on it or otherwise incorporated in it, Preferably the prompts 22 are text prompts, but other prompts, such as icons or other signs may be used.
The communication interface means 15 is operatively engaged with the data input means 12 in the printed circuit board 13. Preferably the communication interface means 15 overlays the printed circuit board 13. Preferably the communication interface means 15 is removable and/or exchangeable.
The preferred arrangement of communication interface 15 having prompts 22 overlaying the data input means 12 very conveniently allows a user to input data into the microprocessor when prompted. The device 10 incorporates a plurality of data input means 12 such as switches, preferably inductive or capacitive coils, for active data input by the user. The data input means 12 are activated by the user engaging response areas 21 on the communication interface means 15.
Operating the data input means 12 in the response areas 21 of the device may be accomplished with a small force, such as delivered by pressing, and engaging the data input means 12 to cause an electrical signal to be registered, as with a switch. The activation of a switch may occur through engaging by depressing the response area, or some other communications means such as inductance or heat sensitivity. A response area may engage more than one switch.
Figure 3 shows an embodiment in which there are a number of response areas overlaying data input means 12, four of which interoperate with two switches each. Other response areas activate switches for cancelling data input 29» delaying data input 30, or entering or accepting data input 31, for example. Preferably, the system incorporates four data input means. All switches may not be functional at all times. One, two or three switches may only be required, depending on the application. The secondary level on each response area may also be limited to none, one, two or three switches. It will be understood that other embodiments with different numbers of switches are within the scope of the invention, In all of these cases the device (when programmed that way) will only indicate active options,
The communication interface means 15 operates to direct the user which data input means 12 to operate at any particular time by way of response areas 21 identifying data input prompts 22. The most advantageously removable and/or exchangeable communication interface 15 may aiso incorporate a clear envelope that allows a card to be slotted in.
The invention includes a very compact and portable device 10. The embodiments shown in Figures 2 and 3 are preferably about 70 mm long, 45 mm wide, and 10 mm deep. However, other dimensions may be suitable for particular applications.
A device 10 may incorporate a display that shows time and date (not shown), Light Emitting Diodes (LEDs) 32, alarm means such as a buzzer (not shown), and key lock means. The LEDs 32 conveniently indicate the status of a response area 21.
Data input means operatively engaged with response areas are used to record events of interest and an attribute of an event, such as its degree of severity. Each response area in the embodiments shown herein has two related LEDs 32 which preferably show two different colours. Preferably one LED is red and one is green. The LEDs are used to indicate that the user has engaged the response area to activate the data input means and data has been input to the microprocessor.
The device 10 may include a "cancel" response area 29. This area is used to remove unwanted selections or cancel unwanted prompts. There is one LED, preferably coloured red, associated with this response area. The LED is used to indicate a prompt cancel is available or that the selection can be cancelled.
The device 10 may include an "enter" response area 31. This response area is used to confirm the entry of data into the database or to indicate that a prompt has been completed. There is an LED, preferably green, associated with this response area. The LED is used to indicate a prompt completion is available or that the selection can be entered and stored.
The device 10 may include a "delay" response area 30. This response area is used to delay a prompt from prompting data input. There is one LED, preferably amber, associated with this response area. This LED indicates that a prompt has occurred and needs to be addressed.
The device 10 may include an alarm to audibly confirm when a prompt occurs (not shown). Preferably, the alarm is a buzzer that chimes with variable pulses. Such an alarm enables more than one prompt to be programmed and each has a different chime. Preferably, there are different tones for each button that is pressed.
Preferably, the device incorporates a key lock switch 20, for preventing false activation of any selections or recognition of any prompts,
The communication means 16, preferably a USB connector, provides the device 10 with the connection required to transfer data to and from a database 28 stored on a remote computer 26, preferably a personal computer that has the program on it.
The system may include different types of data inputting signalling means. When events occur the relative response area is pressed, which illuminates the response area's signalling means, preferably an LED, preferably a red colour, If there is a secondary level (severity/level) then the LEDs or another colour, preferably green, that are associated to response areas blink to show the availability of the secondary level. When a level is selected the green LED remains lit. At this stage there will be one red and one green LED lit. At this time the red "cancel" LED illuminates and the green "enter" LED illuminates. If the selection combination is correct, the enter response area is pressed. If the combination Is incorrect, the cancel response area is pressed. If the enter response area is pressed the combination, time and date is stored and available for upload. If the cancel response area is pressed, the selected combination is cleared. This process can be repeated many times without uploading the data.
The key lock switch prevents any unwanted response area presses. To accept any response area press the switch has to be on the off position. To prevent any key press the switch has to be on the on position.
When data is to be uploaded, the device 10 is in communication with a processing device, such as a computer 26, preferably a PC or laptop computer, The device then synchronises with the software and data from the device 10 is automatically uploaded. Clearing the data is optional. If the operational program has altered it automatically downloads the changes. The date and time is then checked and if different the user is prompted to accept an update. •
The communication interface 15 provides a very simple, quick, easy, and cheap way of providing and changing meaning to data that is input to the device by a user. The activation of a switch in a response area is given meaning by a computer program. For any particular application. the meaning associated with particular switch is printed on the communication interface. Engaging a response area 21 on the communication interface 15 and thereby operating the underlying data input means 12 indicates a positive response to the particular prompt associated with the computer software. Response areas 21 may be assigned permanent or floating functions in the computer program that accepts data from the data input means 12. Permanent functions include data entry, cancellations, or prompt delay. Floating functions are programmable according to the type and structure of data to be acquired.
The software may be incorporated in the device 10 or it may be located on a server 24 as an internet-based 33 program. Preferably the data collected by the user using the device 10 is transmitted 34 to and held in a data file on a central database 28 located on a remote server.
The system is capable of collecting data for trend analysis in the variables which are represented by the programmable response areas,
In one embodiment, there are four main parts of data, being non-volatiie constant, volatile constant, controlled event and uncontrolled event as described in the following non-limiting examples, which illustrate the surprising simplicity but versatility of the system, which make it easy and cheap to manufacture as well as cheap and easy to use. Particular constants may include variable such as GPS data, blood pressure, heart rate, body temperature, ambient temperature, weather for example. Examples of types of data collected are;
Non-volatile constant = time, date, season, blood type, hair colour, etc. Volatile constant - weather, temperature, diet, blood pressure, body temperature, etc Controlled event = diet choice, medication, exercise, alcohol, eye correction, etc Uncontrolled event = pain, diarrhoea, sickness, addiction fix, allergic reaction, etc
Ail non-volatile and some volatile data can be added at any time. A controlled event is a planned event and an uncontrolled event is usually a symptom or the target problem. An important aspect of keeping data is whether or not the device is properiy functioning. Preferably, the device incorporates a time-keeping member in the device. Preferably, the time-keeping member communicates the time through a time screen. A user may determine that the device is in a functional state by quickly viewing the time screen.
The use of a central database 28 allows for the owner to access the software and data from any location. It also allows for the end users to upload data without the owner's presence or assistance. The end user does not have access to the data or software functions. The data then is only stored and waiting for the owners approval. Holding the data on an online database does not mean that the data has to be shared with other owners.
Access to the software and database that is available more than one user should only be available to qualified users. That would be a professional who either creates live programs or uses existing available programs designed by other professionals. Unqualified users do have access to the software, but is limited to programming only the one purchased device.
Example of Operation of the System '
Name- this is the name that identifies the response area
Data type- controlled event, uncontrolled event and some volatile constants.
Secondary level- yes or no, this indicates the severity of the event Secondary level 1- Level identifier, it is recommended that the level identifiers have constant identifiers for all response areas. This makes the labelling more practical, unless a display model is used. All levels do not have to be used.
Secondary level Z- as above
Secondary level 3- as above Secondary level 4- as above
Some advanced options could include functions like a time filter- that stops the response areas recording more than one event in a given time frame,
The response area is where the prompt(s) are programmed. The prompts can be static or active. A static prompt is pre-programmed and non-volatile, An active prompt can be preprogrammed and subject to set conditions or not pre-programmed and subject to set conditions. That means that an active prompt is dependant on set criteria.
The response area can be tagged as
Name- this is the name that identifies the prompt
Prompt type- static or active
Prompt time- time prompt is active Repetition- every hour, day, week, month
Active condition - responds to Response area 1, 2, 3 or 4 or has an AND function or an OR function. This can also have time in-between or within etc.
Active alteration- this asks if the original program changes with conditions or remains in place regardless of conditions. Advanced options could include things like LED blink type or buzzer tone type.
More than one prompt can be programmed.
The delay response area can sirnpiy be programmed to implement a predetermined delay of a prompt. That delay can have conditions where every time it is pressed the reactivate time is either extended or reduced.

Claims

Claims
1. Portable apparatus for inputting and storing data, comprising: a housing; data input means; a data storage means for storing data in a data file; microprocessor incorporating a computer program for identifying the data type; removable communication interface incorporating at least one data input prompt; wherein engagement of a prompt area on the removable communication inputs data into the data storage means.
2. The apparatus of claim 1 wherein the data input means is a switch
3. The apparatus of claim 2 wherein the removable communication interface comprises of resilient material, 4. The apparatus of claim 1 further comprising communication means for communicating data in the data file to a separate data storage means.
5, The apparatus of claim 1 wherein the data storage means is a flash memory card.
6. The apparatus of claim 1 further comprising of signalling means. 7. The apparatus of claim 6 wherein the signalling means is an LED.
8. The apparatus of claim 4 wherein the communication means is a fixed connection.
9. The apparatus of claim 1 further comprising means to cancel data input.
10. Apparatus for inputting and storing data, comprising: a housing; data input means for inputting data; data storage means for storing data in a data file; computer program for identifying the data type associated with a data input means; and removable communication interface having at least one response area identified as a data input prompt identifiable on a first side and at least one data input means engagement area on a second side; wherein engagement of the prompt area on the communication interface activates a data input means to input data into the data file, 11. The apparatus of ciaim 1 further comprising communication means for communicating data in the data file to a separate data storage means.
12. Apparatus of claim 10 further wherein the data input means is an inductive or capacitive coil switch.
13. Method for acquiring and storing qualitative time-series data comprising the steps of: activating a data storage means to receive unique data; installing a computer program on said data storage means to receive unique time-series data; signalling a user to input data according to said installed computer program; inputting time-series data into a computer data file in response to a variable prompt defined by said computer program at a first time with a time identifier at said first time; and repeating the preceding step at a second and later times,
14. Method according to claim 13 wherein the signal is either visual or aural;
16. A method for acquiring and storing data comprising the steps of: activating a data collection device for data collection; transmitting computer software for data collecting to the device; programming data input means to receive data according to prompts; inputting data in response to programmed prompts; and storing time series data in a data file. 16, The method of claim 13 where the data is time-series data.
17. The method of claim 14 where the data is data related to a user's physiology.
18. The method of claim 14 where the data is related to a user's food intake.
19. The method of claim 14 where the data is related to the administration of drugs,
20. The method of claim 14 where the data is related to the user's perception of well-being.
21. A system incorporating a plurality of apparatus according to claim 1 further comprising a microprocessor programmed with a database to accept data from a plurality of users.
22. Apparatus for inputting and storing data substantially as herein described with reference to the figures.
PCT/AU2009/000171 2008-02-18 2009-02-17 Interactive personal portable data management system WO2009103107A1 (en)

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AU2008900777A AU2008900777A0 (en) 2008-02-18 Interactive Personal Portable Data Management System

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