US 8,554,802 B1Grant

System to dynamically collect and synchronize data with mobile devices

Issue Date:2013-10-08

•29 Claims

•9 Drawing Sheets

Abstract

The invention enables bi-directional mobile communication by researchers, clinicians or counselors with their patients and study participants. An exemplary application is ecological momentary assessment of psychological and physical status related to weight management. The system may be combined with objective information to trigger a communication and enhance responses assessed on food choices, dietary intake, physical activity, exertion, mood and companions.

Metadata

Assignee

MEI Research, Ltd.

Inventors

Charles Barden
Jon Moon
Jared D Sieling

Application Information

Application Number:US 13/269,611

Filing Date:2011-10-09

Priority Date:2010-10-09

Art Unit:2166

Classifications

IPC:

G06F7/00

Patent Drawings (9 sheets)

Description

CROSS-REFERENCE TO RELATED PATENT DOCUMENT

[0001] This patent application claims the benefit of priority, under 35 U.S.C. Section 119(e), to Charles Barden U.S. Provisional Patent Application Ser. No. 61/391,591, entitled “System to Dynamically Collect and Synchronize Data with Mobile Devices”, filed on Oct. 9, 2010.

FIELD OF THE INVENTION

[0002] This invention relates to software, communications and methods to assess energy balance; obtain context information on actions and environment; and support individuals, their clinicians or other practitioners to promote a healthy lifestyle by managing weight, diet, addiction and other behaviors. More specifically, the invention can be used to collect information and responses on food choices and intake, activity diaries, ratings of exertion, mood, companions and other input sought by researchers, clinicians, advisers or counselors.

BACKGROUND OF THE INVENTION

[0003] The weight status of Americans has been declared a serious public health problem and is already burdening our health care systems. Obesity and low physical activity are prime risks for multiple forms of morbidity and mortality including several chronic diseases (coronary heart disease, Type II Diabetes, arthritis, sleep apnea and some forms of cancer). Obesity and overweight are a result of energy imbalance—excess macronutrient intake and low levels of physical activity.

[0004] Unfortunately, past approaches to weight loss treatments have proven ineffective for both children and adults, despite increasing awareness and individual efforts to lose weight. Traditionally effective treatments for overweight individuals need to be intensive enough to cause a change in lifestyle. Techniques to deliver such treatments would overwhelm our healthcare system. Programs also need to reach people with limited finances and who live in locations remote from experienced professionals and clinics. Further, feedback and other support for patients must be adapted to their daily lives and as concurrently as possible with behavior that should be altered.

[0005] An exemplary use of the invention is ecological momentary assessment (EMA). EMA is a timely record of actions and environment that preserves immediate psychological and physical status. EMA replaces recall diaries to overcome bias and errors from delayed records. Simple examples of EMA might have a study participant provide a rating of perceived exertion (RPE) after an exercise session or assign a score from a Likert scale to their present mood. Electronic EMA (eEMA) methods are a further improvement that replace paper surveys and increase privacy. EMA has become a popular tool to collect data and influence behavior change. EMA allows researchers and clinicians to obtain behavioral, social context, and individual cognition in near real time. eEMA has been demonstrated as superior to other methods, especially paper, for avoiding recall bias.

[0006] Rofey, et al [“Utilizing Ecological Momentary Assessment in pediatric obesity to quantify behavior, emotion, and sleep”, Obesity 18(6):1270-1272, 2010] stated that, “ . . . technological devices that gather objective data have reasonably high compliance rates, and may inform measurement of treatment outcomes in adolescents who are obese”. Mobile devices, especially “smartphones” can enhance eEMA with objective measures made by sensors such as time, location, speed, acceleration, temperature, light level, and proximity to locations of interest or electronic devices (including other smartphones) carried by people with a relation to a participant. These additional objective measures can be attached to a particular instance of eEMA (such as a Survey) to provide context. Or, the sensor measurements can be made continuously and the eEMA coordinated with the concurrent record.

[0007] There are indications that interventions for weight management, addictive and other deleterious behaviors can provide sustained effectiveness. Multiple factors and behaviors need to be targeted together with timely, personally tailored interventions supported by actionable information. The interventions need to be maintained outside of clinic or group settings and respond to the changing needs of participants. Individualized interventions on multiple behaviors are most important with individuals who are refractory managing their weight (US Dept of Health and Human Services reports). With their rich User Interface and increasingly capable processors smartphones are able to not only gather eEMA information enhanced with objective context they can also bring immediately useful information back to participants in studies or clinical treatments.

[0008] The invention could be used in any situation in which a person or entity wishes to collect data from and on individuals who have agreed to provide that data. For example, this invention could be used by market researchers wishing to collect data from potential users of a new product.

OBJECTS OF THE INVENTION

[0009] This invention allows a Researcher, to:

- [0010] create and modify Surveys and Items for individual Participants or groups of Participants;
- [0011] create Prompts and Annunciations that can be independent or associated with the Surveys;
- [0012] associate the Annunciations and presentation of the Items with Triggers related to predetermined conditions;
- [0013] deploy the Surveys to Participant Devices;
- [0014] present the Surveys to the Participants on demand or in response to Triggers and gather Participant Responses;
- [0015] gather, organize and attach context to Prompts and Participant Responses;
- [0016] return the Participant Responses to a remote Server or database;
- [0017] organize and store the Participant Responses and present them to the Researcher and/or Participant or to predetermined algorithms for automated actions.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a block diagram of the system components and flow of information.

[0019] FIG. 2 is a flow diagram showing the steps in the process to create and deploy a Data Request to a Participant Device; collect, store and upload data to a central Server Database; and extract, view and analyze the collected data.

[0020] FIG. 3 is an example of a web page to create annunciations, triggers or prompts.

[0021] FIG. 4 is an example of a web designer form to create Survey questions.

[0022] FIG. 5 is an entity relationship diagram of the Server Database tables and their relationship to each other.

[0023] FIG. 6 is an example of a Survey presentation on a Participant Device.

[0024] FIG. 7 is an example of a Survey question with the branching option.

[0025] FIG. 8 is a summary view of the dynamic Survey/Trigger system.

GLOSSARY

[0026] Researcher—an investigator, clinician, other person or entity desiring to collect information from or interact with one or more Participants.
[0027] Participant—a patient or other person, often enrolled in a research study, with whom a Researcher wishes to interact to provide and gather information. Participant Device—computing device, typically having a display with touch or keyboard input, such as a personal computer or mobile device (e.g., smartphone or personal digital assistant).
[0028] App or Application—software program automatically performing singular or multiple related tasks.
[0029] Server—a computer, or assemblage of computers, that link other computers or electronic devices together, providing services across a network such as the internet.
[0030] Web Server—a computer program running on a server that delivers (serves) and receives content over the internet.
[0031] Database Server—a computer program that provides database services to other computing devices, such as personal computers or Participant Devices.
[0032] Data Request—request for data from an application operating on a device separate from the device receiving the request.
[0033] Survey—a data request or other assemblage of one or more Items to be presented according to metadata and other characteristics on a Participant Device
[0034] Item—a Prompt, and associated answers if the Prompt is in the form of a question, presented to a Participant as part of a Survey
[0035] User Interface—a part of an Application that controls a display for a Researcher or the Participant that allows the Researcher or Participant to interact with the system
[0036] Metadata—data that provides context or additional information about other data and/or its means of presentation.
[0037] php script—a web-based Application that is executed by a Web Server
[0038] XML—extensible markup language is a set of rules for encoding documents electronically
[0039] Transport file—a structured file, such as XML or Json, containing one or more Surveys to facilitate download to a Participant device.
[0040] Download—the transfer of a Transport file or other data from a Server to a Participant device
[0041] Upload—the transfer of Survey information and other data from a Participant device to a Server
[0042] PDA—personal digital assistant
[0043] Compile—the process of creating an Application from source code
[0044] Json—javascript object notation is a format for encoding data or code electronically
[0045] AJAX—asynchronous javascript with XML is a method to create client based interactive web applications
[0046] Buddy Box—a radio transponder to notify a Participant Device it is at a specific location.
[0047] Geolocation—absolute position obtained from GPS (a satellite-based navigation system consisting of a network of orbiting satellites), radio-frequency communication with cellular towers or other means
[0048] Proximity—location or distance relative to a geolocation, person or object.
[0049] Ping—a computer network administration utility used to test the reachability of a host on an Internet Protocol (IP) network and to measure the round-trip time for messages sent from the originating host to a destination computer
[0050] Annunciation—a sound, vibration, light or other means of notifying a participant of a prompt.
[0051] Trigger—one or more pre-determined conditions that cause a Survey to be presented on a Participant Device.
[0052] Prompt—information presented to a participant, including but not limited to, a statement, recommendation, command or question.
[0053] Participant Response—information provided by a Participant through a Participant Device.
[0054] Context Data—data that describes the content of the data including but not limited to time and location.

DETAILED DESCRIPTION OF THE INVENTION

System Overview

[0055] The present invention is a system to allow a Researcher (101) to easily and dynamically manage the collection and synchronization of data of various types from one or more Participants (111) via a Participant Device (108), then to process, validate and review the returned data. For ease of understanding, examples in this description employ terminology from Javascript® for Android® on participant devices and on operations on a server use SQLite® and php script. One skilled in the art will be familiar with essentially equivalent operations and terminology used on other systems.

[0056] FIG. 1 is a block diagram of one implementation of such a system. In FIG. 1 the boxes are elements of the system and arrows indicate information flow between elements.

[0057] The Server Database (107) is a relational database such as provided by MySQL or Oracle. It stores data about the Participants and the study being conducted by the Researcher, Metadata about the data to be collected, and the data collected. In our implementation, the data is stored in tables that are in 3^rdnormal form and data integrity is enforced with foreign keys. An example of tables and structure for the Server Database is shown in FIG. 5. This example is for a study using Smartphones as the Participant Devices and collecting only Participant Response data. The Server Database will be customized, expanded or contracted for each study, depending on the data to be collected. Examples of data that could be collected include physical or physiologic sensor signals, Participant Responses, images, GPS data and audio notes or voice annotations by the Participant. The tables in FIG. 5 are:

[0058] Study (501)—master table holding the organization and Researchers responsible for studies.
[0059] Survey (502)—a child of the Study table dedicated to a unique study.
[0060] Questions (503)—a child of the Survey table that holds unique questions for a study.
[0061] QuestionType (504)—a table holding available types of questions that enforces referential integrity to the Question table.
[0062] Options (505)—a child of the Question table that holds multiple options choices for questions.
[0063] CellPhoneUsers (506)—a table that holds the unique ID, such as a Participant Device IMEI, that is tied to the Survey table via a foreign key.
[0064] Answers (508)—a table that holds all the answers that Participants answered on their Participant Device and uploaded to the remote Server
[0065] Alerts (509)—a table that holds all the alerts that will be activated on a Participant Device when a trigger has been activated.
A Researcher interfaces with the system via web pages served up by the Web Server (102) running the Web App (103). The Web App allows the Researcher to:
- [0066] Create a Data Request, for example, create Surveys, Triggers, Prompts or Annunciations. Triggers and Prompts allow a Researcher to initiate an interaction with a Participant, start or stop a software routine or request specific information recorded by the Participant Device.
- [0067] Enter Participant data
- [0068] Extract and view Participant Responses and context data related to Participant Responses or Items.

[0069] The Web App interfaces with the Server Database (107) to store data entered by the Researcher and to extract data for viewing or analysis by the Researcher. The Web App also will create transport files based on Researcher input to create a Data Request. The transport files (104) serve as a mechanism to easily transfer a Data Request to Participant Devices. This is described in more detail later.

[0070] Each Participant carries a Participant Device running a Participant Device App (109) provided by the Researcher. The Participant Device App interfaces with the Participant via a User Interface that can present Annunciations and Items setup by the Researcher. The Participant Device App creates a Participant Device Database (110), which may be a relational database, to store data collected by the Participant Device or entered Participant Responses and to store information about the Data Requests from the Researcher. The Participant Device App interfaces with the Server App (105) to download new Data Requests in the form of the transport files created by the Web App and to upload the data collected from the Participant Device or entered by the Participant to the Server Database.

[0071] The Web App, Server App, and Server Database may be located on a single Server or virtual Server or may be distributed across multiple Servers.

Detailed Description of Process Implementation

Create Data Request (201)

The web-based portion of the process has three major functions:

[0072] 1. The creation of a Data Request via input from a web page (202)

[0073] 2. Data Request data written to Server Database (203)

[0074] 3. Creation of an transport file (204)

A Data Request is created by presenting a web page that prompts the Researcher to fill in data. The Web Application Data Request Form will have two main sections comprising a Trigger scheduler and a Survey designer.

Trigger Scheduler (FIG. 3)

[0075] A scheduled Trigger will result in the Participant Device App performing an action initiated by the occurrence of an event, the Trigger event. Through the Web App, a Researcher will be able to setup and configure one or multiple Triggers to be scheduled on one or multiple Participant Devices. The Trigger types can include but are not be limited to:

- [0076] time of day
- [0077] activity based on internal or external accelerometer data
- [0078] location based upon GPS position
- [0079] location based upon GPS position of friends
- [0080] answers to Survey questions
  The actions can include but are not limited to:
- [0081] prompt the Participant to take some action (such as view or respond to a Survey, take a picture and store the image, provide voice or text annotation for other data)
- [0082] record data from sensors associated with the Participant Device (such as location transceiver, accelerometer, gyroscope, light, temperature, or through local area communication)

[0083] The Triggers will have additional options that specify the details of how the Trigger will be executed (301). When the researcher completes the Trigger scheduling process, the data is written to the Server Database (203) via a php script and a transport file (204) (an XML example is displayed in the data transfer section below) is created by a php script that contains tags and attributes that describe the Metadata and the underlying data. The transport file is stored in a directory on the Server that is accessible to the Participant Device. An alternative to the creation of a file would be to create an formatted data stream instead of a file. This would eliminate the need to manage the deletion of files after the data is imported into the Participant Device database.

[0084] The Participant Device Application includes logic to monitor changes to the Server Database (107) SystemUpdates table and set a change flag when changes occur. The transport file is downloaded to the Participant Device and the new Trigger schedule is loaded into a local relational database (207).

Survey Designer (FIG. 4)

[0085] The Data Request Form also stores and retrieves data from the Server Database (107) that allows for the management of multiple Surveys. The Survey designer is a collection of files and database tables for managing Surveys that encompass a cycle of data and programming scripts to act on that data and display it and scripts that collect and store changes to the data and finally notify Participant Devices of the change. Surveys are prepared for deployment from tables in the Survey Database and may comprise:

- [0086] survey name
- [0087] id tag to uniquely identify itself
- [0088] Researcher
- [0089] Valid date/time ranges for Presentation
- [0090] Display characteristics (e.g., font or color)
  Surveys are a collection of Items pointing to a single Survey in a parent-child relationship where the Survey is the parent and the Items are the children. The Question table contains the following columns:
- [0091] id tag to uniquely identify itself
- [0092] the text of the question
- [0093] type of question
- [0094] id of parent Survey
  All questions are assigned a question type and the list of valid question types is stored in a table called QuestionType (504). This table is linked to the Question table and all questions must contain a question type contained in the QuestionType table. The table contains the following columns:
- [0095] id to identify a question type
- [0096] description that further describes the question type
  The QuestionType table holds values that describe the type of Participant Response expected in answer to a question, these include:
- [0097] Text
- [0098] Single choice
- [0099] Multiple choice
- [0100] Date/time
- [0101] Body weight or other numeric
- [0102] Record voice or sound
- [0103] Photo or image

[0104] When Participants are presented with questions with expected form of answers, including the single choice, multiple choice, text input, numeric input, image capture and voice record. For single choice responses the answers may be conveniently presented as radio buttons. Checkboxes are similarly convenient for multiple choice responses.

[0105] The data stored in the preceding tables needs to be displayed on a web page so the surveys can be created and modified. The first step for processing a Survey is to read the database with a programming script. Surveys are first presented to the Researcher as a list on a web page by calling a php script AjaxTest to retrieve a list of Surveys and present it on the web page.

[0106] From this point the Researcher will be able to manage Survey questions through controls on the Survey designer component of the Data Request Form (FIG. 4).

Managing survey questions is divided into five areas:

- [0107] 1. Adding questions. To add a question, the Researcher types the question into the question textbox (401). They will then choose the form of the question by clicking on the corresponding radio button (402). If the question is a single or multiple choice type question, the choice options can be created by clicking on the add question option and typing the option text into the text box that appears (403). If the Researcher decides this new option is not needed, it can be removed by selecting the remove option button. The process for saving the question and possible options is to first call an AJAX post function in javascript that collects the entered data and passes it to a php script. The php script will extract the data and load it into a local array. It will then write the data into the appropriate tables and return a status flag reflecting the success of failure of the operation.
- [0108] 2. Deleting questions. Existing questions can be deleted by clicking on a button placed next to all existing questions (404). The process for deleting a question is accomplished by calling and AJAX post function in javascript that passes the id of the question to a php script that runs an SQL query to delete the question which in turn deletes any options by using a foreign key command, cascade on delete.
- [0109] 3. Viewing existing options. Existing question options can be viewed by clicking on the options button next to it (405 & 406). The click event calls a javascript function that loads the options from the Server Database using Ajax programming techniques. Ajax is used for displaying options dynamically, and it will eliminate the need to refresh the entire page when only a small part of the Survey is being modified.
- [0110] 4. Ordering Questions. Questions can be reordered by clicking and dragging questions higher or lower until they are in the order desired. The reordering is implemented using Javascript and php sort functions. Survey design attributes such as background color or font can also be modified (407 and 408).
- [0111] 5. Branching. The Survey software is capable of branching to multiple questions based upon the answer the participant chooses. Questions have a branching attribute which points to a branching table that changes the order of the questions and ensures the Survey returns to correct subsequent Survey question. Branching in the Application would take the following steps.
  - [0112] a) Researcher selects a question that would branch (701).
  - [0113] b) Options of the branching questions would be assigned a destination question (702).
  - [0114] c) Question set as a destination question would be tagged as a destination question (703).
  - [0115] d) Logic in Application would ensure question tagged as destination question proceeds to the next question properly (704).
    Commit Request Form data to Database (203)

[0116] The data from the Request Form is written to the Server Database tables that have been designed along relational database rules. Writing the data to a Server Database instead of directly writing an XML file allows the data from the Request Form to be recalled and modified if needed. To save the Survey, the Researcher clicks the Submit button (409) and a javascript function called CreateXML collects data entered into the controls on the web page and passes them down to a php script called SurveySubmit.php. This php script commits all the data to the Survey, Question and QuestionOption tables.

Create Transport File (204)

[0117] The transport file is created by reading the Server Database and writing the data specified in the Request Form in XML format. A script called surveySubmit.php reads the Survey, Question and QuestionType tables and creates an XML file like the example below. The created

[0118] XML files will be based upon the unique identifier that is assigned to each Participant Device. Another alternative to the creation of a file would be to create an XML data stream instead of a file. This would eliminate the need to manage the deletion of files after the data is imported into the Participant Device database.

Transfer Data (205)

[0119] The process to transfer the transport file from the Server to the Participant Device is initiated from the Participant Device. Each Participant Device has a unique identifier that is stored in a table with other useful details about the Participant Device that is sent to the Server App to identify which transport file to Download. The data transfer mechanism will be a network protocol initiated from the Participant Device that will pull the Survey transport file down from the Server (206). A table called SystemUpdates holds a list of all updates to system files like the Survey XML file. The Download process will use the HTTP protocol to Download the transport file. The transport file, based on XML, will contain Metadata inserted into XML attributes alongside the actual questions. Another alternative to initiate the Download of the transport file would be to use the Android Cloud to Device messaging system. This would involve registering the Web Server with Google and creating a series of messages concerning transport file creation. The Participant Device App would then be modified to monitor Android Broadcast messages from the Android operating system. The Participant Device App would receive a message whenever the Server Database SystemUpdates table changes and could then start the process to Download the Survey XML data.

Example of a Survey Transport table based on XML

<?XML version=“1.0”?>

<root>

</Question>

</Question>

</Question>

</Question>

</Question>

</Survey>

</root>

[0120] The transport file will be downloaded every time the Participant Device App contacts the Server and determines updates have been made to the Triggers and Surveys assigned to that

[0121] Participant Device. This file contains the instructions for the creation of Triggers and Prompts on the Participant Device.

[0122] Example of Transport Alert Manager File:

<root>

[0123] <Items>

- [0124] <TPAItem ID=‘103’ TriggerName=‘Test 4’ TriggerType=‘3’ SurveyID=‘5’/>
- [0125] <TPAItem ID=‘104’ TriggerName=‘Post Meal l’ TriggerType=‘3’ SurveyID=‘0’/>
- [0126] <TPAItem ID=‘105’ TriggerName=‘Post Meal 2’ TriggerType=‘3’ SurveyID=‘2’/>
- [0127] <TPAItem ID=‘106’ TriggerName=‘Test’ TriggerType=‘2’ SurveyID=‘1’>
- [0128] <TPAItem ID=‘115’ TriggerName=‘Random Morning’ SurveyID=‘1’/>
- [0129] <TPAItem ID=‘116’ TriggerName=‘Final 1’ TriggerType=‘3’ SurveyID=‘0’>

[0130] </Items>

[0131] <Attributes>

- [0132] <Attribute Trig TimeBased ItemID=‘103’ Start=‘09:00:00’ End=‘12:00:00’/>
- [0133] <Attribute Trig TimeBased ItemID=‘104’Start=‘00:00:00’ End=‘00:00:00’/>
- [0134] <Attribute Trig TimeBased ItemID=‘105’ Start=‘00:00:00’ End=‘00:00:00’/>
- [0135] <Attribute Trig TimeBased ItemID=‘106’ TriggerTime=‘06:30:00’/>
- [0136] <Attribute Trig TimeBased ItemID=‘115’ Start=‘15:00:00’ End=‘18:00:00’/>
- [0137] <Attribute Trig TimeBased ItemID=‘116’ Start=‘00:00:00’ End=‘00:00:00’/>

[0138] </Attributes>

</root>

Collect Data (208)

[0139] Triggers: The Trigger management logic of the Participant Device App has two components: Trigger Listeners and Trigger Handlers. When the transport file is downloaded, the information of the active Triggers and the corresponding actions are put into the Participant Device Database (207), and an Trigger configuration process is run. During the Trigger configuration process, active Triggers are registered with the Trigger Listeners. The role of the Trigger Listener is to detect or monitor for Trigger events and at that time send a message to the Trigger Handler that the event has transpired. An example of this is the location based trigger event, in which if a location based Trigger type has been registered, the Trigger Listener polls the location of the device periodically and compares to a registered location and radius. If the current location moves within the distance to the registered location, the Trigger Listener notifies the Trigger Handler that the location based event has transpired.

[0140] The Trigger Handler receives a notification that the Trigger event has occurred and through the Participant Device Database looks up what action should be taken based on the scheduled Triggers. The Trigger Handler then runs the logic to give the Annunciation and take the appropriate action. An example of this is the action notifying the Participant to take a Survey triggered by the location of the Participant Device (209).

Collection of Survey Data.

[0141] The screen that displays the Survey questions is not a standard static screen that is normally displayed in Participant Devices. The Survey screen for the Mobile Application starts out as a blank screen. The typical Participant Device screen (a graphical User Interface screen) is based upon an XML file that is created before the Application is compiled and any change to the form requires a compiled Application. The concept of a graphical User Interface created by a developer during the design phase of an Application has the advantage of reduced complexity but this approach results in additional development time and cost when specifications change. With the dynamic Participant Device screen, a java function retrieves Metadata information from the Survey table in the Participant Device Database and creates the basic design of the screen (FIG. 6).

[0142] The background color, font and border factors are committed to the screen by reading the values taken from a Participant Device Database table. It then establishes variables as counters to track factors such as current question, current session, etc. Two buttons are displayed on the screen, named Previous and Next and activated in a prebuilt frameset as a first step in the building of the screen. These two buttons allow the Participant to navigate through the Survey (601). Basic screen setup factors such as fonts, colors and borders are set based on data read from the database (603). When this has been completed, the first question of the Survey is pulled from the database. The Survey question is then displayed (602) below the navigation buttons and the program then determines the type of question and a function appends an additional view based on the type of question. (604). There are currently five types of questions:

- [0143] Single choice questions displayed as a list of radio buttons. For single choice question, a series of radio button controls are created based on the question options and the options in turn are added to a radio group view and this radio group is appended to the screen. Each radio button has an OnClickListener event attached to it so the radio button will respond to the participant clicking the button.
- [0144] Multiple choice questions displayed as a list of check boxes. For multiple choice questions, a series of checkboxes are created based on the question options and each checkbox is added to a view. Each checkbox has an OnClickListener event attached to it so the checkbox will respond to the participant clicking the checkbox.
- [0145] Questions requiring text and displayed as a text box. The text question has an EditText control appended to the screen and the EditText control has an OnClickListener event attached to it.
- [0146] Date/time related questions displayed as a date time control. The Date/Time question has a TimePicker popup dialog control attached to it. This control sets it's date and time to the current date and time. Within the TimePicker control, an event function called on TimeSet captures the participant date/time selection.
- [0147] Questions requiring a voice recording. The voice recording screen is created by adding a record image button and a stop recording image button. The two buttons have a OnClickListener event attached and the click events will manage a MediaRecorder control.

[0148] All question items require an event that captures Participant interaction so the Application will know when an item has been selected. An individual listener event is assigned to each detail that will mark all selected items. With the question on the screen, the Application waits for the Participant to click the NEXT button (602). The selected values for the question are collected and written to a table in the Participant Device Database with the exception of voice recording. Voice recordings are saved as separate files with the name of the file describing the participant and date of recording (210). The participant can also choose the Previous button provided they are past the first question (601). The function that manages the previous button will remove any answers from the previous question and then load the appropriate question.

[0149] When all of the Survey questions are answered, a function will group the answers as a unique event by the use of a session identifier, capture timestamps to measure Participant performance while answering questions then write the answers to the Answers table in the Participant Device database (605).

Transfer Data to Server Database (211)

[0150] The transfer of captured Participant Device data will involve pulling data out of the Participant Device Database and writing it to a file for transport. This process will be accomplished by using SQL (Structured Query Language) to create an output file. The naming of the file will help to identify the source. The filename will contain the user id and a date timestamp and a counter to give the file a unique identifier. The file can be comma delimited, straight text of a binary file, depending on how the Server App (105) is designed to process the file. The amount and type of data to transfer will be based upon settings in the Participant Device App. Once the file has been created, the Participant Device will invoke the Server App (105) to pull the file up and process it into the Database Server (106) using the HTTP post protocol.

[0151] An alternative method to uploading Participant Device data as a file is to read the Participant Device database and store the data in an array as key/pair values. The data is uploaded using the HTTP post protocol as each record is read from the database.

Validation of Data (212)

[0152] Uploaded data will be reviewed by the Server App to ensure it meets any validation requirements set on the Create Data Request Form (201). Data will also be validated by use of foreign keys on the tables that ensure data integrity. Any resulting errors will be captured, stored and then displayed on an exception web page.

Review/Analyze Data (213)

[0153] With the data loaded into the Database Server, the Server App will have functions that allow the Researcher a view into the uploaded data by means of reports and scripts. A web page will be created that displays the researcher name and institution. The page will have a calendar control so the researcher can view one or more days' worth of Survey answers. A list box will contain the names of the participants that have uploaded data. The answer data will be pulled from the answer table and joined with the question data and a timestamp through an SQL query. Further reports can be constructed as needed. The SQL query will be constructed in a php script that is called by the web page using AJAX programming techniques and will require a javascript function to populate the page.

Alternative Methods for Creating Surveys on Participant Devices

[0154] A Survey may be created for a Participant Device by using programming tools provided by the Participant Device's software development kit (SDK). The User Interface is designed in an integrated development environment and compiled into the Application when desired. Logic for displaying questions and saving answers is written specifically for the previously designed User Interface. Multiple surveys will require the creation of additional User Interfaces and logic to populate and retrieve data from them. The entire Application is compiled and loaded into the Participant Device. This method is effective but requires a programmer to create the User Interface and any ensuing changes.

[0155] Another method of using a Survey on a Participant Device is to use a Survey based upon a web page and running that web page from a browser contained in the Participant Device. This allows for an easily modified Survey but with the disadvantage of complete failure if there is no data connection.

[0156] PDA devices are capable of displaying and recording Survey information but typically do not have wireless connectivity. Surveys are designed on a personal computer with a custom Application that creates a Survey file. A Survey Application is loaded onto the PDA with the Survey file. The Survey Application reads the Survey file and the answers are copied off the PDA. Because most PDA do not have wireless connectivity, the PDA must be physically attached to the personal computer to copy the Survey file and the resulting answers.

Claims

Certificate of Correction present

The claims shown below may not include correction changes. Use the corrected PDF for authoritative text.

What we claim is:

1. A system for managing interactive surveys, comprising:

a server including a first table in a first database on the server to store metadata that describes and controls presentation of a survey comprising a data request or other assemblage of one or more items to be presented using the metadata on a participant device;

a participant device including a processor, the participant device configured for providing the items including a prompt and an associated answer when the prompt is in the form of a question presented to the participant as part of the survey;

the server including a second table in the first database containing one or more items that comprise the survey, said items comprising information to be presented to a participant;

a web service coupled to the first database that allows a researcher to create the meta data and items;

the server including a third table in the first database that contains identification and type information for the participant device in the possession of the participant;

the server including instructions on the server to encapsulate the survey in a transport file formatted to be compatible with the device based on the type information;

a network connection between the server and the device;

the processor including instructions on the device to initiate and control download of the transport file from the server to the device based on the device identification;

the participant device including a second database on the device for receiving the survey;

the processor instructions on the device to load the survey from the transport file into the second database; and

the processor including instructions on the device to present the one or more items in the survey to the participant according to the meta data; and

the processor including instructions on the device to present the survey to the participant when motion recorded from an accelerometer associated with the device meets a pre-determined threshold of magnitude or duration of interest.

2. The system of claim 1 wherein the web service enables the researcher to enter answers for items that ask a question.

3. The system of claim 2 wherein the web service enables the researcher to enter the format for the answers.

4. The system of claim 1 wherein the processor further comprises instructions to present the survey when the device is within a pre-determined proximity of a location of interest.

5. The system of claim 4 wherein the web service enables the researcher to enter a location and proximity of interest.

6. The system of claim 1 wherein the web service enables the researcher to enter a magnitude or duration of interest for motion of the device.

7. The system of claim 1 wherein the processor further comprises instructions to present the survey at a pre-defined date and time.

8. The system of claim 7 wherein the web service enables the researcher to enter a date and time for the survey to be presented.

9. The system of claim 1 wherein the processor further comprises instructions to present the survey at a random time within a pre-defined beginning and ending date and time.

10. The system of claim 9 wherein the web service enables the researcher to enter the beginning and ending date and time for survey to be presented.

11. The system of claim 1 further comprising transceivers in a plurality of devices receptive to signals from the other devices to determine distance between devices.

12. The system of claim 11 wherein the processor further comprises instructions to present the survey when one of the plurality of devices is within a pre-determined proximity of the device.

13. The system of claim 11 wherein the web service enables the researcher to activate or deactivate the instructions to determine proximity to other devices.

14. The system of claim 11 wherein at least one of the server or the processor includes instructions to record the date and time whenever the device is within a pre-determined proximity of another device.

15. The system of claim 1 wherein the third table contains information on devices in the possession of a plurality of participants.

16. The system of claim 15 wherein the web service enables the researcher to select more than one participant to receive the survey from among the plurality of participants.

17. The system of claim 1 wherein the transport file is in XML format.

18. The system of claim 1 wherein the transport file is in Json format.

19. A method of managing interactive surveys, the method comprising:

a researcher entering meta data for describing and controlling presentation of a survey into a table in a first database on a server, the survey comprising a data request or other assemblage of one or more items to be presented using the metadata on a participant device, the items including a prompt and an associated answer when the prompt is in the form of a question presented to a participant as part of the survey;

the researcher entering one or more items comprising information to be presented to a participant into a second table in the first database;

assembling the meta data and items from the first and second tables in the first database into a survey on the server;

selecting a device in the possession of a participant to receive the survey;

encapsulating the survey into a transport file appropriate for the device;

downloading the transport file to the device;

loading the transport file into a second database on the device;

extracting the survey from the second database; and presenting the survey to the participant when motion recorded from an accelerometer associated with the device meets a pre-determined threshold of magnitude or duration of interest.

20. The method of claim 19 wherein one or more of the items in the survey is a question.

21. The method of claim 20 further comprising capturing and returning participant responses to question items.

22. The method of claim 21 further comprising recording a first time at which each item is presented to the participant and a second time at which the participant completes their response to the item.

23. The method of claim 19 wherein one or more of the items in a survey is a request for the participant to take an action.

24. The method of claim 19 further comprising entering a trigger condition for one or more items into a third table of the first database; including the trigger conditions in the survey assembled on the server; and presenting the survey to the participant when the conditions defined by the trigger are met.

25. The method of claim 24 wherein the trigger condition is a time of day.

26. The method of claim 25 wherein the trigger condition is a random time within a pre-defined beginning and ending time of day.

27. The method of claim 24 wherein the trigger condition is proximity to a pre-defined location.

28. The method of claim 27 wherein the participant remains within proximity to the pre-defined location for a pre-defined number of minutes.

29. The method of claim 24 wherein the trigger condition is a pre-defined number of minutes either above or below a pre-defined threshold of motion recorded on an accelerometer sensor.

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Abstract

Description

CROSS-REFERENCE TO RELATED PATENT DOCUMENT

FIELD OF THE INVENTION

BACKGROUND OF THE INVENTION

OBJECTS OF THE INVENTION

[0009] This invention allows a Researcher, to:

- [0010] create and modify Surveys and Items for individual Participants or groups of Participants;
- [0011] create Prompts and Annunciations that can be independent or associated with the Surveys;
- [0012] associate the Annunciations and presentation of the Items with Triggers related to predetermined conditions;
- [0013] deploy the Surveys to Participant Devices;
- [0014] present the Surveys to the Participants on demand or in response to Triggers and gather Participant Responses;
- [0015] gather, organize and attach context to Prompts and Participant Responses;
- [0016] return the Participant Responses to a remote Server or database;
- [0017] organize and store the Participant Responses and present them to the Researcher and/or Participant or to predetermined algorithms for automated actions.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a block diagram of the system components and flow of information.

[0020] FIG. 3 is an example of a web page to create annunciations, triggers or prompts.

[0021] FIG. 4 is an example of a web designer form to create Survey questions.

[0022] FIG. 5 is an entity relationship diagram of the Server Database tables and their relationship to each other.

[0023] FIG. 6 is an example of a Survey presentation on a Participant Device.

[0024] FIG. 7 is an example of a Survey question with the branching option.

[0025] FIG. 8 is a summary view of the dynamic Survey/Trigger system.

GLOSSARY

[0026] Researcher—an investigator, clinician, other person or entity desiring to collect information from or interact with one or more Participants.
[0027] Participant—a patient or other person, often enrolled in a research study, with whom a Researcher wishes to interact to provide and gather information. Participant Device—computing device, typically having a display with touch or keyboard input, such as a personal computer or mobile device (e.g., smartphone or personal digital assistant).
[0028] App or Application—software program automatically performing singular or multiple related tasks.
[0029] Server—a computer, or assemblage of computers, that link other computers or electronic devices together, providing services across a network such as the internet.
[0030] Web Server—a computer program running on a server that delivers (serves) and receives content over the internet.
[0031] Database Server—a computer program that provides database services to other computing devices, such as personal computers or Participant Devices.
[0032] Data Request—request for data from an application operating on a device separate from the device receiving the request.
[0033] Survey—a data request or other assemblage of one or more Items to be presented according to metadata and other characteristics on a Participant Device
[0034] Item—a Prompt, and associated answers if the Prompt is in the form of a question, presented to a Participant as part of a Survey
[0035] User Interface—a part of an Application that controls a display for a Researcher or the Participant that allows the Researcher or Participant to interact with the system
[0036] Metadata—data that provides context or additional information about other data and/or its means of presentation.
[0037] php script—a web-based Application that is executed by a Web Server
[0038] XML—extensible markup language is a set of rules for encoding documents electronically
[0039] Transport file—a structured file, such as XML or Json, containing one or more Surveys to facilitate download to a Participant device.
[0040] Download—the transfer of a Transport file or other data from a Server to a Participant device
[0041] Upload—the transfer of Survey information and other data from a Participant device to a Server
[0042] PDA—personal digital assistant
[0043] Compile—the process of creating an Application from source code
[0044] Json—javascript object notation is a format for encoding data or code electronically
[0045] AJAX—asynchronous javascript with XML is a method to create client based interactive web applications
[0046] Buddy Box—a radio transponder to notify a Participant Device it is at a specific location.
[0047] Geolocation—absolute position obtained from GPS (a satellite-based navigation system consisting of a network of orbiting satellites), radio-frequency communication with cellular towers or other means
[0048] Proximity—location or distance relative to a geolocation, person or object.
[0049] Ping—a computer network administration utility used to test the reachability of a host on an Internet Protocol (IP) network and to measure the round-trip time for messages sent from the originating host to a destination computer
[0050] Annunciation—a sound, vibration, light or other means of notifying a participant of a prompt.
[0051] Trigger—one or more pre-determined conditions that cause a Survey to be presented on a Participant Device.
[0052] Prompt—information presented to a participant, including but not limited to, a statement, recommendation, command or question.
[0053] Participant Response—information provided by a Participant through a Participant Device.
[0054] Context Data—data that describes the content of the data including but not limited to time and location.

DETAILED DESCRIPTION OF THE INVENTION

System Overview

[0056] FIG. 1 is a block diagram of one implementation of such a system. In FIG. 1 the boxes are elements of the system and arrows indicate information flow between elements.

[0058] Study (501)—master table holding the organization and Researchers responsible for studies.
[0059] Survey (502)—a child of the Study table dedicated to a unique study.
[0060] Questions (503)—a child of the Survey table that holds unique questions for a study.
[0061] QuestionType (504)—a table holding available types of questions that enforces referential integrity to the Question table.
[0062] Options (505)—a child of the Question table that holds multiple options choices for questions.
[0063] CellPhoneUsers (506)—a table that holds the unique ID, such as a Participant Device IMEI, that is tied to the Survey table via a foreign key.
[0064] Answers (508)—a table that holds all the answers that Participants answered on their Participant Device and uploaded to the remote Server
[0065] Alerts (509)—a table that holds all the alerts that will be activated on a Participant Device when a trigger has been activated.
A Researcher interfaces with the system via web pages served up by the Web Server (102) running the Web App (103). The Web App allows the Researcher to:
- [0066] Create a Data Request, for example, create Surveys, Triggers, Prompts or Annunciations. Triggers and Prompts allow a Researcher to initiate an interaction with a Participant, start or stop a software routine or request specific information recorded by the Participant Device.
- [0067] Enter Participant data
- [0068] Extract and view Participant Responses and context data related to Participant Responses or Items.

[0071] The Web App, Server App, and Server Database may be located on a single Server or virtual Server or may be distributed across multiple Servers.

Detailed Description of Process Implementation

Create Data Request (201)

The web-based portion of the process has three major functions:

[0072] 1. The creation of a Data Request via input from a web page (202)

[0073] 2. Data Request data written to Server Database (203)

[0074] 3. Creation of an transport file (204)

Trigger Scheduler (FIG. 3)

- [0076] time of day
- [0077] activity based on internal or external accelerometer data
- [0078] location based upon GPS position
- [0079] location based upon GPS position of friends
- [0080] answers to Survey questions
  The actions can include but are not limited to:
- [0081] prompt the Participant to take some action (such as view or respond to a Survey, take a picture and store the image, provide voice or text annotation for other data)
- [0082] record data from sensors associated with the Participant Device (such as location transceiver, accelerometer, gyroscope, light, temperature, or through local area communication)

Survey Designer (FIG. 4)

- [0086] survey name
- [0087] id tag to uniquely identify itself
- [0088] Researcher
- [0089] Valid date/time ranges for Presentation
- [0090] Display characteristics (e.g., font or color)
  Surveys are a collection of Items pointing to a single Survey in a parent-child relationship where the Survey is the parent and the Items are the children. The Question table contains the following columns:
- [0091] id tag to uniquely identify itself
- [0092] the text of the question
- [0093] type of question
- [0094] id of parent Survey
  All questions are assigned a question type and the list of valid question types is stored in a table called QuestionType (504). This table is linked to the Question table and all questions must contain a question type contained in the QuestionType table. The table contains the following columns:
- [0095] id to identify a question type
- [0096] description that further describes the question type
  The QuestionType table holds values that describe the type of Participant Response expected in answer to a question, these include:
- [0097] Text
- [0098] Single choice
- [0099] Multiple choice
- [0100] Date/time
- [0101] Body weight or other numeric
- [0102] Record voice or sound
- [0103] Photo or image

[0106] From this point the Researcher will be able to manage Survey questions through controls on the Survey designer component of the Data Request Form (FIG. 4).

Managing survey questions is divided into five areas:

- [0107] 1. Adding questions. To add a question, the Researcher types the question into the question textbox (401). They will then choose the form of the question by clicking on the corresponding radio button (402). If the question is a single or multiple choice type question, the choice options can be created by clicking on the add question option and typing the option text into the text box that appears (403). If the Researcher decides this new option is not needed, it can be removed by selecting the remove option button. The process for saving the question and possible options is to first call an AJAX post function in javascript that collects the entered data and passes it to a php script. The php script will extract the data and load it into a local array. It will then write the data into the appropriate tables and return a status flag reflecting the success of failure of the operation.
- [0108] 2. Deleting questions. Existing questions can be deleted by clicking on a button placed next to all existing questions (404). The process for deleting a question is accomplished by calling and AJAX post function in javascript that passes the id of the question to a php script that runs an SQL query to delete the question which in turn deletes any options by using a foreign key command, cascade on delete.
- [0109] 3. Viewing existing options. Existing question options can be viewed by clicking on the options button next to it (405 & 406). The click event calls a javascript function that loads the options from the Server Database using Ajax programming techniques. Ajax is used for displaying options dynamically, and it will eliminate the need to refresh the entire page when only a small part of the Survey is being modified.
- [0110] 4. Ordering Questions. Questions can be reordered by clicking and dragging questions higher or lower until they are in the order desired. The reordering is implemented using Javascript and php sort functions. Survey design attributes such as background color or font can also be modified (407 and 408).
- [0111] 5. Branching. The Survey software is capable of branching to multiple questions based upon the answer the participant chooses. Questions have a branching attribute which points to a branching table that changes the order of the questions and ensures the Survey returns to correct subsequent Survey question. Branching in the Application would take the following steps.
  - [0112] a) Researcher selects a question that would branch (701).
  - [0113] b) Options of the branching questions would be assigned a destination question (702).
  - [0114] c) Question set as a destination question would be tagged as a destination question (703).
  - [0115] d) Logic in Application would ensure question tagged as destination question proceeds to the next question properly (704).
    Commit Request Form data to Database (203)

Create Transport File (204)

Transfer Data (205)

Example of a Survey Transport table based on XML

<?XML version=“1.0”?>

<root>

</Question>

</Question>

</Question>

</Question>

</Question>

</Survey>

</root>

[0120] The transport file will be downloaded every time the Participant Device App contacts the Server and determines updates have been made to the Triggers and Surveys assigned to that

[0121] Participant Device. This file contains the instructions for the creation of Triggers and Prompts on the Participant Device.

[0122] Example of Transport Alert Manager File:

<root>

[0123] <Items>

- [0124] <TPAItem ID=‘103’ TriggerName=‘Test 4’ TriggerType=‘3’ SurveyID=‘5’/>
- [0125] <TPAItem ID=‘104’ TriggerName=‘Post Meal l’ TriggerType=‘3’ SurveyID=‘0’/>
- [0126] <TPAItem ID=‘105’ TriggerName=‘Post Meal 2’ TriggerType=‘3’ SurveyID=‘2’/>
- [0127] <TPAItem ID=‘106’ TriggerName=‘Test’ TriggerType=‘2’ SurveyID=‘1’>
- [0128] <TPAItem ID=‘115’ TriggerName=‘Random Morning’ SurveyID=‘1’/>
- [0129] <TPAItem ID=‘116’ TriggerName=‘Final 1’ TriggerType=‘3’ SurveyID=‘0’>

[0130] </Items>

[0131] <Attributes>

- [0132] <Attribute Trig TimeBased ItemID=‘103’ Start=‘09:00:00’ End=‘12:00:00’/>
- [0133] <Attribute Trig TimeBased ItemID=‘104’Start=‘00:00:00’ End=‘00:00:00’/>
- [0134] <Attribute Trig TimeBased ItemID=‘105’ Start=‘00:00:00’ End=‘00:00:00’/>
- [0135] <Attribute Trig TimeBased ItemID=‘106’ TriggerTime=‘06:30:00’/>
- [0136] <Attribute Trig TimeBased ItemID=‘115’ Start=‘15:00:00’ End=‘18:00:00’/>
- [0137] <Attribute Trig TimeBased ItemID=‘116’ Start=‘00:00:00’ End=‘00:00:00’/>

[0138] </Attributes>

</root>

Collect Data (208)

Collection of Survey Data.

- [0143] Single choice questions displayed as a list of radio buttons. For single choice question, a series of radio button controls are created based on the question options and the options in turn are added to a radio group view and this radio group is appended to the screen. Each radio button has an OnClickListener event attached to it so the radio button will respond to the participant clicking the button.
- [0144] Multiple choice questions displayed as a list of check boxes. For multiple choice questions, a series of checkboxes are created based on the question options and each checkbox is added to a view. Each checkbox has an OnClickListener event attached to it so the checkbox will respond to the participant clicking the checkbox.
- [0145] Questions requiring text and displayed as a text box. The text question has an EditText control appended to the screen and the EditText control has an OnClickListener event attached to it.
- [0146] Date/time related questions displayed as a date time control. The Date/Time question has a TimePicker popup dialog control attached to it. This control sets it's date and time to the current date and time. Within the TimePicker control, an event function called on TimeSet captures the participant date/time selection.
- [0147] Questions requiring a voice recording. The voice recording screen is created by adding a record image button and a stop recording image button. The two buttons have a OnClickListener event attached and the click events will manage a MediaRecorder control.