Structured tailoring

• US 10,456,036 B2
• Filed: 06/18/2010
• Issued: 10/29/2019
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Wong, Daniel, Hasker, David, Brassington, Glenn, Weinert, Stefan, Soni, Abhishek S., Greenburg, Alan, Galley, Paul J., Porsch, Ulrich, Reinke, Robert E., De Polo, Marco
• Primary Examiner(s): Misiaszek, Amber A
• Application Number:
  US12/818,930
• Publication Number:
  US 20110145747A1
• Time in Patent Office: 3,420 Days
• Field of Search: 705 2- 4
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Embodiments related to a self-administered, behavior modification program facilitated through a structured tailoring method and system thereof which accelerates and enhances the internalization process of the individual, and which provides help when the individual begins to fail in adhering or continuing with the behavior modification are disclosed. Program instructions that when executed by a processor causes a processor to initiate automatically a schedule of events of a structured tailoring procedure upon entry criteria being met at some unknown time, provide intervention according to the intervention preferences when the adherence criteria for one of the events has not been met, and end automatically the structured collection procedure upon exit criteria being met at some unknown time.

Claims

1. A method of performing a self-administered, behavior modification program on a blood glucose meter which comprises facilitating a structured collection procedure for an individual which helps the individual change a current behavior to a target behavior and improves compliancy with the structured collection procedure, said method comprising:

providing the blood glucose meter loaded with the structured collection procedure and program instructions;

downloading the structured collection procedure from a server onto a client device, wherein software on the client computer serves as an interface between the server and the meter, wherein the server can only access information related to the installed version of the software and the server cannot access data in a database residing on the client device, wherein subsequent downloads of the particular structured collection procedure onto the client require access from an authorized client user;

measuring a biomarker comprising a blood glucose level with the blood glucose meter according to the structured collection procedure; and

executing the program instructions on the blood glucose meter causing a processor of the blood glucose meter to;

personalize the structured collection procedure by requesting goals from the individual to define for events to be accomplished in the structured collection procedure one or more adherence criteria that the processor uses to determine automatically whether each event was accomplished successfully and to define one or more exit criteria for ending the structured collection procedure, and requesting intervention preferences from the individual;

initiate automatically a schedule of the events defined in the structured collection procedure upon one or more entry criteria being met;

provide intervention automatically according to the intervention preferences when the one or more adherence criteria for one of the events is not met;

end automatically the structured collection procedure upon the one or more exit criteria being met, wherein the processor continues automatically with the next one of the events in the structured collection procedure until the one or more exit criteria is met; and

assign a unique identifier to the events, when the one or more adherence criteria are met, which corresponds to the events in the structured collection procedure; and

wherein the unique identifier is not assigned when the biomarker measurement is determined by the processor as not being close enough in time to a data event request based on a prescheduled time so as to facilitate the structured collection procedure and improve the compliancy with the structured collection procedure of a management system; and

providing a microprocessor, a memory, a power source, and an indicator, the indicator connected to the processor and which can operate under the control of the processor to emit audible, tactile, or visual alerts to the individual of daily times for the biomarker measurement; and

sending a message from the blood glucose meter to a physician when the individual fails to complete one of the one or more adherence criteria, wherein a communication link between a computer of the physician and the blood glucose meter can be established upon connection via the server.

2. The method according to claim 1 wherein the program instructions further cause the processor to perform an initial assessment of the individual to tailor both the events as well as the interventions provided by the structured collection procedure.

3. The method of claim 2, wherein the initial assessment is based on answers to catalog questions provided to the individual.

4. The method according to claim 2 wherein the initial assessment cover areas of readiness for change, current health, and activity level of the individual.

5. The method according to claim 2 wherein the program instructions further cause the processor to provide a recommendation based on the input received from the individual concerning the initial assessment.

6. The method according to claim 5 wherein the program instructions further cause the processor to use the recommendation as the one or more entry criteria.

7. The method according to claim 5 wherein the program instructions further cause the processor permit the individual to tailor the recommendation to his or her individual abilities and availability.

8. The method according to claim 1 wherein the program instructions further cause the processor to permit the individual to define the goals as short term goals, midterm goals, and a long-term goal.

9. The method according to claim 8 wherein the program instructions further cause the processor to automatically cycle through each of the goals defined by the individual upon successful completion of a previous goal.

10. The method according to claim 2 wherein the program instructions further cause the processor to provide a recommendation based on the input received from the individual concerning the initial assessment, and to define one of the goals as a short-term goal that is based on the results from the assessment and the recommendation.

11. The method according to claim 1 wherein the program instructions further cause the processor to provide upon request an education module which provides education material.

12. The method according to claim 11 wherein the education material contains health and behavior education in relation to the targeted behavior.

13. The method according to claim 11 wherein the education material include a skill assessment and skill development activities.

14. The method according to claim 1 wherein the program instructions further cause the processor to assess if the individual possesses the proper level of skill before moving into a new structured collection procedure.

15. The method according to claim 14 wherein the program instructions further cause the processor to provide skill development activities for the individual to complete in order to gain the skill for the new structured collection procedure if assess by the processor as not have the proper level of skill.

16. The method according to claim 1 wherein the program instructions further cause the processor to provide a behavior support assessment to ascertain from the individual what barriers and motivators in the past have assisted in success or failures when it comes to performing the target behavior.

17. The method according to claim 16 wherein the program instructions further cause the processor to provide a behavior-support intervention module in which the individual picks one or more pre-defined interventions based on the barriers and motivators ascertained from the individual.

18. The method according to claim 17 wherein the pre-defined interventions are selected from electronic alarms, reminders, messages, and prompting social support networks for help.

19. The method according to claim 17 wherein the program instructions further cause the processor to provide a validation module which ascertains whether an appropriate level of intervention is assigned due to an associated risk if one of the events fail to meet the one or more adherence criteria.

20. The method according to claim 1 wherein the schedule of events define how often progress will be monitored by the procedure.

21. The method according to claim 20 wherein the program instructions further cause the processor to monitor compliancy of the individual with the events by assessing whether the one or more adherence criteria have been met by the individual when performing each one of the events.

22. The method according to claim 1 wherein the program instructions further cause the processor to check whether there is an indication that the structured collection procedure is not working if the one or more exit criteria are not met.

23. The method according to claim 22 wherein the indication is provided to the processor by the individual or is shown in collected data associated with each one of the events.

24. The method according to claim 23 wherein where the indication is present, then the program instructions further cause the processor to query the individual as to whether the individual believes the procedure is working, whether the individual is following the intervention, or whether the individual is lacking in a skill or understanding of how attain the goals.

25. The method according to claim 24 wherein the program instruction further cause the processor to perform a health and behavior support assessment in order to work through the process of providing a new personalized collection procedure if the collection procedure is indicated as not working, to request again the intervention preferences from the individual if the individual indicates that the intervention is not being followed, and to provide education material or start a skill assessment module if the individual indicates a lack in skill or understanding.

28. The method according to claim 21 wherein the program instructions further cause the processor to stop the structured collection procedure if the one or more adherence criteria are not met and instructs the individual to contact a clinician.

29. The method of claim 1 further comprising executing the program instructions on the device causing the processor of the device to de-tag data records by nullifying the unique identifiers in a data file for data collected for a cancelled structured collection procedure.

30. The method of claim 1 wherein the data event request is designated as critical or non-critical, and time for the biomarker measurements for the critical request is extendible by the individual for pre-defined periods within the prescheduled time, and the time for the biomarker measurements for the non-critical request is extendible beyond the prescheduled time.

26. A method for performing a self-administered, behavior modification program of a management system on a blood glucose meter which comprises facilitating a structured collection procedure for an individual which helps the individual change a current behavior to a target behavior, said method comprising:

providing the blood glucose meter loaded with the structured collection procedure and program instructions, the blood glucose meter comprising;

a memory which stores the structured collection procedure; and

a processor connected to the memory; and

measuring a biomarker comprising a blood glucose level with the blood glucose meter and digitally storing the biomarker value in the memory of the blood glucose meter according to the structured collection procedure;

executing the program instructions on the blood glucose meter causing the processor of the blood glucose meter to;

personalize the structured collection procedure by requesting goals from the individual to define for events to be accomplished in the structured collection procedure one or more adherence criteria that the processor uses to determine automatically whether each event was accomplished successfully and to define one or more exit criteria for ending the structured collection procedure, and requesting intervention preferences from the individual;

initiate automatically a schedule of the events defined in the structured collection procedure upon one or more entry criteria being met;

store in the memory data collected in accordance to the schedule;

provide intervention automatically according to the intervention preferences when the one or more adherence criteria for one of the events is not met;

end automatically the structured collection procedure upon the one or more exit criteria being met, wherein the processor continues automatically with the next one of the events in the structured collection procedure until the one or more exit criteria is met;

assign a unique identifier to the events, when the one or more adherence criteria are met, which corresponds to the events in the structured collection procedure; and

wherein the unique identifier is not assigned when the biomarker measurement is determined by the processor as not being close enough in time to a data event request based on a prescheduled time so as to facilitate the structured collection procedure and improve the compliancy with the structured collection procedure of the management system; and

providing a microprocessor, a power source, and an indicator, the indicator connected to the processor and which can operate under the control of the processor to emit audible, tactile, or visual alerts to the individual of daily times for the biomarker measurement; and

sending a message from the blood glucose meter to a physician when the individual fails to complete one of the one or more adherence criteria, wherein a communication link between a computer of the physician and the blood glucose meter can be established upon connection via a web server.

27. A method for performing a self-administered, behavior modification program on a blood glucose meter which comprises facilitating a structured collection procedure for an individual which helps the individual change a current behavior to a target behavior and improves compliancy with the structured collection procedure, the method comprising:

providing the blood glucose meter loaded with a master protocol comprising sub-protocols of various structured collection procedures and program instructions, each of the various structured collection procedures address a goal that addresses the target behavior and comprises entry criteria and exit criteria, wherein entry criteria of some of the various structured collection procedures is met upon exit criteria of previous ones of the various structured collection procedures being met; and

measuring a biomarker comprising a blood glucose level with the blood glucose meter and digitally storing the biomarker value in a memory of the blood glucose meter according to the structured collection procedure; and

executing the program instructions on the blood glucose meter causing a processor of the blood glucose meter to;

personalize the structured collection procedure by requesting goals from the individual to define for entry criteria to be accomplished in the structured collection procedure, one or more adherence criteria that the processor uses to determine automatically whether each event was accomplished successfully and to define an exit criterion for ending the structured collection procedure, and requesting intervention preferences from the individual;

use the entry criteria based on invention preferences from the individual of each of the various structured collection procedures to determine automatically which of the various structured collection procedures are first enabled in the master protocol,

run the master protocol with first enabled ones of the various structured collection procedures,

end each of the first enabled ones of the various structured collection procedures when the exit criteria of each of the first enabled ones of the various structured collection procedures have been met,

run automatically the master protocol with next ones of the various structured collection procedure having their entry criteria met by the exit criteria of the previous ones of the various structured collection procedures being met; and

assign a unique identifier to the each event, when the one or more adherence criteria are met, which corresponds to the each event in the structured collection procedure; and

wherein the unique identifier is not assigned when the biomarker measurement is determined by the processor as not being close enough in time to a data event request based on a prescheduled time so as to facilitate the structured collection procedure and improve the compliancy with the structured collection procedure of a management system; and

providing a microprocessor, a power source, and an indicator, the indicator connected to the processor and which can operate under the control of the processor to emit audible, tactile, or visual alerts to the individual of daily times for the biomarker measurement; and

sending a message from the blood glucose meter to a physician when the individual fails to complete one of the one or more adherence criteria, wherein a communication link between a computer of the physician and the blood glucose meter can be established upon connection via a web server.