Structured Tailoring

• US 20110145747A1
• Filed: 06/18/2010
• Published: 06/16/2011
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wong, Daniel, Galley, Paul J., Soni, Abhishek S., Greenburg, Alan, Reinke, Robert E., Brassington, Glenn, Hasker, David, Weinert, Stefan, Porsch, Ulrich
• Granted Patent: US 10,456,036 B2
• Time in Patent Office: Days
• US Class Current: 715/771
• 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 structured collection procedure of an individual which helps the individual change a current behavior to a target behavior, said method comprising:

providing a structured collection procedure and program instructions; and

executing the program instructions on a device which cause a processor of the device 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 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 at some unknown time;

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

end automatically the structured collection procedure upon the one or more exit criteria being met at some unknown time.

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 successfully 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.

63. 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.

26. A system for performing a structured collection procedure of an individual which helps the individual change a current behavior to a target behavior, said system comprising:

memory;

a processor connected to the memory; and

program instructions which when executed by the processor causes the processor 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 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 at some unknown time;

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

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

end automatically the structured collection procedure upon the one or more exit criteria being met at some unknown time.

27. A method of structured tailoring which assists an individual in addressing a health related behavior, said method comprising:

providing 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 health related 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

executing the program instructions on an electronic device which cause a processor of the device to;

use the entry criteria of each of the various structured collection procedures to determine 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, and

run 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.

28. The method according to claim 27 wherein the entry criteria of a sub-protocol comprises at least one of an exit criterion of another sub-protocol and a further entry criterion.

29. The method according to claim 28 wherein the program instructions further cause the processor to check preferences of the individual as the further entry criterion to determine which of the various structured collection procedures is first enabled in the master protocol.

30. The method according to claim 28 wherein the program instructions further cause the processor to use calculated skills of the individual as the further entry criteria for one or more of the various structured collection procedures.

31. The method according to claim 28 wherein the program instructions further cause the processor to use calculated skills of the individual as the further entry criterion for one or more of the various structured collection procedures, wherein each of the one or more of the various structured collection procedures having the entry criteria based on the calculated skill has a different skill level which must be met or exceeded in order to met the entry criteria.

32. The method according to claim 27 wherein one or more of the various structured collection procedures further comprises adherence criteria, and wherein the program instructions further cause the processor to check the adherence criteria of the structured collection procedures enabled in the master protocol and change which ones of the various structured collection are enabled in the master protocol when the adherence criteria are not met.

33. The method according to claim 27 wherein the next ones of the various structured collection procedure are automatically run by the processor when their entry criteria are met by the exit criteria of the previous ones of the various structured collection procedures being met.

34. The method according to claim 27 wherein the program instructions further cause the processor to use calculated skills of the individual as the exit criteria for one or more of the various structured collection procedures.

35. The method according to claim 27 wherein the program instructions further cause the processor to use calculated skills of the individual as the exit criteria for one or more of the various structured collection procedures, wherein each of the one or more of the various structured collection procedures having the exit criteria based on the calculated skill has a different skill level which must be met or exceeded in order to met the exit criteria.

36. The method according to claim 27 wherein the exit criterion for one or more of the various structured collection procedures stops their associated structured collection procedure to avoid non-reasonable data input if at least one of an acceptance criterion and an adherence criterion is not met.

37. The method according to claim 36 wherein the adherence criterion is calculated based on the data related to the behavior of the user and the acceptance criterion is calculated based on data related to the health condition of the user.

38. The method according to claim 36 wherein at least one of the acceptance criterion and the adherence criterion is calculated based on a single data point or a number of data points.

39. The method according to claim 36 wherein the exit criterion of a not met acceptance criterion and/or adherence criterion causes the master protocol to run with next ones of the various structured collection procedure having their entry criteria met by that exit criterion and after meeting an exit criterion of that next ones of the various structured collection procedure starting a new protocol or going back to the previous protocol with the exit criterion of a not met acceptance criterion and/or adherence criterion.

40. The method according to claim 27 wherein after the exit criterion is met for one or more of the structured collection procedures, the program instructions further cause the processor to provide automatically one of a learning tool and a trouble shooting guide before starting the next ones of the structured collection procedures.

41. The method according to claim 27 wherein the program instructions further cause the processor to present recommended actions and to require active confirmation by the individual for each of the recommended actions.

42. The method according to claim 41 wherein the device further comprises a user interface in communication with the processor and the active confirmation by the individual is via the user interface.

43. The method according to claim 41 wherein after the active confirmation by the individual, the program instructions further cause the processor to present automatically one of a web page, or web page link which offers the user selective information with respect to each one of the recommended actions that was confirmed.

44. The method according to claim 43 wherein the selective information comprises addresses of restaurants located near the individual, sport activities located near the individual, group of people with similar interests located near the individual, training courses located near the individual, or combinations thereof.

45. A method of assisting an individual in changing a health related behavior, said method comprising:

requesting on an electronic device a data input of data related to a health condition of a user;

calculating a medical need based on that data;

calculating a recommended health related behavior change based on the medical need which will lead to an improved health condition of the user;

requesting on an electronic device a data input of data related to preferences of the individual regarding events to be accomplished in order to change the health related behavior;

providing a structured collection procedure based the calculated health related behavior change whereby the structured collection procedure is adapted based on entered ones of the preferences of the individual; and

executing program instructions on the electronic device which cause a processor of the device to initiate the adapted structured collection procedure which takes the individual preferences of the user into account.

46. The method according to claim 45 wherein the requesting on the electronic device is via providing a catalogue of questions to the individual.

47. The method according to claim 46 wherein the structured collection procedure is based on answers to the catalogue questions.

48. The method according to claim 45 wherein the adapted structured collection procedure comprises of at least one of a learning tool and a trouble shooting guide.

49. The method according to claim 45 further comprising requesting a data input of data related to the behavior of the user in the past.

50. The method according to claim 49 further comprising comparing the data related to the behavior of the user in the past with the data related to the preferences of the individual and calculating based on that comparison the willingness of the individual to do events not indicated as a preference by the individual.

51. The method according to claim 49 wherein a willingness of the individual is calculated by applying a pattern recognition of the data related to the behavior of the user in the past.

52. The method according to claim 45 further comprising requesting intervention preferences from the individual.

53. The method according to claim 52 further comprising assessing whether an appropriate level of intervention has been entered by the individual based on associated risk of non-adherence to the structured collection procedure.

54. The method according to claim 52 wherein if the appropriate level of intervention has not been entered by the individual, said method further comprises presenting for selection appropriate levels of intervention for the associated risk of non-adherence to the structured collection procedure.

55. The method according to claim 52 wherein if the appropriate level of intervention has not been entered by the individual, said method further comprises having the device select automatically the appropriate level of intervention for the associated risk of non-adherence to the structured collection procedure.

56. A method of assisting an individual in changing a health related behavior, said method comprising:

providing on an electronic device a skill calculation module which calculates the skills of an individual based on a data input of data related to the behavior of the user;

a structured collection procedure which addresses the health related behavior and comprises an entry criterion having a skill level;

receiving on an electronic device a data input of data from the individual related to the behavior of the individual;

calculating the skill of the individual based on the received input; and

permitting the individual access to the structured collection procedure on the electronic device if the entry criteria are met by the calculated skill of the individual meeting or exceeding the skill level.

57. The method according to claim 56 further comprises the device providing training based on the calculated skill of the individual.

58. The method according to claim 57 wherein the structured collection procedure further comprises exit criteria having a skill level, and said method further comprises having the device end the structured collection procedure if calculated skill of the individual after the training meets the exit criteria by the calculated skill of the individual meeting or exceeding the skill level of the exit criteria.

59. The method according to claim 58 further comprising the device automatically initiating another structured collection procedure having a higher skill level upon meeting the exit criteria.

60. The method according to claim 56 wherein the received input is pair testing data, and the calculated skill is based on comparing an estimation values with measured values provided in the pair testing data.

61. The method according to claim 56 wherein the device calculates the skill level of the individual based on input selected from adherence to structured collection procedure after initiation, adherence of one or more previous initiated structured collection procedures, status of a disease of the individual, a classification of the health related behavior, a self-reported skill level, and combinations thereof.

62. A method for performing a structured collection procedure of an individual which helps the individual change a current behavior to a target behavior, the method comprising:

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

executing the program instructions on a device which cause a processor of the device 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 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 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, and

run 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.