Apparatus and method for managing medication adherence

• US 9,454,645 B2
• Filed: 01/12/2014
• Issued: 09/27/2016
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: AI Cure Technologies LLC
• Original Assignee: AI Cure Technologies LLC
• Inventors: Hanina, Adam, Kessler, Gordon
• Primary Examiner(s): Nguyen, Hiep V
• Application Number:
  US14/153,042
• Publication Number:
  US 20140129253A1
• Time in Patent Office: 989 Days
• Field of Search: 705/2, 705/3
• US Class Current: 1/1
• 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 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/00 ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method of a clinical trial is provided. The system comprises a summary page providing an overview of each clinical trial participant in a graphical format, each clinical trial participant being represented by a unique clinical trial participant identifier and one or more clinical trial participant identifier modifiers applicable to modify one or more of the clinical trial participant identifiers, each modifier indicative of a different status of the particular participant identifier to which it is applied. A zoom selector is provided for zooming in on a subset of the clinical trial participant identifiers included with the summary page. Upon selection of a particular level of zoom, a corresponding amount of detailed information related to the subset of the clinical trial identifiers is provided; the detailed information including at least an indication of the level of compliance of a clinical trial participant to a prescribed clinical trial protocol represented by a corresponding clinical trial participant identifier, and further information related to any particular clinical trial participant identifier modifiers applied to any one of the clinical trial participant identifiers included within the subset.

Claims

1. A system for monitoring participant medication adherence in one or more clinical trials, comprising:

a medication adherence monitoring apparatus operable to determine adherence of one or more clinical trial participants to a predetermined medication protocol, the medication adherence monitoring apparatus comprising a camera arranged and configured to capture a video of a user performing a plurality of predetermined steps indicative of proper medication administration, and comprising a processor operable to employ automated computer vision video activity sequence recognition of one or more medication administration instances performed by each of the one or more clinical trial participants;

a computer configured to, in response to data received from the medication adherence monitoring apparatus, output to a display;

a graphical user interface comprising a summary page providing an overview of each clinical trial participant in a graphical format, each clinical trial participant being represented by a unique clinical trial participant identifier;

a plurality of clinical trial participant identifier modifiers applicable to modify one or more of the clinical trial participant identifiers in the summary page, each modifier indicative of a different status of the particular participant as represented by their identifier to which it is applied, wherein at least one modifier is indicative of a deviation in compliance with a medical protocol by a clinical trial participant as determined at least in part in accordance with the operation of the medication adherence monitoring apparatus; and

a zoom selector for zooming in on a subset of the clinical trial participant identifiers included with the summary page;

wherein the computer is further configured to;

provide a first zoom level of the summary page;

receive a user-initiated command via the graphical user interface to modify a zoom level of the zoom selector; and

responsive to receiving the command to modify the zoom level, providing a second zoom level of the summary page comprising a corresponding amount of detailed information related to the subset of the clinical trial participant identifiers that is unavailable in the first zoom level, the detailed information including at least an indication of a plurality of different methods through which medication adherence has been confirmed and an indication of at least a proportion of medication adherence confirmations that have been performed by each of the plurality of different methods, at least one of the plurality of different methods comprising automated computer vision video activity sequence recognition by the medication adherence monitoring apparatus.

2. The system of claim 1, wherein automated computer vision video activity sequence recognition by the medication adherence monitoring apparatus comprises:

determining one or more procedures for administering a prescription regimen in accordance with the clinical trial;

identifying one or more video activity sequences associated with the one or more determined procedures;

capturing video activity sequences of actual administration of such prescription regimen;

storing the captured video activity sequences to a non-transitory computer readable storage medium; and

determining in an automated manner in accordance with the captured video activity sequences, whether the clinical trial participant has properly performed the video activity sequences, and therefore followed the prescribed prescription regimen.

3. The system of claim 1, wherein the detailed information includes one or more questions from a clinical trial participant.

4. The system of claim 1, wherein the detailed information includes a status of review of instructions by the clinical trial participant represented by the corresponding clinical trial participant indicator.

5. The system of claim 1, wherein the detailed information includes a status of medical supplies of the clinical trial participant represented by the corresponding clinical trial participant indicator.

6. The system of claim 1, wherein the detailed information includes information about a medication prescribing physician associated with the clinical trial participant represented by the corresponding clinical trial participant indicator.

7. The system of claim 6, further comprising a communication system for communicating with the medication prescribing physician.

8. The system of claim 1, further comprising a communication system for communicating with one or more of the clinical trial participants.

9. A method for monitoring participant medication adherence in one or more clinical trials, comprising:

determining, by a medication adherence monitoring apparatus, adherence of one or more clinical trial participants to a predetermined medication protocol, wherein determining adherence comprises capturing, by a camera of the medication adherence monitoring apparatus, a video of a user performing a plurality of predetermined steps indicative of proper medication administration, and comprises employing, by a processor of the medication adherence monitoring apparatus, automated computer vision video activity sequence recognition of one or more medication administration instances performed by each of the one or more clinical trial participants;

outputting from a computer to a display, in response to data received from the medication adherence monitoring apparatus, a graphical user interface comprising a summary page depicting an overview of each clinical trial participant in a graphical format, each clinical trial participant being represented by a unique clinical trial participant identifier;

designating on the display one or more clinical trial participant identifier modifiers applicable to modify one or more of the clinical trial participant identifiers in the summary view, each modifier indicative of a different status of the particular participant as represented by their identifier to which it is applied, wherein at least one modifier is indicative of a deviation in compliance with a medical protocol by a clinical trial participant as determined at least in part in accordance with the operation of the medication adherence monitoring apparatus;

receiving a user-initiated command via the graphical user interface to modify a zoom level of the summary page; and

responsive to receiving the command to modify the zoom level, zooming from a first zoom level to a second zoom level, the second zoom level comprising a subset of the clinical trial participant identifiers included with the summary page; and

displaying, on the display upon zooming to the second zoom level, a corresponding amount of detailed information related to the subset of the clinical trial participant identifiers that is unavailable in the first zoom level;

the detailed information including at least an indication of a plurality of different methods through which medication adherence has been confirmed and an indication of at least a proportion of medication adherence confirmations that have been performed by each of the plurality of different methods, at least one of the plurality of different methods comprising automated computer vision video activity sequence recognition by the medication adherence monitoring apparatus.

10. The method of claim 9, further comprising receiving a command to select a particular clinical trial patient identifier;

and responsive to receiving the command to select the particular clinical trial patient identifier, displaying, on the display, a most complete set of information related thereto.

11. The method of claim 10, wherein automated computer vision video activity sequence recognition by the medication adherence monitoring apparatus comprises:

determining one or more procedures for administering a prescription regimen in accordance with the clinical trial;

identifying one or more video activity sequences associated with the one or more determined procedures;

capturing video activity sequences of actual administration of such prescription regimen;

storing the captured video activity sequences to a non-transitory computer readable storage medium; and

determining in an automated manner in accordance with the captured video activity sequences, whether the clinical trial participant has properly performed the video activity sequences, and therefore followed the prescribed prescription regimen.

12. The method of claim 9, further comprising broadcasting information related to one or more changes to a medication protocol to one or more clinical trial participants by selecting one or more of the clinical trial participant indicators from the summary screen on the display.

13. The method of claim 12, wherein the broadcasting information comprises additional video, audio or written instructions.

14. The method of claim 12, wherein the broadcasting information comprises a warning.

15. A system for monitoring medication adherence in one or more patients, the system comprising a medication adherence monitoring apparatus operable to determine adherence of one or more patients to a predetermined medication protocol, the medication adherence monitoring apparatus comprising a camera configured and arranged to capture a video of a user performing a plurality of predetermined steps indicative of proper medication administration, and comprising a processor operable to employ automated computer vision video activity sequence recognition of one or more medication administration instances performed by each of the one or more patients, the system for monitoring medication adherence further comprising a computer configured to output to a display:

a graphical user interface comprising a summary page providing an overview of each patient in a graphical format, each patient being represented by a unique patent identifier, each patient identifier able to be grouped according to one or more attributes of the patient;

a plurality of patient identifier modifiers applicable to modify one or more of the patient identifiers in the summary view, each modifier indicative of a different status of the particular patient as represented by their identifier to which it is applied, wherein at least one modifier is indicative of a deviation in compliance with a medical protocol by a patient as determined at least in part in accordance with the operation of the medication adherence monitoring apparatus; and

a zoom selector for zooming in on a subset of the patient identifiers included with the summary page

wherein the computer is further configured to;

provide a first zoom level of the summary page;

receive a user-initiated command via the graphical user interface to modify a zoom level of the zoom selector; and

responsive to receiving the command to modify the zoom level, providing a second zoom level of the summary page comprising a corresponding amount of detailed information related to the subset of the patient identifiers that is unavailable in the first zoom level, the detailed information including at least an indication of a plurality of different methods through which medication adherence has been confirmed and at least an indication of at least a proportion of medication adherence confirmations that have been performed by each of the plurality of different methods, at least one of the plurality of methods comprising a automated computer vision video activity sequence recognition by the medication adherence monitoring apparatus.

16. The system of claim 15, wherein the processor is operable to determine one or more procedures for administering a prescription regimen, identify one or more video activity sequences associated with the one or more determined procedures, capture video activity sequences of actual administration of such prescription regimen, store the captured video activity sequences to a non-transitory computer readable storage medium, and determine in an automated manner in accordance with the captured video activity sequences, whether the patient has properly performed the video activity sequences, and therefore followed the prescribed prescription regimen.

17. The system of claim 15, wherein the detailed information includes one or more questions from a patient.

18. The system of claim 15, wherein the detailed information includes a status of review of instructions by the patient represented by the corresponding patient indicator.

19. The system of claim 15, wherein the detailed information includes a status of medical supplies of the patient represented by the corresponding patient indicator.

20. The system of claim 15, wherein the detailed information includes information about a medication prescribing physician associated with the patient represented by the corresponding patient indicator.