Method and apparatus for verification of clinical trial adherence

• US 8,731,961 B2
• Filed: 07/26/2012
• Issued: 05/20/2014
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: AI Cure Technologies LLC
• Original Assignee: AI CURE Technologies Incorporated
• Inventors: Hanina, Adam, Kessler, Gordon
• Primary Examiner(s): Sereboff, Neal
• Assistant Examiner(s): COUPE, ANITA YVONNE
• Application Number:
  US13/558,380
• Publication Number:
  US 20120310671A1
• Time in Patent Office: 663 Days
• Field of Search: 705 2- 3
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06T 7/0012 Biomedical image inspection
• CPC Class Codes: G06V 20/48 Matching video sequences
• CPC Class Codes: G06V 40/20 Movements or behaviour, e.g. gesture recognition recognition of facial expressions G06V40/16
• 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 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

Abstract

A system and method of confirming administration of medication in a clinical trial is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen in accordance with the clinical trial, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.

Claims

1. A method of confirming administration of medication in a clinical trial, comprising the steps of:

identifying a particular medication prescription regimen in accordance with the clinical trial;

predefining one or more identifiable gestures indicative of ingestion of the medication in accordance with the medication prescription regimen for the clinical trial;

providing on a display of a local device one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

capturing video activity sequences by the local device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication by a video capture device;

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

comparing the stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication by a computer processor of the local device;

determining differences between the stored video activity sequences and the predefined one or more gestures indicative of ingestion of the medication by the computer processor of the local device, indicating proper ingestion of the medication has failed;

providing on the display of the local device, in real time in response to the determined differences, one or more further instruction prompts for further directing current performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

capturing second video activity sequences by the local device of actual medication ingestion following the one or more further instruction prompts by the video capture device;

storing the second captured video activity sequences to the non-transitory computer readable storage medium of the local device;

comparing the second stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication by a computer processor of the local device; and

determining there are no differences between the second stored video activity sequences and the predefined one or more gestures indicative of ingestion of the medication by the computer processor of the local device.

2. The method of claim 1, wherein the prescription regimen is provided by a clinical trial manager.

3. The method of claim 1, wherein the prescription regimen and predefined one or more identifiable gestures indicative of ingestion of the medication are retrieved from a medical database.

4. The method of claim 1, further comprising the step of performing a statistical analysis of differences determined in the comparing step at a remote server location.

5. The method of claim 1, further comprising the steps of:

retrieving medical history information of a patient to receive the administered medication subject to the clinical trial; and

confirming that the administered medication is safe for the patient.

6. The method of claim 1, further comprising the steps of:

before capturing the video activity sequences by the local device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication, determining the identity of a particular medication to be used in such ingestion; and

issuing a warning if it is determined by the computer processor that the determined identity is not the medication associated with the upcoming prescription regimen.

7. The method of claim 1, further comprising the steps of:

capturing video activity sequences by the local device of actual medication ingestion following the one or more instruction prompts directing proper performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication during multiple instances of administration;

transmitting the captured video activity sequences of actual medication ingestion of the medication during multiple instances of administration from the local device to a remote server location;

further analyzing the captured video activity sequences by the computer processor associated with the remote server location by comparing each of the captured video activity sequences to the predefined one or more gestures indicative of ingestion of the medication to determine differences therebetween, thereby automatically determining by the computer processor associated with the remote server location that one or more additional predefined one or more gestures indicative of proper medication ingestion have been improperly performed across one or more of the multiple instances of administration including ingestion; and

providing an analysis of adherence to a particular prescription regimen in accordance with the determination of the multiple instances of administration.

8. The method of claim 7, further comprising the step of providing additional instructions directing performance of the one or more predefined gestures indicative of proper ingestion of the medication to a medication administrator in accordance with the provided analysis.

9. The method of claim 1, wherein the notice further comprises contact to a clinical trial manager.

10. The method of claim 1, wherein the notice comprises additional instructions via the display of the local device to a patient receiving the medication according to the one or more procedures of the clinical trial.

22. The method of claim 1, further comprising the steps of:

transmitting the stored captured video activity sequences to a remote server location;

storing the transmitted captured video activity sequences to a to a non-transitory computer readable storage medium associated with the remote server location; and

further analyzing the stored video activity sequences at the remote server location by a computer processor associated with the remote server location, thereby automatically determining by the computer processor associated with the remote server location that following one or more of the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication has failed.

11. A system for confirming administration of medication in a clinical trial, comprising:

an authentication apparatus for authenticating a clinical trial manager;

an input device for receiving information identifying a particular medication prescription regimen from the authenticated clinical trial manager;

a storage device storing prescription administration information associated with the identified medication prescription regimen subject to the clinical trial, a predefined set of one or more identifiable gestures indicative of proper ingestion of medication in accordance with which the prescription regimen is to be administered, and one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

a video capture device for providing on an associated output device the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

a processor locally associated with the video capture device configured to perform the steps of;

capturing video activity sequences with the video capture device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

storing the captured video sequences to a storage medium locally associated with the video capture device;

comparing the stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication;

determining by the processor that the stored captured video sequences are different from the one or more predefined identifiable gestures indicative of ingestion of the medication, indicating proper ingestion of the medication has failed;

causing the output device associated with the video capture device to provide, in response to the determined differences in real time, one or more further instruction prompts for further directing current performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

capturing second video activity sequences with the video capture device of actual medication ingestion following the further instruction prompts;

storing the second captured video sequences to a storage medium locally associated with the video capture device;

comparing the stored second video activity sequences to the predefined one or more gestures indicative of ingestion of the medication; and

determining by the processor that the stored second captured video sequences are different from the one or more predefined identifiable gestures indicative of ingestion of the medication, indicating proper ingestion of the medication was successful.

12. The system of claim 11, wherein the information stored on the storage device may be modified by the authenticated clinical trial manager.

13. The system of claim 11, wherein the video capture device is further adapted to capture images of a particular medication to allow identification thereof.

23. The system of claim 11, wherein the output device is further configured to provide a notice if differences are determined by the processor that may improve future administration of the prescription regimen in the clinical trial.

14. A method of confirming administration ingestion of medication in a clinical trial, comprising the steps of:

authenticating a prescribing clinical trial manager;

receiving information identifying a particular medication ingestion regimen from the authenticated clinical trial manager;

modifying the medication ingestion regimen, if necessary, by the authenticated clinical trial manager;

providing on a display of a local device one or more instruction prompts directing performance of one or more predefined identifiable gestures comprising visual indicia indicative of proper ingestion of the medication;

capturing appropriate visual indicia by the local device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

storing the captured visual indicia to a non-transitory computer readable storage medium of the local device;

comparing by a computer processor associated with the local device the captured indicia for determining confirmation of medication ingestion to the one or more predefined identifiable gestures indicative of proper ingestion of the medication;

determining differences between the captured indicia and the predefined identifiable gestures;

providing, in real time in response to one or more determined differences a notice via the display of the local device, one or more further instruction prompts for further directing current performance of the one or more predefined identifiable gestures indicative of proper medication ingestion;

capturing appropriate second visual indicia by the local device of actual medication ingestion following the one or more further instruction prompts;

storing the captured second visual indicia to a non-transitory computer readable storage medium of the local device;

comparing by a computer processor associated with the local device the captured second visual indicia for determining confirmation of medication ingestion to the one or more predefined identifiable gestures indicative of proper ingestion of the medication; and

determining there are no differences between the captured indicia and the predefined identifiable gestures.

15. The method of claim 14, wherein the indicia for determining confirmation of medication ingestion comprises one or more video activity sequences.

16. The method of claim 15, wherein the indicia for determining confirmation of medication ingestion comprises an additional alternative method.

17. The method of claim 14, further comprising the steps of:

capturing visual indicia of activity of a patient before medication ingestion by the video capture device; and

providing a reminder to the patient at least in part in accordance with the captured visual indicia before medication ingestion.

18. The method of claim 14, further comprising the step of capturing visual indicia of activity of a patient by the video capture device before medication ingestion, wherein the captured visual indicia before medication administration comprises evidence of patient consent.

19. The method of claim 14, further comprising the steps of:

capturing visual indicia of activity of a patient by the video capture device after medication ingestion;

providing notification to a medical service provider of the activity; and

modifying at least one aspect of a prescription regimen in accordance with the captured visual indicia after medication ingestion.

20. The method of claim 19, wherein the captured visual indicia after medication ingestion comprises an adverse reaction to the medication.

21. The method of claim 14, further comprising the step of determining payments to a patient in a clinical trial based upon their level of compliance to the medication ingestion regimen in the clinical trial.

24. The method of claim 14, further comprising the step of providing a notice via an alternative communication network if differences are determined.