Clinical monitoring device with time shifting capability

• US 8,533,029 B2
• Filed: 09/04/2012
• Issued: 09/10/2013
• Est. Priority Date: 04/02/2001
• Status: Expired due to Term

• Current Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Original Assignee: Invivodata Incorporated (Explorer Holdings, Inc.)
• Inventors: Hufford, Michael, Peterson, David, Paty, Jean, Shiffman, Saul, McClelland, Jonathan, O'Keefe, Kevin Dennis
• Primary Examiner(s): Maguire, Lindsay M.
• Application Number:
  US13/603,035
• Publication Number:
  US 20130006671A1
• Time in Patent Office: 371 Days
• Field of Search: 705/11
• US Class Current: 705/11
• CPC Class Codes: G06Q 10/0639 Performance analysis of employees; Performance analysis of enterprise or organisation operations
• 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 20/00 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 40/63 for local operation

Abstract

The present invention is designed to develop research protocols for clinical trials. The invention can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.

Claims

1. A method of operating a clinical monitoring device, the method comprising:

(a) collecting in the clinical monitoring device a first health data set from a subject or clinician during a first time range and a second health data set from the subject or the clinician during a second time range, at least one of the second health data set and the second time range being determined in part based on a content of the first health data set, wherein the first and second time ranges are part of a protocol, wherein the protocol is based on a trial;

(b) recording the first and second health data sets in the clinical monitoring device;

(c) including a time and date with the recorded health data sets; and

(d) initiating a time shifting mode that allows a user of the clinical monitoring device to adjust an operating date and time of the clinical monitoring device from a first event in the protocol, corresponding to a first operational state of the clinical monitoring device, relative to a second event in the protocol, corresponding to a second operational state of the clinical monitoring device, the clinical monitoring device operating at the second event in the protocol in the same manner and collecting health data from the subject or clinician in the same manner as if the clinical monitoring device had reached the second event without intervention by the user and resulting in initiation of the second operational state of the clinical monitoring device,

wherein adjustment of the operating date and time of the clinical monitoring device from the first event in the protocol to the second event in the protocol changes an operational state of the clinical monitoring device without modification to the trial.

2. The method of claim 1, wherein collecting the health data sets includes collecting diary entries.

3. The method of claim 1, wherein the collecting in the clinical monitoring device the first health data set and the second health data set includes determining the first and second time ranges that correspond to at least one of a time of day or week, and a range relative to an event.

4. The method of claim 1, wherein initiating the time shifting mode that allows the user of the clinical monitoring device to adjust the operating date and time of the clinical monitoring device includes the user adjusting the operating date and time of the clinical monitoring device by selecting an event instead of specifying an actual time.

5. The method of claim 1, wherein initiating the time shifting mode that allows the user of the clinical monitoring device to adjust the operating date and time of the clinical monitoring device includes setting the second event in the protocol to a specific event relative to a time range during which the subject or clinician is allowed to enter health data.

6. The method of claim 1, wherein initiating the time shifting mode that allows the user of the clinical monitoring device to adjust the operating date and time of the clinical monitoring device includes setting a clock of the clinical monitoring device to a specific event in a schedule of clinical treatment.

7. The method of claim 1, wherein initiating the time shifting mode that allows the user of the clinical monitoring device to adjust the operating date and time of the clinical monitoring device includes setting the second event in the protocol to a point in time selected as a result of a calculation based on health data collected prior to the second event in the protocol.

8. The method of claim 1, wherein operating the clinical monitoring device comprises providing the protocol with a plurality of decision points, and wherein the clinical monitoring device executes one or more of the decision points based on health data received from the subject or clinician.

9. The method of claim 1, wherein the collecting in the clinical monitoring device of the first health data set and the second health data set includes computer executable code for collecting at least one of a diary completed by the subject or clinician, a questionnaire completed by the subject or clinician, and a response of the subject or clinician to a clinical event.

10. The method of claim 1, wherein initiating the time shifting mode that allows the user of the clinical monitoring device to adjust the operating date and time of the clinical monitoring device includes setting the second event in the protocol to a time in the protocol when the clinical monitoring device first causes a screen to be displayed that requires a response from the subject or clinician.

11. The method of claim 1, wherein initiating the time shifting mode that allows the user of a data recording software to adjust the operating date and time of the clinical monitoring device to the second event in the protocol includes allowing the user to advance the operating date and time of the clinical monitoring device.

12. The method of claim 1, wherein initiating the time shifting mode that allows the user of a data recording software to adjust the operating date and time of the clinical monitoring device to the second event in the protocol includes allowing the user to adjust the operating date and time of the clinical monitoring device to an earlier operating date and time of the clinical monitoring device.

13. The method of claim 1, wherein the time shifting mode allows selection of the second event for use in training the user of a data recording software.

14. The method of claim 1, wherein the time shifting mode allows election of the second event for use in testing a data recording software.

15. The method of claim 1, wherein the time shifting mode automatically jumps from the first event to immediately before or at the second event.

16. The method of claim 1, wherein the clinical monitoring device is a portable electronic, device capable of displaying information to the subject and receiving input from the subject and storing the input, wherein the method further comprises accepting the input from the subject and activating a tactile alarm if the input is not correct.