Apparatus and method for collection of protocol adherence data

A medication adherence monitoring system, comprising:

• a first storage device operable to store one or more sets of user prompts for encouraging proper performance of one or more predetermined movement sequences indicative of proper medication administration;
• a display operable to display to the patient, one or more of the one or more sets of user prompts for encouraging proper performance of the one or more predetermined movement sequences;
• a video data capture device operable to capture at least video data of the patient performing one or more of the one or more predetermined movement sequences in response to the one or more of the one or more user prompts;
• a second storage device for storing the captured video data;
• and
• a first processor operable to
• output, to the display, a first type of alert that notifies the patient it is time to administer medication,
• receive a patient medication administration initiation response following the output of the first type of alert,
• output to the display, responsive to receiving the patient medication administration initiation response, the one or more of the one or more sets of,
• receive the captured video data from the second storage device,
• automatically compare the stored captured video data to additional video data comprising video of the one or more predetermined movement sequences,
• determine, from the comparison, whether the patient has properly performed the predetermined movement sequences,
• responsive to determining, from the comparison, that the patient has not properly performed the predetermined movement sequences, output, to the display, interactive feedback to the patient and an additional one or more of the one or more sets of user prompts to further encourage proper performance of the one or more predetermined movement sequences.

A medication adherence monitoring system for use in confirming administration of medication in a clinical trial, comprising:

• a first storage device operable to store one or more sets of user prompts for encouraging proper performance of one or more predetermined movement sequences to be performed by a participant indicative of proper performance of a predefined participant clinical trial protocol for medication administration;
• a display operable to display to the participant one or more of the one or more sets of user prompts for encouraging proper performance of the one or more predetermined movement sequences;
• a video data capture device operable to capture at least video information of the participant performing one or more of the one or more predetermined movement sequences following the one or more of the one or more displayed user prompts;
• a second storage device for storing the captured video information;
• a first processor operable to
• output, to the display, a first type of alert that notifies the participant it is time to administer medication,
• receive a participant medication administration initiation response following the output of the first type of alert,
• output to the display, responsive to receiving the participant medication administration initiation response, the one or more of the one or more sets of,
• receive the stored captured video information from the second storage device,
• automatically analyze the stored captured video information to confirm whether the participant has properly performed the predetermined movement sequences, and
• responsive to confirming that the participant has not properly performed the predetermined movement sequences, output, to the display, interactive feedback to the participant and an additional one or more of the one or more sets of user prompts to further encourage proper performance of the one or more predetermined movement sequences.

A system for confirming administration of medication, the system comprising:

• an authentication apparatus for authenticating a medication manager;
• a database comprising prescription administration information for the medication;
• and
• a medication adherence monitoring apparatus, the medication adherence monitoring apparatus comprising
• a first storage device operable to store one or more sets of user prompts for encouraging proper performance of one or more predetermined movement sequences indicative of proper medication administration;
• a display operable to display to the patient, one or more of the one or more sets of user prompts for encouraging proper performance of the one or more predetermined movement sequences;
• a video data capture device operable to capture at least video data of the patient performing one or more of the one or more predetermined movement sequences in response to the one or more of the one or more user prompts;
• a second storage device for storing the captured video data;
• and
• a first processor operable to
• output, to the display, a first type of alert that notifies the patient it is time to administer medication,
• receive a patient medication administration initiation response following the output of the first type of alert,
• output to the display, responsive to receiving the patient medication administration initiation response, the one or more of the one or more sets of user prompts,
• receive the captured video data from the second storage device,
• automatically compare the stored captured video data to additional video data comprising video of the one or more predetermined movement sequences,
• determine, from the comparison, whether the patient has properly performed the predetermined movement sequences,
• responsive to determining, from the comparison, that the patient has not properly performed the predetermined movement sequences, output, to the display, interactive feedback to the patient and an additional one or more of the one or more sets of user prompts to further encourage proper performance of the one or more predetermined movement sequences.