The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
Poor adherence to medication is a well-recognized problem in psychiatric patients. Although a variety of treatment models have been developed to improve management of patients in general and medication adherence in particular, poor medication adherence remains a major barrier to achieving optimal health. The MIND1 System includes a drug-device combination, a patch, and application software to convey level of activity and rest and to mark events through the act of ingestion. The purpose of this open-label study is to determine the usability of the Medical Information Device #1 (MIND1) System in adults with schizophrenia. Approximately 32 subjects with schizophrenia, between 18 and 65 years of age (inclusive) who are currently prescribed and stabilized on oral aripiprazole, will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.
Unnamed facility
Cerritos, California, United States
Unnamed facility
Garden Grove, California, United States
Unnamed facility
Oceanside, California, United States
Unnamed facility
Atlanta, Georgia, United States
Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)
Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.
Time frame: Baseline to Week 8
Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.
Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.
Time frame: Baseline to Week 8
Proportion of Time During the Study Period When Participants Wear Their Patches
Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.
Time frame: Baseline to Week 8
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Unnamed facility
Chicago, Illinois, United States
Unnamed facility
St Louis, Missouri, United States