Peters-Strickland T, Pestreich L, Hatch A, Rohatagi S, Baker RA, Docherty JP, Markovtsova L, Raja P, Weiden PJ, Walling DP. Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole. Neuropsychiatr Dis Treat. 2016 Oct 11;12:2587-2594. eCollection 2016. PubMed PMID: 27785036; PubMed Central PMCID: PMC5067053.
Masand P, Han C, Pae CU. Will the Proteus sensor enhance adherence to aripiprazole or other antipsychotics? Expert Rev Neurother. 2017 Apr;17(4):319-321. PubMed PMID: 28132567.
Masand P, Han C, Pae CU. Will the Proteus sensor enhance adherence to aripiprazole or other antipsychotics? Expert Rev Neurother. 2017 Apr;17(4):319-321. PubMed PMID: 28132567.
Background
Non-adherence is a big problem in persons with schizophrenia. Patient self-report and clinician impression have been shown to underestimate non-adherence. Can digital technology help to better monitor adherence?
On November 13, 2017, the United States Food and Drug Administration (FDA) approved a new product containing aripiprazole with a sensor with the brand name Abilify MyCite.
The product contains aripiprazole along with a sensor called an Ingestible Event Marker (IEM). When the pill is ingested by the patient, the sensor sends a signal to a patch that the patient wears on the left lower ribcage. This signal is then transmitted from the sensor on the ribcage to an app on a digital device (either a smartphone or a tablet). Together, this is called a Digital medicine system (DMS). The patient can give permission to caregivers and clinicians to access this information.
The product is approved by the FDA for the same indications as the drug (brand name Abilify).
The paper discussed here evaluated this Digital Management System. The aim was to evaluate the usability and acceptability of the system.
Methods
This was a multicenter, phase IIa, open-label study. Patients were not blinded and there was no control group.
Adult patients with schizophrenia were enrolled and treated with aripiprazole with sensor.
After enrollment, patients first entered a training phase consisting of three visits at one-week intervals.
This was followed by a five-week “independent phase”.
Results
Sixty-seven patients with schizophrenia were enrolled in the study and 73% completed the study.
The mean age of the participants was about 47 years. The majority of them were male (75%) and black (76%).
Importantly, 70% of the patients were rated to be mildly ill.
Participants were asked to apply the wearable sensor, change it about once a week, and to pair it each time with the digital device. By the end of the study, 55% of the participants were able to do these tasks independently and another 27% were able to do them with minimal assistance.
The participants wore the wearable sensor for a median of 78% of the time in the trial.
At the last visit, 78% of patients reported being “somewhat satisfied,” “satisfied,” or “extremely satisfied” with the digital management system. But “somewhat satisfied” is a rating that may be easily achieved. Unfortunately, the percentage of patients who reported being “satisfied” or “extremely satisfied” was not reported in the paper.
Conclusions
The authors concluded that a high proportion of the participants were able to use the digital management system and reported satisfaction with it.
They also concluded that these data support the potential utility of the Digital Management System in clinical practice.
Clinical Commentary
On the one hand, it is exciting and interesting to see this innovation in treatment. I am hopeful that in the future, significant improvements and innovations will occur in relation to digital technology that could help monitor adherence.
But with regard to this particular study, we must note that the participants were not particularly ill at the time of the study. Also, they were being paid to participate in the study. Lastly, the study lasted for only eight weeks. Yet, it was not uncommon for patients to not use the wearable sensor or to discontinue participation in the study (27% of those enrolled).
My concern is that the system may work the least in those who need it the most—patients who are more severely ill, who have worse insight, and who are more disorganized.
An Editorial about the potential utility of this sensor technology (Masand et al., 2017) noted several limitations of the study and of the technology:
- It will be difficult for the clinician to convince patients who are paranoid that the Digital Management System is not monitoring them in other ways—their thoughts, actions, etc.
- Managing the privacy issues around the collection and storage of personal health data on digital devices (smartphones, tablets) will be challenging.
- Using the Digital Management System is time-intensive
- The system may help to identify non-adherence, but doesn’t help to assess the reasons for it.
In addition to these concerns, it should also be noted that there is no data to suggest that use of the Digital Management System will achieve its intended goal of improving adherence to the medication.
Non-adherence is a big problem in persons with schizophrenia. Patient self-report and clinician impression have been shown to underestimate non-adherence. Can digital technology help to better monitor adherence?
On November 13, 2017, the United States Food and Drug Administration (FDA) approved a new product containing aripiprazole with a sensor with the brand name Abilify MyCite.
The product contains aripiprazole along with a sensor called an Ingestible Event Marker (IEM). When the pill is ingested by the patient, the sensor sends a signal to a patch that the patient wears on the left lower ribcage. This signal is then transmitted from the sensor on the ribcage to an app on a digital device (either a smartphone or a tablet). Together, this is called a Digital medicine system (DMS). The patient can give permission to caregivers and clinicians to access this information.
The product is approved by the FDA for the same indications as the drug (brand name Abilify).
The paper discussed here evaluated this Digital Management System. The aim was to evaluate the usability and acceptability of the system.
Methods
This was a multicenter, phase IIa, open-label study. Patients were not blinded and there was no control group.
Adult patients with schizophrenia were enrolled and treated with aripiprazole with sensor.
After enrollment, patients first entered a training phase consisting of three visits at one-week intervals.
This was followed by a five-week “independent phase”.
Results
Sixty-seven patients with schizophrenia were enrolled in the study and 73% completed the study.
The mean age of the participants was about 47 years. The majority of them were male (75%) and black (76%).
Importantly, 70% of the patients were rated to be mildly ill.
Participants were asked to apply the wearable sensor, change it about once a week, and to pair it each time with the digital device. By the end of the study, 55% of the participants were able to do these tasks independently and another 27% were able to do them with minimal assistance.
The participants wore the wearable sensor for a median of 78% of the time in the trial.
At the last visit, 78% of patients reported being “somewhat satisfied,” “satisfied,” or “extremely satisfied” with the digital management system. But “somewhat satisfied” is a rating that may be easily achieved. Unfortunately, the percentage of patients who reported being “satisfied” or “extremely satisfied” was not reported in the paper.
Conclusions
The authors concluded that a high proportion of the participants were able to use the digital management system and reported satisfaction with it.
They also concluded that these data support the potential utility of the Digital Management System in clinical practice.
Clinical Commentary
On the one hand, it is exciting and interesting to see this innovation in treatment. I am hopeful that in the future, significant improvements and innovations will occur in relation to digital technology that could help monitor adherence.
But with regard to this particular study, we must note that the participants were not particularly ill at the time of the study. Also, they were being paid to participate in the study. Lastly, the study lasted for only eight weeks. Yet, it was not uncommon for patients to not use the wearable sensor or to discontinue participation in the study (27% of those enrolled).
My concern is that the system may work the least in those who need it the most—patients who are more severely ill, who have worse insight, and who are more disorganized.
An Editorial about the potential utility of this sensor technology (Masand et al., 2017) noted several limitations of the study and of the technology:
- It will be difficult for the clinician to convince patients who are paranoid that the Digital Management System is not monitoring them in other ways—their thoughts, actions, etc.
- Managing the privacy issues around the collection and storage of personal health data on digital devices (smartphones, tablets) will be challenging.
- Using the Digital Management System is time-intensive
- The system may help to identify non-adherence, but doesn’t help to assess the reasons for it.
In addition to these concerns, it should also be noted that there is no data to suggest that use of the Digital Management System will achieve its intended goal of improving adherence to the medication.
