Bipolar Disorder, Schizophrenia
Conditions
Keywords
Adherence, Bipolar disorder, Cellular phone, Cloud computing, Computers, Computers, handheld, Digital health, Digital health feedback system, Ingestion Sensor, Medication adherence, Medication non-adherence, Medication nonadherence, Mobile phone, Mobile health, Patient adherence, Patient non-adherence, Patient nonadherence, Schizophrenia, Telehealth, Telemedicine, Telenursing, Wearable sensor
Brief summary
Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Hypothesis: Using a digital health feedback system to characterize medication-taking behavior and activities of daily living is safe and tolerable in appropriately selected patients with bipolar disorder and schizophrenia.
Detailed description
In this 4-week observational study conducted between May 2010 and May 2011 at 2 US academic clinical study sites, 12 adults with bipolar disorder and 16 adults with schizophrenia (all diagnosed according to DSM-IV criteria) utilized a digital health feedback system (DHFS). All subjects were on a stable regimen of oral medication. The DHFS utilized a digital tablet, consisting of an ingestion sensor that was embedded in a tablet containing nonpharmacologic excipients, which subjects coingested with their regularly prescribed medication. The primary study objective was to compare the accuracy of DHFS in confirming digital tablet ingestion versus a method of directly observed ingestion; secondary aims included characterization of adherence and physiologic measures longitudinally in these cohorts.
Interventions
The digital health offering passively collects and records medication-taking behavior and other habits of daily living
Sponsors
Massachusetts General Hospital
The Zucker Hillside Hospital
Proteus Digital Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 and ≤ 65 years of age * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, by Structured Clinical Interview using DSM-IV SCID-I/P1, for either: i. Bipolar disorder I, II, or Not Otherwise Specified (NOS), or ii. Schizophrenia or schizoaffective disorder * Clinical global impression scale-severity (CGI-S) of 3 or below * Currently on a stable regimen of oral antimanic or antipsychotic medication for at least 3 months * No anticipation to change or titrate the regimen in the next 28 days * Willingness to adhere to study procedures * Capacity to provide informed consent
Exclusion criteria
* Pregnancy, or women of child bearing potential who are not using a medically accepted means of contraception * Serious suicide or homicide risk, as assessed by evaluating clinician * Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease * DSM-IV diagnoses or symptoms of substance use disorders, active within the last 60 days * A score of 3 or higher on the suspiciousness/paranoia item of the Brief Psychiatric Rating Scale (BPRS) * Acute, clinically significant gastrointestinal symptoms, such as nausea, vomiting, abdominal pain, diarrhea, melena, or hematochezia * History of significant gastrointestinal disease or major gastrointestinal surgery * Clinical instability of any kind that, in the investigator's opinion, could preclude safe participation in the study * Known allergies that could preclude safe participation in the study * Current presence of an electronically active implanted medical device * Participation in another medical device study, or on any investigational drug or device within the last 30 days * Inability to obtain consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Detection Accuracy | 4 weeks | Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Safety | 8 weeks | Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Taking and Scheduling Adherence | 4 weeks | Characterize, using summary (descriptive) statistics, medication-taking behavior in free-living environment. Taking adherence defined as the number of ingestion sensors detected by the DHFS in the free-living environment, divided by the prescribed (planned) number of ingestions. Scheduling adherence defined as number of ingestion sensors detected by the DHFS within a ± 2-hour time window around the prescribed (planned) dosing time, divided by the total number of ingestion sensors detected by the DHFS. |
| Biometrics | 4 weeks | Characterize, using summary (descriptive) statistics, heart rate and rest/activity patterns in a free-living environment. Activity defined as the number of hours per day with recorded a recorded step rate ≥ 60 steps per minute |
| Usability | 4 weeks | Characterize, using summary (descriptive) statistics, the use of the digital health feedback system and its components by patients, caregivers, and healthcare providers. Use captured utilizing numeric scores collected from a standardized instrument, focusing on overall comfort and ease of DHFS use. |
| User Experience | 4 weeks | Feedback and suggestions from patients, caregivers, and healthcare providers regarding system metrics and summary presentations of medication-taking, biometrics, and activities of daily living. Feedback includes free text and descriptive statistics summarizing numeric scores collected from a standardized instrument focusing on overall satisfaction with the DHFS and its components. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Digital Health Feedback System (DHFS) Ingestion Sensor, Wearable Sensor
Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Digital Health Feedback System (DHFS) |
|---|---|
| Age, Customized | 42.8 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 Participants |
| Type of Mental Health Disorder Bipolar Disorder | 12 Participants |
| Type of Mental Health Disorder Schizophrenia | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 28 |
| serious Total, serious adverse events | 1 / 28 |
Outcome results
Primary
Positive Detection Accuracy
Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.
Time frame: 4 weeks
Population: 28 individuals with bipolar disorder (12) or schizophrenia (16)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital Health Feedback System (DHFS) | Positive Detection Accuracy | 94 percentage of observed ingestions |
Secondary
System Safety
Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study
Time frame: 8 weeks
Other Pre-specified
Biometrics
Characterize, using summary (descriptive) statistics, heart rate and rest/activity patterns in a free-living environment. Activity defined as the number of hours per day with recorded a recorded step rate ≥ 60 steps per minute
Time frame: 4 weeks
Other Pre-specified
Taking and Scheduling Adherence
Characterize, using summary (descriptive) statistics, medication-taking behavior in free-living environment. Taking adherence defined as the number of ingestion sensors detected by the DHFS in the free-living environment, divided by the prescribed (planned) number of ingestions. Scheduling adherence defined as number of ingestion sensors detected by the DHFS within a ± 2-hour time window around the prescribed (planned) dosing time, divided by the total number of ingestion sensors detected by the DHFS.
Time frame: 4 weeks
Other Pre-specified
Usability
Characterize, using summary (descriptive) statistics, the use of the digital health feedback system and its components by patients, caregivers, and healthcare providers. Use captured utilizing numeric scores collected from a standardized instrument, focusing on overall comfort and ease of DHFS use.
Time frame: 4 weeks
Other Pre-specified
User Experience
Feedback and suggestions from patients, caregivers, and healthcare providers regarding system metrics and summary presentations of medication-taking, biometrics, and activities of daily living. Feedback includes free text and descriptive statistics summarizing numeric scores collected from a standardized instrument focusing on overall satisfaction with the DHFS and its components.
Time frame: 4 weeks