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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| The Zucker Hillside Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Feedback System (DHFS) | Experimental | Ingestion Sensor, Wearable Sensor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health Feedback System | Other | The digital health offering passively collects and records medication-taking behavior and other habits of daily living |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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:
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| Name | Affiliation | Role |
|---|---|---|
| John M Kane, MD | The Zucker Hillside Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02116 | United States | ||
| Zucker Hillside Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23842023 | Result | Kane JM, Perlis RH, DiCarlo LA, Au-Yeung K, Duong J, Petrides G. First experience with a wireless system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder. J Clin Psychiatry. 2013 Jun;74(6):e533-40. doi: 10.4088/JCP.12m08222. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 28 individuals with bipolar disorder (12) or schizophrenia (16) | Posted | Mean | 95% Confidence Interval | percentage of observed ingestions | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Health Feedback System (DHFS) | DHFS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| schizoaffective disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-limited rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Nine non-serious AEs were reported by 6 subjects. All of the device-related, non serious AEs were characterized as skin irritation at the adhesive monitor placement location. The skin-related adverse events were mild in nature and self-limited. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John M. Kane MD | Zucker Hillside Hospital, Glen Oaks, NY | (718) 470-8141 | psychiatry@nshs.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| 4 weeks |
| 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 | 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| Glen Oaks |
| New York |
| 11004 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Mental Health Disorder | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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 | Not Posted | 8 weeks | Participants |
| 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. | Not Posted | 4 weeks | Participants |
| 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 | Not Posted | 4 weeks | Participants |
| 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. | Not Posted | 4 weeks | Participants |
| 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. | Not Posted | 4 weeks | Participants |
| 1 |
| 28 |
| 6 |
| 28 |
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| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |