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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH074844 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine whether using a pager improves medication adherence in people with schizophrenia.
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. Many people with schizophrenia have difficulty with remembering their scheduled doctor's appointments and with taking their medication on time because of their mental illness. Many approved medications for schizophrenia must be taken several times a day and side effects such as drowsiness, dizziness, and even weight gain can deter a person from consistently taking their medication on time. Therefore, this study will determine whether a 2-way pager will help people with schizophrenia to remember their doctor's appointments and to take their medication on time.
Participants in this open-label study will first complete several written tests to assess skills such as memory, attention, and problem solving. Participants will also be asked questions regarding their current symptoms and medication regimen. Participants will then be randomly assigned to receive either treatment as usual or treatment as usual and a 2-way pager for 6 months. Participants who receive a 2-way pager will attend approximately four information sessions. During these sessions, participants will learn how to program the pager and use a specially designed medication bottle cap that will record the number of bottle openings and the date and time of each opening. At designated times, the pager will vibrate or beep, alerting participants to take their medication or attend a scheduled appointment. All participants will meet weekly with a staff member for the first month and then once a month for the remaining 5 months to complete several brief questionnaires on pager use, assess medication adherence, and discuss any symptoms experienced within the past week or month. Participants will be required to bring their medication to each meeting to ensure compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Participants will receive treatment as usual and a 2-way pager for 6 months |
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| B | Active Comparator | Participants will receive treatment as usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-way pager | Device | Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS) | Estimated percent of prescribed medication taken during month 6 of the study was calculated using all available data sources (MEMS supplemented by subject interview and pill counts). | Measured at Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Delbert G. Robinson, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
The open label phase 1 of the study was designed to refine the pager intervention . Seventeen subjects completed baseline assessments, pager training and phase 1 study procedures. Data presented under Participant Flow are for the group of subjects who participated in the the randomized phase 2 of the study.
The study had 2 phases. Phase 1 was devoted to testing the Electronically Assisted Medication Adherence (EAMA) system. All subjects received the EAMA system during Phase 1. Phase 2 was a randomized trial comparing EAMA with treatment as usual. The main focus of this report is Phase 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pager Group | Participants will receive treatment as usual and a 2-way pager for 6 months 2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking. |
| FG001 | Treatment as Usual | Participants will receive treatment as usual Treatment as usual means that study participation does not affect the treatment participants receive in any way. Participants receive whatever treatment they and the clinical team decide upon. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pager Group | Participants will receive treatment as usual and a 2-way pager for 6 months 2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS) | Estimated percent of prescribed medication taken during month 6 of the study was calculated using all available data sources (MEMS supplemented by subject interview and pill counts). | Posted | Mean | Standard Deviation | percentage of prescribed medication take | Measured at Month 6 |
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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 | Pager Group | Participants will receive treatment as usual and a 2-way pager for 6 months 2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Delbert Robinson, M.D. | Feinstein Institute for Medical Research | 718 470-8195 | drobinso@nshs.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Behavioral | Participants will receive treatment as usual. |
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| Treatment as Usual |
Participants will receive treatment as usual Treatment as usual: Participants will receive treatment as usual. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants will receive treatment as usual Treatment as usual: Participants will receive treatment as usual. |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Treatment as Usual | Participants will receive treatment as usual Treatment as usual: Participants will receive treatment as usual. | 0 | 18 | 0 | 18 |
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