Schizophrenia
Conditions
Keywords
Schizoaffective Disorder
Brief summary
This study will determine whether using a pager improves medication adherence in people with schizophrenia.
Detailed description
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.
Interventions
DEVICE2-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.
BEHAVIORALTreatment as usual
Participants will receive treatment as usual.
Sponsors
National Institute of Mental Health (NIMH)
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder * Admitted to the Zucker Hillside Hospital for exacerbation of illness * Speaks English
Exclusion criteria
* Presence of severe visual or motor impairments * Mental retardation * Neurologic disorder that may impact functioning such as seizures or vascular, neoplastic, traumatic, or infectious disorders affecting the brain * Prescribed a psychotropic drug in depot form * After hospital discharge, a living or treatment situation that includes dispensing of full medication regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS) | Measured at Month 6 | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Treatment as Usual Participants will receive treatment as usual
Treatment as usual: Participants will receive treatment as usual. | 18 |
| Total | 38 |
Baseline characteristics
| Characteristic | Total | Pager Group | Treatment as Usual |
|---|---|---|---|
| Age, Continuous | 40.2 years | 40.0 years | 40.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 18 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 9 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 38 participants | 20 participants | 18 participants |
| Sex: Female, Male Female | 16 Participants | 9 Participants | 7 Participants |
| Sex: Female, Male Male | 22 Participants | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 |
Outcome results
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).
Time frame: Measured at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pager Group | Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS) | 51.7 percentage of prescribed medication take | Standard Deviation 46.7 |
| Treatment as Usual | Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS) | 79.0 percentage of prescribed medication take | Standard Deviation 18.5 |
p-value: 0.083ANOVA