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| Descriptive Information Fields | |||||||||
| Brief Title † | Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-Way Pagers | ||||||||
| Official Title † | 2-Way Pagers to Improve Schizophrenia Medication Adherence | ||||||||
| Brief Summary | This study will determine whether using a pager improves medication adherence in people with schizophrenia. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Percent of prescribed doses taken as assessed by the Medication Event Monitoring System (MEMS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Multidimensional Scale of Independent Functioning [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Drug Attitude Inventory [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Positive and Negative Symptom Scale (PANSS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Self Appraisal of Illness Questionnaire [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Quality of Life Interview (Short Version) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia | ||||||||
| Intervention † | Device: 2-way pager Behavioral: Treatment as usual |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 80 | ||||||||
| Start Date † | April 2006 | ||||||||
| Completion Date | March 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00392236 | ||||||||
| Organization ID | R34 MH074844 | ||||||||
| Secondary IDs †† | DAHBR 96-BHA | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | October 23, 2006 | ||||||||
| Last Updated Date | February 26, 2008 | ||||||||
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