Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392236
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2006-10-23
Brief Title:
Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
2-Way Pagers to Improve Schizophrenia Medication Adherence
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 doctors 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 doctors 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH074844 | NIH | None | httpsreporternihgovquickSearchR34MH074844 |