Trial Outcomes & Findings for Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers (NCT NCT00392236)
NCT ID: NCT00392236
Last Updated: 2017-10-25
Results Overview
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).
COMPLETED
NA
55 participants
Measured at Month 6
2017-10-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers
Baseline characteristics by cohort
| Measure |
Pager Group
n=20 Participants
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.
|
Treatment as Usual
n=18 Participants
Participants will receive treatment as usual
Treatment as usual: Participants will receive treatment as usual.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 years
n=5 Participants
|
40.9 years
n=7 Participants
|
40.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6Estimated 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).
Outcome measures
| Measure |
Pager Group
n=8 Participants
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.
|
Treatment as Usual
n=12 Participants
Participants will receive treatment as usual
Treatment as usual: Participants will receive treatment as usual.
|
|---|---|---|
|
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
|
79.0 percentage of prescribed medication take
Standard Deviation 18.5
|
Adverse Events
Pager Group
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Delbert Robinson, M.D.
Feinstein Institute for Medical Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place