Trial Outcomes & Findings for Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia (NCT NCT00406718)
NCT ID: NCT00406718
Last Updated: 2015-10-05
Results Overview
Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)
Results posted on
2015-10-05
Participant Flow
197 signed consents, but only 142 were randomized. 24 no longer wanted to participate, 15 were lost to follow up and could not be contacted, 11 did not meet inclusion criteria once documentation was reviewed, 2 moved out of the area and 3 individuals had family who did not want the individual to participate, leading them to withdraw consent.
Participant milestones
| Measure |
Pharm CAT
Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
|
Med-eMonitor
Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
|
Treatment as Usual
standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
47
|
|
Overall Study
COMPLETED
|
43
|
34
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
14
|
8
|
Reasons for withdrawal
| Measure |
Pharm CAT
Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
|
Med-eMonitor
Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
|
Treatment as Usual
standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
9
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
4
|
Baseline Characteristics
Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia
Baseline characteristics by cohort
| Measure |
PharmCAT
n=47 Participants
Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
|
Med-eMonitor
n=48 Participants
Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
|
Standard Treatment
n=47 Participants
Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 10.15 • n=7 Participants
|
42.0 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
42.52 years
STANDARD_DEVIATION 10.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
47 participants
n=5 Participants
|
142 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)Population: All individuals randomized who had a baseline and at least one follow-up rating
Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.
Outcome measures
| Measure |
PharmCAT
n=46 Participants
Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
|
Med-eMonitor
n=46 Participants
Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
|
Standard
n=45 Participants
Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
|
|---|---|---|---|
|
Adherence
|
91.84 Percentage of medication taken
Standard Deviation 11.07
|
88.61 Percentage of medication taken
Standard Deviation 16.07
|
72.55 Percentage of medication taken
Standard Deviation 26.84
|
PRIMARY outcome
Timeframe: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)Population: Patients with baseline and at least one follow up rating
Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes
Outcome measures
| Measure |
PharmCAT
n=46 Participants
Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
|
Med-eMonitor
n=46 Participants
Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
|
Standard
n=45 Participants
Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
|
|---|---|---|---|
|
Social and Occupational Functioning Assessment Scale (SOFAS) Scores
|
91.84 Units on a scale
Standard Deviation 11.70
|
88.61 Units on a scale
Standard Deviation 16.07
|
73.19 Units on a scale
Standard Deviation 25.66
|
SECONDARY outcome
Timeframe: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)Population: All subjects with a baseline and at least one follow up rating
Brief Psychiatric Rating Scale (BPRS) expanded version psychosis subscale, mean of items for unusual thought content, auspiciousness, conceptual disorganization, and hallucinations. Higher scores mean greater level of symptomatology. Scores vary from 1 = absent to 7 = severe
Outcome measures
| Measure |
PharmCAT
n=46 Participants
Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
|
Med-eMonitor
n=46 Participants
Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
|
Standard
n=45 Participants
Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
|
|---|---|---|---|
|
Schizophrenia Symptoms
|
2.73 units on a scale
Standard Deviation .13
|
2.75 units on a scale
Standard Deviation .13
|
2.72 units on a scale
Standard Deviation .13
|
Adverse Events
PharmCAT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Med-eMonitor
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PharmCAT
n=47 participants at risk
Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
|
Med-eMonitor
n=48 participants at risk
Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
|
Standard Treatment
n=47 participants at risk
Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
|
|---|---|---|---|
|
Psychiatric disorders
paranoia from monitor
|
0.00%
0/47 • Reported annually in IRB report patients followed only for the 10 month duration of the study.
|
2.1%
1/48 • Reported annually in IRB report patients followed only for the 10 month duration of the study.
|
0.00%
0/47 • Reported annually in IRB report patients followed only for the 10 month duration of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place