Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Medication Adherence, Psychosocial Treatment, Cognitive Adaptation Training, Med-e Monitor, Adaptive Function
Brief summary
This study will determine the comparative effectiveness of two systems designed to improve medication adherence in people with schizophrenia.
Detailed description
Schizophrenia is a severely debilitating mental disorder. People with schizophrenia often experience unusual thoughts or perceptions, decreased pleasure in everyday life, and difficulty functioning in social situations. Antipsychotic medications have been shown to be effective in improving the symptoms of schizophrenia. Poor adherence to medication, however, leads to re-hospitalization, impedes the process of recovery, and contributes to the high costs associated with schizophrenia treatment. Studies have shown that PharmCAT, cognitive adaptive training that specifically targets medication adherence, has been effective in improving adherence and outcomes in people with schizophrenia. The Med-eMonitor™ is a new pill device that is able to alert patients when they should take medication, when they are taking the wrong medication, and when they are taking medication at the wrong time. The device can also record side effect complaints and then send stored information to treatment staff. The capabilities of the Med-eMonitor™ eliminate the need for the weekly home visits that are necessary in the PharmCAT program, and may make treatment more easily available to individuals in remote or rural settings. This study will compare the effectiveness of PharmCAT, the Med-eMonitor™, and standard treatment in improving medication adherence and treatment outcome in people with schizophrenia. Participants in this study will be randomly assigned to one of the following treatment groups: (1) PharmCAT; (2) the Med-eMonitor™; or (3) standard treatment. Participants in Group 1 will receive weekly home visits from a case manager. These visits will specifically target medication adherence. Participants in Group 2 will use the Med-eMonitor™ device. Data recorded by the device will be sent electronically to study staff. Participants in Group 3 will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function. The device will record only when medication is taken. All participants will report to the study site at study entry and Months 4, 7, and 10 for measures of symptoms, functioning, social activities, and relationships.
Interventions
BEHAVIORALMed-eMonitor
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.
BEHAVIORALPharmCAT
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.
BEHAVIORALTreatment as Usual
Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria, as determined on the basis of the Structured Clinical Interview for Diagnosis (SCID-P) * Receiving treatment with an oral atypical antipsychotic medication other than clozapine (e.g., risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, or others as they are FDA approved) * Assumes some responsibility for taking own medications * Able to provide evidence of a stable living environment (e.g., individual apartment, family home, or board and care facility) within 3 months prior to study entry and no plans to move in the next year * Intact visual and auditory ability as determined by a computerized screening battery * Ability to read at the 5th grade level or higher based upon score on the Wide Range Achievement Test (WRAT) * Able to understand and complete rating scales and neuropsychological testing * Working telephone present in the home
Exclusion criteria
* History of significant head trauma, seizure disorder, or mental retardation * Alcohol or drug abuse or dependence within 3 months prior to study entry * Currently being treated by an assertive community treatment (ACT) team * History of violence within 1 year prior to study entry * Any hospitalizations within 3 months prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 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) | Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period. |
| Social and Occupational Functioning Assessment Scale (SOFAS) Scores | 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) | Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Schizophrenia Symptoms | 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) | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PharmCAT 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. | 47 |
| 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. | 48 |
| Standard Treatment 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. | 47 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 5 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 9 | 4 |
Baseline characteristics
| Characteristic | Med-eMonitor | Standard Treatment | PharmCAT | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 47 Participants | 47 Participants | 142 Participants |
| Age, Continuous | 43.0 years STANDARD_DEVIATION 10.15 | 42.0 years STANDARD_DEVIATION 9.27 | 43.0 years STANDARD_DEVIATION 11.04 | 42.52 years STANDARD_DEVIATION 10.27 |
| Region of Enrollment United States | 48 participants | 47 participants | 47 participants | 142 participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 23 Participants | 68 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 24 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 1 / 48 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 48 | 0 / 47 |
Outcome results
Primary
Adherence
Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PharmCAT | Adherence | 91.84 Percentage of medication taken | Standard Deviation 11.07 |
| Med-eMonitor | Adherence | 88.61 Percentage of medication taken | Standard Deviation 16.07 |
| Standard | Adherence | 72.55 Percentage of medication taken | Standard Deviation 26.84 |
Primary
Social and Occupational Functioning Assessment Scale (SOFAS) Scores
Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PharmCAT | Social and Occupational Functioning Assessment Scale (SOFAS) Scores | 91.84 Units on a scale | Standard Deviation 11.7 |
| Med-eMonitor | Social and Occupational Functioning Assessment Scale (SOFAS) Scores | 88.61 Units on a scale | Standard Deviation 16.07 |
| Standard | Social and Occupational Functioning Assessment Scale (SOFAS) Scores | 73.19 Units on a scale | Standard Deviation 25.66 |
Secondary
Schizophrenia Symptoms
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PharmCAT | Schizophrenia Symptoms | 2.73 units on a scale | Standard Deviation 0.13 |
| Med-eMonitor | Schizophrenia Symptoms | 2.75 units on a scale | Standard Deviation 0.13 |
| Standard | Schizophrenia Symptoms | 2.72 units on a scale | Standard Deviation 0.13 |