| Primary | Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire | The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The null hypothesis is that the median difference between 6 months and baseline equals zero. | Sign test | | <.001 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Primary | Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire | The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Primary | Change in Treatment Adherence as Measured by the Morisky Scale | The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Primary | Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire | The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ) | The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Attitude as Measured by the Rating of Medication Influences (ROMI) | The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D) | The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) | The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS) | The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) | The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale | The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12) | The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12) | The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health. | Number of participants for analysis was based on all available data at the six month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D) | The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) | The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS) | The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) | The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale | The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ) | The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Attitude as Measured by the Rating of Medication Influences (ROMI) | The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Primary | Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire | The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12) | The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |
| Secondary | Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12) | The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health. | Number of participants for analysis was based on all available data at the three month time point. | Posted | | Mean | Standard Error | units on a scale | | baseline and 3 months | | | | ID | Title | Description |
|---|
| OG000 | Customized Adherence Enhancement (CAE) | Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles. |
| |