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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
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This is a prospective study using customized adherence enhancement (CAE) and long-acting injectable (LAI) antipsychotic in 30 individuals with bipolar disorder (BD) at risk for treatment non-adherence. The CAE approach is expected to improve treatment adherence, as well as improve BD symptoms, functioning and treatment attitudes among subjects with bipolar disorder.
Oral Abilify (aripiprazole) is effective in the treatment of patients with BD when prescribed as an acute anti-manic agent and for the maintenance treatment of bipolar disorder. Abilify Maintena is an intramuscular (IM) depot formulation of oral aripiprazole (Abilify). Abilify Maintena appears to be as effective as standard oral Abilify and may maximize patient adherence. Recent clinical trials suggest that Abilify Maintena is effective for the treatment of patients with BD.
Customized Adherence Enhancement (CAE) is a brief behavioral intervention that improves adherence approximately 30% more than an educational control in adults with BD. The CAE program is a brief, practical intervention consisting of a series of up to four psychosocial treatment modules based upon an adult's unique adherence barriers: 1) Psychoeducation on BD Medications; 2) Communication with Providers; 3) Strategies to Enhance Medication Routines; and 4) Targeting Substance Use Problems with Modified Motivational Enhancement Therapy. Multiple studies conducted by these investigators has shown that CAE is effective in in treating poorly adherent BD adults.
In addition, studies by these investigators have shown that combining LAI + CAE dramatically improves adherence, symptoms and functional outcomes in people with schizophrenia and schizoaffective disorder. In summary, LAI can maximize medication adherence, while CAE addresses individual barriers to sustained adherence and behavioral change. Combining LAI + CAE improves adherence, symptoms and functioning in high-risk people with primary psychotic disorders. The proposed project will test the efficacy of combining Abilify Maintena with CAE to help improve outcomes in poorly adherent patients with BD. Pilot data suggest that adherence with concomitantly prescribed psychotropic drugs improves with LAI + CAE. The findings have particular relevance to BD because many BD patients are on concomitant oral psychotropic drugs in addition to antipsychotic. Thus, it is expected that combining CAE with LAI will lead to a "halo effect" in that these BD patients will engage in their own care more broadly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Noncompliance | Experimental | Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abilify Maintena | Drug | Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tablets Routine Questionnaire (TRQ, Past Week) | Treatment non-adherence is measured as a percentage of medications not taken within the past week at time of assessment. The minimum score is 0% and the maximum score is 100%. A higher score implies poorer treatment adherence. | Screen to Week 24 |
| Change in Tablets Routine Questionnaire (TRQ, Past Month) | Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence. | Screen to Week 24 |
| LAI Injection Adherence | LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time). | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Brief Psychiatric Rating Scale (BPRS) Score | The BPRS measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition. | Baseline to Week 24 |
| Change in Young Mania Rating Scale (YMRS) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34534421 | Derived | Sajatovic M, Levin JB, Ramirez LF, Cassidy KA, McNamara N, Fuentes-Casiano E, Wilson B, Appling D, S FB. Long-Acting Injectable Antipsychotic Medication Plus Customized Adherence Enhancement in Poor Adherence Patients With Bipolar Disorder. Prim Care Companion CNS Disord. 2021 Sep 16;23(5):20m02888. doi: 10.4088/PCC.20m02888. |
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. Individuals were recruited from an academic medical center and via outreach to community settings including community mental health clinics (CMHCs). Enrolled participants had self-reported adherence problems as identified by the TRQ (≥20% missed BD medications in past week or past month), a screening Brief Psychiatric Rating Scale15 score ≥36, willingness to take LAI, and were in treatment at a CMHC or other clinical setting.
Participants were adults ≥ age 18 with Type 1 or Type 2 BD.
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| ID | Title | Description |
|---|---|---|
| FG000 | CAE-L | Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist. Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 Assessment (Baseline) |
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| Visit 2 Assessment |
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| Visit 3 Assessment |
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| Visit 4 Assessment |
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| Visit 5 Assessment |
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| Visit 6 Assessment |
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| Visit 7 Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | CAE-L | Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist. Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Tablets Routine Questionnaire (TRQ, Past Week) | Treatment non-adherence is measured as a percentage of medications not taken within the past week at time of assessment. The minimum score is 0% and the maximum score is 100%. A higher score implies poorer treatment adherence. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | percentage of missed BD medications | Screen to Week 24 |
|
Safety evaluations at baseline & Week 24 included basic laboratory evaluations (comprehensive metabolic panel, lipid profile, complete blood count (CBC) with differential & pregnancy testing).EKGs at baseline & Weeks 4 & 24. Side effects, vital signs & weight assessed at each clinical visit &standardized measures of extrapyramidal symptoms i.e.Simpson Angus Scale (SAS)Barnes Akathisia Scale(BAS) Abnormal Involuntary Movement Scale(AIMS) &Extrapyramidal Symptoms Scale-Abbreviated version(ESRS-A).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAE-L | Subjects enrolled in the study will receive both Abilify Miantena and the Customized Adherence Enhancement (CAE) intervention Abilify Maintena: Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist. Customized Adherence Enhancement (CAE): CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain or reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
This study had a number of limitations including small sample, non-controlled design, and single-site setting. An additional limitation is that adherence was based upon self-report, which has potential to under-count missed medication. The improvement in adherence behaviors immediately after screen (and before CAE was administered) may possibly reflect a Hawthorne effect which could have obscured improvement in CAE-related change.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy Yala, MPH | Case Western Reserve University and University Hospitals Cleveland Medical Center | 216-368-0783 | jxy790@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2017 | Jan 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Customized Adherence Enhancement (CAE) | Behavioral | CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers). |
|
The YMRS measures symptoms of mania. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. |
| Screen to Week 24 |
| Change in Montgomery Asberg Rating Scale (MADRS) Score | The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | Screen to Week 24 |
| Change in Clinical Global Impressions (CGI) Score | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. | Screen to Week 24 |
| Change in Drug Attitude Inventory (DAI) Score | DAI-10 scoring ranges from -10 to +10 with a total score >0 indicating a positive attitude toward psychiatric medications and a total score of <0 indicating a negative attitude toward psychiatric medications | Screen to Week 24 |
| Change in Attitude Towards Medication Questionnaire (AMSQ) Score | A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizers. The AMSQ is used to measure attitudes towards medications. The scale contains 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Responses which suggest positive attitudes towards medications are scored "0", while responses which suggest negative attitudes towards medications are scored "1". The items scores are added for a total score which is reported, with the minimum total score of 0 and maximum total score of 19. Higher scores on each subscale represent more negative attitudes toward mood stabilizers. | Screen to Week 24 |
| Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score | The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning. | Baseline to Week 24 |
| Change in Global Assessment of Functioning (GAF) Score | The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning. | Baseline to Week 24 |
| Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score | The OBQ assess knowledge of BD management. Total score rangers from 0-80, with a higher score indicative of better knowledge of bipolar mood management. | Screen to Week 24 |
| Change in The Self-Report Habit Index (SRHI) Score | The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits. | Screen to Week 24 |
| Change in Communication Styles Scale Score | The Communication Styles Scale is a measure of the impact of physician communication style on medication beliefs and adherence behavior. Total scores range from 0-27 where the higher score indicates a more initial collaborative communication style. | Screen to Week 24 |
| Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score | The SOCRATES measures motivation to reduce the use of substances. The minimum score is 10 and the maximum score is 50. A higher score indicates a higher desire to reduce drinking. | Screen to Week 24 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Mean Years of Education Attained | Mean | Standard Deviation | years |
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| Occupation Status | Count of Participants | Participants |
|
| Number of Participants Who Live Alone | Count of Participants | Participants |
|
| Age at Bipolar onset | Mean | Standard Deviation | years |
|
| Duration of bipolar illness | Mean | Standard Deviation | years |
|
| Number of Participants With Current Substance Use Problems | Non-alcohol Substance Use Disorder from the past 12 months derived from the Mini-International Neuropsychiatric Interview (MINI) diagnostic interview for the major psychiatric disorders in DSM-III-R, DSM-IV and DSM-5 and ICD-10. | Count of Participants | Participants |
|
| Mean lifetime psychiatric hospitalizations | Mean | Standard Deviation | hospitalizations |
|
| Mean lifetime substance abuse hospitalizations | Mean | Standard Deviation | hospitalizations |
|
| Number of Participants With History of Physical Abuse | Count of Participants | Participants |
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| Number of Participants With History of Sexual Abuse | Count of Participants | Participants |
|
| Number of Participants With Family history of Mental Illness | Count of Participants | Participants |
|
| Number of Participants With Family history of Substance Abuse | Count of Participants | Participants |
|
|
|
|
| Primary | Change in Tablets Routine Questionnaire (TRQ, Past Month) | Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | percentage of missed BD medications | Screen to Week 24 |
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|
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| Primary | LAI Injection Adherence | LAI injection adherence will be determined as a proportion of LAI injections received at the appropriate time (within 7 days of scheduled time). | Posted | Mean | Standard Deviation | percentage of adherence | Baseline to Week 24 |
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|
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| Secondary | Change in the Brief Psychiatric Rating Scale (BPRS) Score | The BPRS measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 24 |
|
|
|
|
| Secondary | Change in Young Mania Rating Scale (YMRS) Score | The YMRS measures symptoms of mania. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
|
|
|
|
| Secondary | Change in Montgomery Asberg Rating Scale (MADRS) Score | The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
|
|
|
|
| Secondary | Change in Clinical Global Impressions (CGI) Score | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
|
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|
| Secondary | Change in Drug Attitude Inventory (DAI) Score | DAI-10 scoring ranges from -10 to +10 with a total score >0 indicating a positive attitude toward psychiatric medications and a total score of <0 indicating a negative attitude toward psychiatric medications | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
|
|
|
|
| Secondary | Change in Attitude Towards Medication Questionnaire (AMSQ) Score | A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizers. The AMSQ is used to measure attitudes towards medications. The scale contains 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Responses which suggest positive attitudes towards medications are scored "0", while responses which suggest negative attitudes towards medications are scored "1". The items scores are added for a total score which is reported, with the minimum total score of 0 and maximum total score of 19. Higher scores on each subscale represent more negative attitudes toward mood stabilizers. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
|
|
|
|
| Secondary | Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score | The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 24 |
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|
|
| Secondary | Change in Global Assessment of Functioning (GAF) Score | The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 24 |
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|
| Secondary | Change in Oxford Bipolar Knowledge Questionnaires (OBQ) Score | The OBQ assess knowledge of BD management. Total score rangers from 0-80, with a higher score indicative of better knowledge of bipolar mood management. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
|
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|
|
| Secondary | Change in The Self-Report Habit Index (SRHI) Score | The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
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|
| Secondary | Change in Communication Styles Scale Score | The Communication Styles Scale is a measure of the impact of physician communication style on medication beliefs and adherence behavior. Total scores range from 0-27 where the higher score indicates a more initial collaborative communication style. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
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| Secondary | Change in Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) Score | The SOCRATES measures motivation to reduce the use of substances. The minimum score is 10 and the maximum score is 50. A higher score indicates a higher desire to reduce drinking. | Poorly adherent patients with bipolar disorder who received long-acting injectable antipsychotic medication and a customized adherence enhancement intervention (CAE). Descriptive statistics (means and standard deviations or counts and percentages) were generated for all outcomes measures using complete cases. | Posted | Mean | Standard Deviation | score on a scale | Screen to Week 24 |
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 23 |
| 30 |
| Drowsiness | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Sexual dysfunction | Reproductive system and breast disorders | Systematic Assessment |
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| Drooling | General disorders | Systematic Assessment |
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| Muscle Movement complaints | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
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| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Week 24 |
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| We compared the repeated measure outcome across 2 time-points (difference between baseline & week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis. | Wilcoxon (Mann-Whitney) | 0.63 | Mean Difference (Final Values) | -3.2 | 2-Sided | 95 | Other |
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| Week 24 |
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| We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed. | Wilcoxon (Mann-Whitney) | <0.001 | Mean Difference (Final Values) | -5.8 | 2-Sided | 95 | Other |
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| Week 24 |
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| We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed. | Wilcoxon (Mann-Whitney) | 0.003 | Mean Difference (Final Values) | -8.1 | 2-Sided | 95 | Other | We compared the repeated measure outcome across 2 time-points (difference between baseline & week 24) to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis. |
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| Week 24 |
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We compared for the primary and secondary outcomes across two time-points: difference between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.
| Wilcoxon (Mann-Whitney) |
| <0.001 |
| Mean Difference (Final Values) |
| -1.3 |
| 2-Sided |
| 95 |
| Other |
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