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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH114700 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.
In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa.
The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAE + LAI | Experimental | Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customized Adherence Enhancement | Behavioral | Customized Adherence Enhancement (CAE): CAE targets key areas relevant to adherence in chronic psychotic disorders (CPD): 1.) inadequate understanding of mental disorder, 2.) lack of adequate medication-taking routines, 3.) poor communication with care providers and 4.) substance use which interferes with adherence and recovery. CAE delivered components are selected based upon findings from the ROMI and AMSQ. CAE will be delivered in approximately 8 sessions by a nurse interventionist, ideally at the same time that the long-acting injectable (LAI) is administered.The intervention is guided by a detailed manual and uses components and resources that are available in lower- and middle-income countries (LMICs). Social worker interventionists will be trained to deliver CAE-L. |
| Measure | Description | Time Frame |
|---|---|---|
| Tablets Routine Questionnaire (TRQ) | The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 20-30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications). | Change from Baseline to 6 month visit |
| Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections: | LAI injection adherence will be determined as a count of participants who received LAI injections at the appropriate time (within 7 days of scheduled time). | Baseline to 6 month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Attitude Inventory (DAI) | 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. | Baseline to 6 month visit |
| Brief Psychiatric Rating Scale (BPRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUHAS | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35086504 | Derived | Mbwambo J, Kaaya S, Lema I, Burant CJ, Magwiza C, Madundo K, Njiro G, Blixen CE, Cassidy KA, Levin JB, Sajatovic M. An interventional pilot of customized adherence enhancement combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania. BMC Psychiatry. 2022 Jan 27;22(1):62. doi: 10.1186/s12888-022-03695-8. |
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38 individuals were assessed for preliminary eligibility. 16 people were excluded, 5 were unable to contact, 2 were not interested, 3 did not meet criteria, and 6 were no-shows for screening.
22 provided informed consent initially. 2 of these people failed the oral tolerance test and 1 did not complete baseline measures.
19 participants enrolled and attended visits 1-6 and 18 attended all 7 visits.
The study setting was Muhimbili National Hospital, a 70-bed national referral hospital located in urban Dar es Salaam, Tanzania.
Patients were referred from 4 catchment zones that include 3 regional public and private hospitals and were recruited from inpatient and outpatient settings.
19 adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication demonstrating poor adherence.
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| ID | Title | Description |
|---|---|---|
| FG000 | CAE + LAI Treatment | The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
| |||||||||||||
| Week 13 Assessment |
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| Week 25 Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | CAE + LAI Treatment | The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). |
| 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 | Tablets Routine Questionnaire (TRQ) | The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 20-30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications). | Since participants stopped using oral medications once they were stable on LAI, there were only two participants remaining at 25 Week visit and therefore analysis was not done. As only 2 individuals were on concommittent oral CPD medication at 25 week follow up, mean change in TRQ was not calculated. This was just done to enter into clinical trials. | Posted | Mean | Standard Deviation | percentage of change in adherence | Change from Baseline to 6 month visit |
|
25 weeks
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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 + LAI Treatment | The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Substance use relapse and hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 participant relapsed into substance abuse and was hospitalized. This SAE was not deemed to be related to individual's participation in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tremor | Nervous system disorders | Non-systematic Assessment | Tremor |
The small sample size, single-site enrollment, and the fact that poor medication adherence was one of the inclusion criterion may make findings less generalizable to the full spectrum of patients with CPD in Tanzania. Additionally, since we did not collect data on family burden, it is not possible to make any conclusions regarding how CAE-L may impact families and communities.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaylee Sarna | Case Western Reserve University | (216) 368-3577 | kns17@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 | Jan 7, 2019 | May 14, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Survey ICF UH stamped | Apr 7, 2020 | Jun 25, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: English Qualitative Interview | Apr 7, 2020 | Jun 25, 2021 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Focus Group ICF | Apr 7, 2020 | Jun 25, 2021 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Phase 3 ICF | Apr 7, 2020 | Jun 25, 2021 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D055118 | Medication Adherence |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| C033563 | haloperidol decanoate |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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|
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| Haloperidol Decanoate | Drug | Long-acting injectable (LAI): Patients on oral haloperidol will be switched to haloperidol decanoate per manufacturer's package insert. Individuals not on antipsychotic medication at the time of screening assessment or who are on a different antipsychotic medication, will receive an oral tolerance test (OTT) consisting of up to 14 days of oral haloperidol 2-5 mg once or twice daily. If the OTT suggests good tolerability, the participant will then receive LAI (haloperidol decanoate) intramuscularly after completion of baseline assessments. Dosing of LAI will be as clinically indicated using conservative dosing to minimize drug-related adverse effects. In the CWRU studies, mean end-point dose of haloperidol decanoate was 68.0 mg, SD 21.1, Range 50-100 mg/monthly injection. It is anticipated that patients will continue on the same dose for 6 months, although dose changes will be permitted based upon clinical status. Each study participant will receive up to 8 injections during the study. |
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|
The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania. |
| Baseline to 6 month visit |
| Clinical Global Impressions (CGI) | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. | Baseline to 6 month visit |
| Social and Occupational Functioning Scale (SOFAS) | 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 6 month visit |
| Body Mass Index | Body Mass Index kg/m^2 of participants | Baseline to Month 6(week 25) |
| ESRS-A Parkinsonism | Extrapyramidal Symptoms Scale-Abbreviated version for Parkinsonism. It looks at drug-induced Parkinsonism which is made up of motor disturbances. Rigidity, tremor, reduced facial expression/speech, impaired gait/posture, postural instability, and bradykinesia. Each item is rated on a 4 point scale: 0=absent, 3=severe. The higher the value the more severe the Parkinsonism and worst outcomes. | Baseline to 6 months(25 weeks) |
| ESRS-A Dystonia | Extrapyramidal Symptoms Scale-Abbreviated version for dystonia- drug-induced dystonia is a muscle disorder in which movements are jerky or twisting. Due to the 0.00 values at baseline and 25 weeks, unable to perform t-test and get a p value so no statistical analysis section is reported for this Outcome Measure. Each item is rated on a 4 point scale: 0=absent, 3=severe with the higher numbers indicating worse dystonia and worse outcomes. | Baseline to 6 months(25 weeks) |
| ESRS-A Dyskinesia | Extrapyramidal Symptoms Scale-Abbreviated version for Dyskinesia- drug-induced dyskinesia which is repetitive and involuntary movements. Each item is rated on a 4 point scale: 0=absent, 3=severe and higher values indicate greater severity of dyskinesia and worse outcomes. | Baseline to 6 months(25 weeks) |
| ESRS-A Akathisia | Extrapyramidal Symptoms Scale-Abbreviated version for akathisia- drug-induced akathisia consists of inner restlessness and urge to move. Items are measured on a 4 value scale: 0=absent, 3=severe, and higher values indicate more severe akathisia and worse outcomes. | Baseline to 6 months(25 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Educational level | Mean | Standard Deviation | years |
|
| Employment | Count of Participants | Participants |
|
| Age of CPD(chronic psychotic disorder) onset | Mean | Standard Deviation | years |
|
| Duration of CPD(chronic psychotic disorder) | Mean | Standard Deviation | years |
|
| Number of previous hospitalizations | Mean | Standard Deviation | hospitalizations |
|
| Past physical abuse | Count of Participants | Participants |
|
| Past sexual abuse | Count of Participants | Participants |
|
| Family history of mental illness | Count of Participants | Participants |
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| Family history of substance abuse | Count of Participants | Participants |
|
| AUDIT score | AUDIT: Alcohol Use Disorders Identification Test. There are 10 questions and possible scores range from 0-40. A higher score is associated with worse outcomes for drug/alcohol dependence. Score of 0 suggests abstainer, 1-7 suggests low risk consumption, 8-14 suggests hazardous alcohol consumption, 15+ indicates alcohol dependence. | Mean | Standard Deviation | units on a scale |
|
| ASSIST score | ASSIST: Alcohol, Smoking, and Substance Involvement Screening Test. The ASSIST is an 8 item questionnaire to screen for use of drugs/substances. The ASSIST determines a risk score for each substance. Current frequency of substance use was calculated here using question 2 only. 0-4 was the scale with increasing numbers indicating more drug use frequency. Higher values are associated with worse outcomes/more frequent drug use. 0-3 is lower risk, 4-26 is moderate risk, and 27+ is high risk of dependence to drugs. | Mean | Standard Deviation | units on a scale |
|
| Self-reported Charlson Index score | Self-reported Charlson Index Score. CCI Total Score = the sum of all 10-items, where each item checked gets 1 point, except heart disease and kidney disease which get 2 points each, liver disease which gets 3 points, and cancer and HIV/AIDS which get 6 points each. CCI scores predict risk of mortality. Scores range from 0-24. A higher score is associated with increased risk of mortality. | Mean | Standard Deviation | units on a scale |
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| Body Mass Index(BMI) | Mean | Standard Deviation | kg/m^2 |
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| Past oral medication history | Count of Participants | Participants |
|
| Screening TRQ(tablets routine questionnaire) | Tablets Routine Questionnaire: self-reported proportion of missed oral medication in the last 30 days. Scores range from "0" (perfect adherence) to "100" (did not take any prescribed medication). Mean Tablet Routines Questionnaire calculated only for oral CPD medications (antipsychotics, mood stablizers, antidepressants). If more than 1 oral medication was prescribed. an average TRQ was calculated. Screening sample TRQ, N =19. | Mean | Standard Deviation | units on a scale |
|
| Baseline TRQ(tablets routine questionnaire) | Tablets Routine Questionnaire: self-reported proportion of missed oral medication in the last 30 days. Scores range from "0" (perfect adherence) to "100" (did not take any prescribed medication). Mean Tablet Routines Questionnaire calculated only for oral CPD medications (antipsychotics, mood stablizers, antidepressants). If more than 1 oral medication was prescribed. an average TRQ was calculated. Screening sample TRQ, Baseline sample TRQ, N=18 | 18 people were sampled instead of 19 in the baseline. | Mean | Standard Deviation | units on a scale |
|
The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). |
|
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| Primary | Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections: | LAI injection adherence will be determined as a count of participants who received LAI injections at the appropriate time (within 7 days of scheduled time). | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). LAI injection frequency was 100%. | Posted | Count of Participants | Participants | Baseline to 6 month visit |
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| Secondary | Drug Attitude Inventory (DAI) | 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 schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 month visit |
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| Secondary | Brief Psychiatric Rating Scale (BPRS) | The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania. | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 month visit |
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|
| Secondary | Clinical Global Impressions (CGI) | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 month visit |
|
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|
|
| Secondary | Social and Occupational Functioning Scale (SOFAS) | 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 schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 month visit |
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| Secondary | Body Mass Index | Body Mass Index kg/m^2 of participants | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to Month 6(week 25) |
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| Secondary | ESRS-A Parkinsonism | Extrapyramidal Symptoms Scale-Abbreviated version for Parkinsonism. It looks at drug-induced Parkinsonism which is made up of motor disturbances. Rigidity, tremor, reduced facial expression/speech, impaired gait/posture, postural instability, and bradykinesia. Each item is rated on a 4 point scale: 0=absent, 3=severe. The higher the value the more severe the Parkinsonism and worst outcomes. | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months(25 weeks) |
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|
| Secondary | ESRS-A Dystonia | Extrapyramidal Symptoms Scale-Abbreviated version for dystonia- drug-induced dystonia is a muscle disorder in which movements are jerky or twisting. Due to the 0.00 values at baseline and 25 weeks, unable to perform t-test and get a p value so no statistical analysis section is reported for this Outcome Measure. Each item is rated on a 4 point scale: 0=absent, 3=severe with the higher numbers indicating worse dystonia and worse outcomes. | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months(25 weeks) |
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| Secondary | ESRS-A Dyskinesia | Extrapyramidal Symptoms Scale-Abbreviated version for Dyskinesia- drug-induced dyskinesia which is repetitive and involuntary movements. Each item is rated on a 4 point scale: 0=absent, 3=severe and higher values indicate greater severity of dyskinesia and worse outcomes. | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months(25 weeks) |
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| Secondary | ESRS-A Akathisia | Extrapyramidal Symptoms Scale-Abbreviated version for akathisia- drug-induced akathisia consists of inner restlessness and urge to move. Items are measured on a 4 value scale: 0=absent, 3=severe, and higher values indicate more severe akathisia and worse outcomes. | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months(25 weeks) |
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|
| 0 |
| 19 |
| 1 |
| 19 |
| 13 |
| 19 |
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| Drowsiness | General disorders | Non-systematic Assessment | Drowsiness |
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| Blurry vision | Eye disorders | Non-systematic Assessment | Blurry vision |
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| Restlessness | General disorders | Non-systematic Assessment | Restlessness |
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| Muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Muscle pain |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |