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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine the posited mechanistic underpinnings of the CAE-S intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the Tablets Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary measures will include the Clinical Global Impression (CGI), functional status, quality of life and attitudes towards medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Experimental | CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use. |
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| Enhanced Treatment as Usual (eTAU) | Other | To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customized Adherence Enhancement for Schizophrenia (CAE-S) | Behavioral | 6-session series spaced out over approximately 6-10 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks | 12 weeks | |
| Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks | The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia | 12 weeks |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Customized Adherence Enhancement for Schizophrenia (CAE-S) | CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use. Customized Adherence Enhancement for Schizophrenia (CAE-S): 6-session series spaced out over approximately 6-10 weeks |
| FG001 | Enhanced Treatment as Usual (eTAU) | To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have. Enhanced Treatment as Usual (eTAU): eTAU participants will view a pre-taped series of 6 videos |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Customized Adherence Enhancement for Schizophrenia (CAE-S) | CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use. Customized Adherence Enhancement for Schizophrenia (CAE-S): 6-session series spaced out over approximately 6-10 weeks |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks | Posted | Mean | Standard Deviation | Number of sessions attended | 12 weeks |
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12 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 | Customized Adherence Enhancement for Schizophrenia (CAE-S) | CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use. Customized Adherence Enhancement for Schizophrenia (CAE-S): 6-session series spaced out over approximately 6-10 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martha Sajatovic, MD | University Hospitals Cleveland Medical Center | 216-844-2808 | martha.sajatovic@UHHospitals.org |
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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 2, 2024 | Sep 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Enhanced Treatment as Usual (eTAU) | Other | eTAU participants will view a pre-taped series of 6 videos |
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| Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks |
The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence. |
| 12 weeks |
| Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks | The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence. | 12 weeks |
| Change in eCAP Use in the Past Week at 12 Weeks | Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription. | 12 weeks |
| BG001 | Enhanced Treatment as Usual (eTAU) | To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have. Enhanced Treatment as Usual (eTAU): eTAU participants will view a pre-taped series of 6 videos |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Martial Status | Count of Participants | Participants |
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| Years of Education | Mean | Standard Deviation | years |
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| Employment Status | Count of Participants | Participants |
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| Health Insurance Status | Participants may have more than 1 type of insurance, which is why the totals add up to more than the number of participants in a study arm. | Count of Participants | Participants |
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| Age at schizophrenia diagnosis | Mean | Standard Deviation | years |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| History of physical abuse | Count of Participants | Participants |
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| History of sexual abuse | Count of Participants | Participants |
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| PANSS total score | The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia. | Mean | Standard Deviation | units on a scale |
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| Hospitalizations (lifetime) | There were very few participants who had been hospitalized for substance use (4 participants overall - 3 in the CAE-S group and 1 in the eTAU group), so the decision was made to calculate mean number of hospitalizations using only those who had a hospitalization for substance use. | Mean | Standard Deviation | Number of hospitalizations |
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| Health resource use, past 3 months | Mean | Standard Deviation | number of events |
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| Primary | Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks | Only 16 of the 19 participants randomized to CAE-S provided data on satisfaction with CAE-S | Posted | Number | percentage of CAE-S participants | 12 weeks |
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| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks | The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia | Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Secondary | Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks | The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence. | Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data | Posted | Mean | Standard Deviation | Percentage of days with missed doses | 12 weeks |
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| Secondary | Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks | The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence. | Only 16 participants in the CAE-S group and only 13 participants in the eTAU group provided Week 12 data | Posted | Mean | Standard Deviation | Percentage of days with missed doses | 12 weeks |
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| Secondary | Change in eCAP Use in the Past Week at 12 Weeks | Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription. | We only have eCAP data on 11 participants in the CAE-S group and 8 participants in the eTAU group | Posted | Mean | Standard Deviation | Percentage of missed doses | 12 weeks |
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| 0 |
| 19 |
| 2 |
| 19 |
| 0 |
| 19 |
| EG001 | Enhanced Treatment as Usual (eTAU) | To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have. Enhanced Treatment as Usual (eTAU): eTAU participants will view a pre-taped series of 6 videos | 0 | 17 | 0 | 17 | 0 | 17 |
| Hospitalization due to diabetes complications | Endocrine disorders | Non-systematic Assessment |
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| Hospitalization due to renal complications | Renal and urinary disorders | Non-systematic Assessment |
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| Hospitalization due to psychiatric symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Unknown or Not Reported |
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