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| ID | Type | Description | Link |
|---|---|---|---|
| 1R56MH123797 | 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 study team will use components of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to compare Cognitive Adaptation Training (CAT) to Remotely delivered Cognitive Adaptation Training (R-CAT) 1-9 within a managed care organization (MCO), targeting members with serious mental illness (SMI) needing assistance with the regular taking of medication.
Individuals choosing or assigned to R-CAT will continue treatment as usual with their health care team and R-CAT will be added. R-CAT is a remotely delivered version of CAT focused on medication adherence using a series of manual-driven compensatory strategies and environmental supports (signs, checklists, electronic cueing devices) based upon a streamlined assessment of executive function impairment and barriers to habit formation including forgetfulness, difficulties in problem-solving, disorganization, apathy or amotivation, disinhibition. and home environment. Initial R-CAT goals are to 1) ensure that medications listed as prescribed are available 2) to assess current cognitive, behavioral and environmental facilitators and barriers to habit-formation 3) to set up customized CAT supports to address the barriers and use facilitators to build habits to take medication. Rare home visits may occur if issues cannot be resolved remotely. Based upon the pilot, the study team don't anticipate any more than 5-10% of individuals to need face-to-face visits. No one had home visits as part of the pilot intervention. A structured R-CAT treatment note with places for pictures of CAT interventions is used for home visits. Support and reminder calls use a brief checklist modified from the Healthy Habits Program to address issues in use of supports, placement of supports and habit formation. Examples of CAT interventions to promote taking medication regularly appear above. All home visits and phone calls will be audio-taped (with consent) for quality assurance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Adaptation Training (CAT) | Active Comparator | A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions. |
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| Remote Cognitive Adaptation Training (R-CAT) | Active Comparator | A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAT | Behavioral | An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment | Proportion of subjects who dropped out of treatment | Baseline to 6 months |
| Medication Adherence | Adherence proportion is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period. Monthly checks will be performed. | Baseline to 6 months |
| Functional Outcome | Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).The SOFAS rates functioning on a scale from 0 to 100 based upon all the data collected in the assessment. Higher scores reflect better functional outcome. The value reported is the the 6 month value minus the baseline value> | Baseline to 6 months note that repeated measures analysis was also used |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Report Habit Index (SRHI) | A 36-item scale assessing three types of habit taking medication, following a schedule or calendar, and grooming (specifically brushing teeth. 12 items assessed each behavior; The SRHI looks at 1) automaticity , 2) frequency, and 3) relevance to self-identity for each behavior. There are 12 items for each sub-scale scored 1-7 (total possible range is 12-84 for each of the 3 scales). A total Habit score will be computed by calculating the mean of the 3 sub-scales to give a value between 12 and 84. Lower mean scores indicate greater habit strength. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Velligan, PhD | University of Texas Health at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center - Department of Psychiatry | San Antonio | Texas | 78229 | United States |
Because this is a research study, we will be unable keep your PHI completely confidential. We may share your health information with people and groups involved in overseeing this research study including:
Data may be shared with individuals or groups overseeing this project for reporting purposes throughout the study life and after study completion, unidentified participant data will be shared at the time of publication.
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Participants were 56 members of a large Managed Medicaid program in Texas
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| ID | Title | Description |
|---|---|---|
| FG000 | R-CAT | While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly. |
| FG001 | CAT Cognitive Adaptation Training | While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Adaptation Training (CAT) | A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions. CAT: An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits. |
| 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 | Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment | Proportion of subjects who dropped out of treatment | examined descriptive statistics for proportion of drop outs by group | Posted | Count of Participants | Participants | Baseline to 6 months |
|
Baseline to 6 months
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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 | R-CAT | While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly. |
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Not a a randomized trial. Due to the pandemic we were unable to compare groups choosing R-CAT/CAT versus those randomized. We did not get our desired number of participants. Also, some CAT in person treatment had to be conducted outside due to pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Velligan, PhD | University of Texas Health Science Center in San Antonio | 210-567-5508 | velligand@uthscsa.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 | Nov 9, 2020 | May 21, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2020 | Jun 14, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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Randomized parallel design
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Those with no preference for CAT or R-CAT will be Randomized, 1:1 done by statistician who has no patient contact through a random allocation program. If blinds are broken accidentally, new raters can be assigned, but blinds are kept by having raters and pill counters unaware of treatment group or study design.
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| R-CAT | Behavioral | An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits. |
|
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| Baseline to 6 months (note that repeated measures analysis examined change over time as well. |
| Symptomatology | Change in symptoms assess by a trained rater using the Brief Psychiatric Rating Scale-Expanded Version (BPRS-E). The scale is used to rate the subjects using 24 items, each to be rated in a 7-point scale of severity ranging from NA (not assessed), then 1-7, with 7 being the most severe. The possible range of scores is from 1 to 168 with a total score reflects an overall level of symptomology, with 168, being the maximum score, with the most symptoms present. The value reported is the 6 month value minus the baseline value. | Baseline to 6 months |
| BG001 | Remote Cognitive Adaptation Training (R-CAT) | A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions. R-CAT: An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Social and Occupational Functioning Scale score | The Social and Occupational Functioning Assessment Scale (SOFAS) is a rating scale that measures a patient's current functioning on a scale of 0 to 100, with lower scores indicating lower functioning. The SOFAS is based on a clinician's judgment of a patient's functioning in four areas: Socially useful activities, Personal and social relationships, Self-care, and Disturbing and aggressive behaviors. | Mean | Standard Deviation | units on a scale |
|
| OG001 | CAT Cognitive Adaptation Training | While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization. |
|
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| Primary | Medication Adherence | Adherence proportion is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period. Monthly checks will be performed. | IIT population with baseline and at least 1 follow up | Posted | Mean | Standard Error | proportion of pills taken | Baseline to 6 months |
|
|
|
| Primary | Functional Outcome | Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).The SOFAS rates functioning on a scale from 0 to 100 based upon all the data collected in the assessment. Higher scores reflect better functional outcome. The value reported is the the 6 month value minus the baseline value> | ITT population with at least a baseline and one follow-up assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months note that repeated measures analysis was also used |
|
|
|
| Secondary | Self-Report Habit Index (SRHI) | A 36-item scale assessing three types of habit taking medication, following a schedule or calendar, and grooming (specifically brushing teeth. 12 items assessed each behavior; The SRHI looks at 1) automaticity , 2) frequency, and 3) relevance to self-identity for each behavior. There are 12 items for each sub-scale scored 1-7 (total possible range is 12-84 for each of the 3 scales). A total Habit score will be computed by calculating the mean of the 3 sub-scales to give a value between 12 and 84. Lower mean scores indicate greater habit strength. | IIT analysis of all with baseline and at least 1 follow up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months (note that repeated measures analysis examined change over time as well. |
|
|
|
| Secondary | Symptomatology | Change in symptoms assess by a trained rater using the Brief Psychiatric Rating Scale-Expanded Version (BPRS-E). The scale is used to rate the subjects using 24 items, each to be rated in a 7-point scale of severity ranging from NA (not assessed), then 1-7, with 7 being the most severe. The possible range of scores is from 1 to 168 with a total score reflects an overall level of symptomology, with 168, being the maximum score, with the most symptoms present. The value reported is the 6 month value minus the baseline value. | ITT sample with baseline and at least one follow up. Also conducted repeated measures analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | CAT Cognitive Adaptation Training | While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D019967 |
| Schizophrenia Spectrum and Other Psychotic Disorders |