In-person vs. Remote Wellness Support (R-CAT)
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|ClinicalTrials.gov Identifier: NCT04526067|
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major Bipolar Disorder Schizo Affective Disorder Schizophrenia||Behavioral: CAT Behavioral: R-CAT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized parallel design|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||In-person vs. Remote Wellness Support (Study Sub-title: Remote Cognitive Adaptation Training to Improve Medication Follow Through in Managed Care (R-CAT))|
|Actual Study Start Date :||November 24, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Cognitive Adaptation Training (CAT)
A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.
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.
Other Name: Cognitive Adaptation Training
Active Comparator: Remote Cognitive Adaptation Training (R-CAT)
A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.
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.
Other Name: Remote Cognitive Adaptation Training
- Acceptance of intervention [ Time Frame: Baseline to 6 months ]Proportion of subjects who dropped out of treatment
- Medication Adherence [ Time Frame: Baseline to 6 months ]Adherence percent is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period X100. Monthly checks will be performed.
- Cost of treatment [ Time Frame: Baseline to 6 months ]Cost to include mail, supports, provider time in visit, preparation time and mileage
- Pill count percent [ Time Frame: Baseline to 6 months ]Medication possession ratio from prescription refill data
- Self-Report Habit Index (SRHI) [ Time Frame: Baseline and at month 2, 4 and 6 ]A 12-item scale assessing three proposed characteristics of habit;1) automaticity , 2) frequency, and 3) relevance to self-identity. Four items of this scale, items 2,3,5 and 8 represent the Self-Reported Behavioral Automaticity Index (SRBAI). Lower scores indicate greater habit strength and greater automaticity. A mean Habit score will be computed using the entire scale.
- Symptomatology [ Time Frame: Baseline and at month 2, 4 and 6 ]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. A total score reflects an overall level of symptomology, with 164, being the maximum score, with the most symptoms present.
- Functional Outcome [ Time Frame: Baseline and month 2, 4 and 6 ]Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).70 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526067
|Contact: Dawn Velligan, PhDfirstname.lastname@example.org|
|Contact: Feiyu Li, PhD||210-567-5594||LiF4@uthscsa.edu|
|Principal Investigator:||Dawn Velligan, PhD||University of Texas Health at San Antonio|