Schizophrenia Clinical Trial
— R-CATOfficial title:
In-person vs. Remote Wellness Support (Study Sub-title: Remote Cognitive Adaptation Training to Improve Medication Follow Through in Managed Care (R-CAT))
Verified date | June 2023 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | November 11, 2022 |
Est. primary completion date | November 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Able to give informed consent. 2. Between the ages of 18 and 65. 3. Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder 4. Receiving treatment with oral psychiatric medications. 5. Have had a hospitalization or emergency department visit in the past year 6. Have a Medication Possession Ratio (MPR) based upon electronic refill data below 80% at least 1 of the past 4 quarters with at least 1 psychiatric medication 7. Responsible for taking their own medications 8. Report on telephone prescreen call with researcher team that they have missed at least 2 doses of medication in the past 3 weeks, that they are willing to take medication and would like remote assistance to take medication more regularly 9. Report on telephone prescreen call with research team that they have a stable living environment (individual apartment, family home, board and care facility) within the last three months and no plans to move in the next year 10. Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months 11. Have a working smart phone 12. Able to understand and complete rating scales and assessments. 13. Agree to home visits for intervention and to count pills and conduct assessments Exclusion Criteria: 1. Substance dependence within the past 2 months 2. Currently being treated by an ACT team 3. Documented history of violence or threatening behavior on initial assessment 4. Receive home visits to assist with medication adherence 5. Unable to complete baseline assessments |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center - Department of Psychiatry | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptance of intervention | Proportion of subjects who dropped out of treatment | Baseline to 6 months | |
Primary | Medication Adherence | 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. | Baseline to 6 months | |
Secondary | Cost of treatment | Cost to include mail, supports, provider time in visit, preparation time and mileage | Baseline to 6 months | |
Secondary | Pill count percent | Medication possession ratio from prescription refill data | Baseline to 6 months | |
Secondary | Self-Report Habit Index (SRHI) | 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. | Baseline and at month 2, 4 and 6 | |
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. A total score reflects an overall level of symptomology, with 164, being the maximum score, with the most symptoms present. | Baseline and at month 2, 4 and 6 | |
Secondary | Functional Outcome | 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. | Baseline and month 2, 4 and 6 |
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