In-person vs. Remote Wellness Support
R-CAT
2 other identifiers
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
November 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2022
CompletedResults Posted
Study results publicly available
September 5, 2024
CompletedSeptember 5, 2024
August 1, 2024
2 years
August 21, 2020
April 24, 2024
August 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (2)
Self-Report Habit Index (SRHI)
Baseline to 6 months (note that repeated measures analysis examined change over time as well.
Symptomatology
Baseline to 6 months
Study Arms (2)
Cognitive Adaptation Training (CAT)
ACTIVE COMPARATORA home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.
Remote Cognitive Adaptation Training (R-CAT)
ACTIVE COMPARATORA primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Able to give informed consent.
- Between the ages of 18 and 65.
- Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder
- Receiving treatment with oral psychiatric medications.
- Have had a hospitalization or emergency department visit in the past year
- 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
- Responsible for taking their own medications
- 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
- 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
- Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months
- Have a working smart phone
- Able to understand and complete rating scales and assessments.
- Agree to home visits for intervention and to count pills and conduct assessments
You may not qualify if:
- Substance dependence within the past 2 months
- Currently being treated by an ACT team
- Documented history of violence or threatening behavior on initial assessment
- Receive home visits to assist with medication adherence
- Unable to complete baseline assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dawn Velligan, PhD
- Organization
- University of Texas Health Science Center in San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Dawn Velligan, PhD
University of Texas Health at San Antonio
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 25, 2020
Study Start
November 24, 2020
Primary Completion
November 11, 2022
Study Completion
November 11, 2022
Last Updated
September 5, 2024
Results First Posted
September 5, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
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: * The National Institute of Mental Health who is funding this study * The following collaborators at other institutions that are involved with the study: Superior Medicaid * The committee that checks the study data on an ongoing basis, to determine if the study should be stopped for any reason. * The members of the local research team * The Institutional Review Board and the Compliance Office of the University of Texas Health Science Center at San Antonio, and other groups that oversee how research studies are carried out.