In-person vs. Remote Wellness Support (R-CAT)

In-person vs. Remote Wellness Support (Study Sub-title: Remote Cognitive Adaptation Training to Improve Medication Follow Through in Managed Care (R-CAT))

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Schizo Affective Disorder
• Intervention / Treatment: Behavioral: CAT; Behavioral: R-CAT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center - Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Adaptation Training (CAT); A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.	Behavioral: 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.; Other Names: 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.	Behavioral: 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.; Other Names: Remote Cognitive Adaptation Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Dawn Velligan, PhD, University of Texas Health at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Serious mental illness
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Mood Disorders; Depressive Disorder, Major
• Other Study ID Numbers: HSC20200525H; 1R56MH123797 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No