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

July 20, 2023 updated by: Dawn Velligan, The University of Texas Health Science Center at San Antonio

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
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
Time Frame: Baseline to 6 months
Proportion of subjects who dropped out of treatment
Baseline to 6 months
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.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of treatment
Time Frame: Baseline to 6 months
Cost to include mail, supports, provider time in visit, preparation time and mileage
Baseline to 6 months
Pill count percent
Time Frame: Baseline to 6 months
Medication possession ratio from prescription refill data
Baseline to 6 months
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.
Baseline and at month 2, 4 and 6
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.
Baseline and at month 2, 4 and 6
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.
Baseline and month 2, 4 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dawn Velligan, PhD, University of Texas Health at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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