R-CAT: In-person vs. Remote Wellness Support

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT04526067
Collaborator
National Institute of Mental Health (NIMH) (NIH)
200
1
2
48.2
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CAT
  • Behavioral: R-CAT
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized parallel designRandomized 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.
Primary Purpose:
Treatment
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 :
Nov 24, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Acceptance of intervention [Baseline to 6 months]

      Proportion of subjects who dropped out of treatment

    2. Medication Adherence [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.

    Secondary Outcome Measures

    1. Cost of treatment [Baseline to 6 months]

      Cost to include mail, supports, provider time in visit, preparation time and mileage

    2. Pill count percent [Baseline to 6 months]

      Medication possession ratio from prescription refill data

    3. Self-Report Habit Index (SRHI) [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.

    4. Symptomatology [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.

    5. Functional Outcome [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Health Science Center - Department of Psychiatry San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • National Institute of Mental Health (NIMH)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT04526067
    Other Study ID Numbers:
    • HSC20200525H
    • 1R56MH123797
    First Posted:
    Aug 25, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The University of Texas Health Science Center at San Antonio
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022