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

Primary Purpose

Depressive Disorder, Major, Bipolar Disorder, Schizo Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAT
R-CAT
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Serious mental illness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center - Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Adaptation Training (CAT)

Remote Cognitive Adaptation Training (R-CAT)

Arm Description

A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.

A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.

Outcomes

Primary Outcome Measures

Acceptance of intervention
Proportion of subjects who dropped out of treatment
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.

Secondary Outcome Measures

Cost of treatment
Cost to include mail, supports, provider time in visit, preparation time and mileage
Pill count percent
Medication possession ratio from prescription refill data
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.
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.
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.

Full Information

First Posted
August 21, 2020
Last Updated
July 20, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04526067
Brief Title
In-person vs. Remote Wellness Support
Acronym
R-CAT
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))
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
Keywords
Serious mental illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel design
Masking
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.
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Adaptation Training (CAT)
Arm Type
Active Comparator
Arm Description
A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.
Arm Title
Remote Cognitive Adaptation Training (R-CAT)
Arm Type
Active Comparator
Arm Description
A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.
Intervention Type
Behavioral
Intervention Name(s)
CAT
Other Intervention Name(s)
Cognitive Adaptation Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
R-CAT
Other Intervention Name(s)
Remote Cognitive Adaptation Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptance of intervention
Description
Proportion of subjects who dropped out of treatment
Time Frame
Baseline to 6 months
Title
Medication Adherence
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Cost of treatment
Description
Cost to include mail, supports, provider time in visit, preparation time and mileage
Time Frame
Baseline to 6 months
Title
Pill count percent
Description
Medication possession ratio from prescription refill data
Time Frame
Baseline to 6 months
Title
Self-Report Habit Index (SRHI)
Description
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.
Time Frame
Baseline and at month 2, 4 and 6
Title
Symptomatology
Description
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.
Time Frame
Baseline and at month 2, 4 and 6
Title
Functional Outcome
Description
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.
Time Frame
Baseline and month 2, 4 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Velligan, PhD
Organizational Affiliation
University of Texas Health at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center - Department of Psychiatry
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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In-person vs. Remote Wellness Support

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