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

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ClinicalTrials.gov Identifier: NCT04526067
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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
Depressive Disorder, Major Bipolar Disorder Schizo Affective Disorder Schizophrenia Behavioral: CAT Behavioral: R-CAT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : November 24, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Remote Cognitive Adaptation Training




Primary Outcome Measures :
  1. Acceptance of intervention [ Time Frame: Baseline to 6 months ]
    Proportion of subjects who dropped out of treatment

  2. 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.


Secondary Outcome Measures :
  1. Cost of treatment [ Time Frame: Baseline to 6 months ]
    Cost to include mail, supports, provider time in visit, preparation time and mileage

  2. Pill count percent [ Time Frame: Baseline to 6 months ]
    Medication possession ratio from prescription refill data

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526067


Contacts
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Contact: Dawn Velligan, PhD 210-567-5509 velligand@uthscsa.edu
Contact: Feiyu Li, PhD 210-567-5594 LiF4@uthscsa.edu

Locations
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United States, Texas
University of Texas Health Science Center - Department of Psychiatry Recruiting
San Antonio, Texas, United States, 78229
Contact: Dawn I Velligan, PhD    210-567-5508    velligan@uthscsa.edu   
Contact: Feiyu Li, PhD    210567-5594    Lif4@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Dawn Velligan, PhD University of Texas Health at San Antonio
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04526067    
Other Study ID Numbers: HSC20200525H
1R56MH123797 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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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:
Serious mental illness
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Bipolar Disorder
Depressive Disorder, Major
Mood Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders