- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04526067
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
Status
Completed
Intervention / Treatment
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:
- 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
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:
|
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:
|
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.
Collaborators
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
Keywords
Additional Relevant MeSH Terms
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
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.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on CAT
-
MedImmune LLCAstraZeneca; MedImmune LtdCompleted
-
National Institute of Allergy and Infectious Diseases...Circassia LimitedCompletedCat Allergy | Cat HypersensitivityCanada
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)TerminatedAsthma AtopicUnited States
-
Aier School of Ophthalmology, Central South UniversityUnknown
-
Massachusetts General HospitalCompletedHand SurgeryUnited States
-
Swiss Tropical & Public Health InstituteCompletedSatisfaction | Station AtmosphereSwitzerland
-
Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.Completed
-
Medical University of South CarolinaCompletedAnxiety | Autism Spectrum Disorder | AutismUnited States
-
Boston Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...WithdrawnDiabetes Mellitus, Type 2United States
-
Circassia LimitedAdiga Life Sciences, Inc.Completed