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CAE for Poorly Adherent Individuals With Schizophrenia (CAE-S)

Primary Purpose

Schizophrenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customized Adherence Enhancement for Schizophrenia (CAE-S)
Enhanced Treatment as Usual (eTAU)
Sponsored by
Martha Sajatovic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria: Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI) Prescribed an antipsychotic medication for treatment of schizophrenia Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month) Ability to be rated on psychiatric rating scales Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation Able to provide written, informed consent to study participation Has access to electronic device and internet to complete sessions conducted on videoconferencing platform Exclusion Criteria: Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence) Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist Immediate risk of harm to self or others Female who is currently pregnant or breastfeeding Does not have access to electronic device and internet to complete sessions conducted on videoconferencing platform

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Customized Adherence Enhancement for Schizophrenia (CAE-S)

Enhanced Treatment as Usual (eTAU)

Arm Description

CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use.

To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have.

Outcomes

Primary Outcome Measures

Average number of CAE sessions attended by those in the CAE group after 12 weeks
Percentage of subjects in the CAE group that agree or strongly agree that the intervention was useful at 12 weeks

Secondary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS) total score between CAE-S and eTAU groups at 12 weeks
The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia
Change in Tablets Routine Questionnaire (TRQ) at 12 weeks
The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.
Change in eCAP use at 12 weeks
Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.

Full Information

First Posted
September 25, 2023
Last Updated
October 18, 2023
Sponsor
Martha Sajatovic
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT06061952
Brief Title
CAE for Poorly Adherent Individuals With Schizophrenia
Acronym
CAE-S
Official Title
Prospective 12-week Randomized Controlled Trial (RCT) of Remotely- Delivered Customized Adherence Enhancement for Poorly Adherent Individuals With Schizophrenia (CAE-S) vs Enhanced Treatment as Usual (eTAU)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martha Sajatovic
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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

5. Study Description

Brief Summary
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
Detailed Description
Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine the posited mechanistic underpinnings of the CAE-S intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the Tablets Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary measures will include the Clinical Global Impression (CGI), functional status, quality of life and attitudes towards medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Customized Adherence Enhancement for Schizophrenia (CAE-S)
Arm Type
Experimental
Arm Description
CAE is an adjunctive (to standard medication treatment) behavioral intervention delivered virtually (real-time one on one video-conferencing) in 6 individual sessions. All participants will receive content from the 4 currently existing CAE modules delivered over a 6-session series spaced out over approximately 6-10 weeks. The material from the 4 modules will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules themselves are delivered in sections (thematic units within the module) and do not correspond to a specific session. The 4 CAE modules are Psychoeducation, Communication with Providers, Medication Routines, and Substance Use.
Arm Title
Enhanced Treatment as Usual (eTAU)
Arm Type
Other
Arm Description
To optimize control intervention rigor, the eTAU participants will view a pre-taped series of 6 videos (based on NAMI or DBSA general wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the CAE mental health clinician. The therapist will view the video with the participant and field questions the patient may have.
Intervention Type
Behavioral
Intervention Name(s)
Customized Adherence Enhancement for Schizophrenia (CAE-S)
Intervention Description
6-session series spaced out over approximately 6-10 weeks
Intervention Type
Other
Intervention Name(s)
Enhanced Treatment as Usual (eTAU)
Intervention Description
eTAU participants will view a pre-taped series of 6 videos
Primary Outcome Measure Information:
Title
Average number of CAE sessions attended by those in the CAE group after 12 weeks
Time Frame
12 weeks
Title
Percentage of subjects in the CAE group that agree or strongly agree that the intervention was useful at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) total score between CAE-S and eTAU groups at 12 weeks
Description
The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia
Time Frame
12 weeks
Title
Change in Tablets Routine Questionnaire (TRQ) at 12 weeks
Description
The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.
Time Frame
12 weeks
Title
Change in eCAP use at 12 weeks
Description
Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI) Prescribed an antipsychotic medication for treatment of schizophrenia Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month) Ability to be rated on psychiatric rating scales Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation Able to provide written, informed consent to study participation Has access to electronic device and internet to complete sessions conducted on videoconferencing platform Exclusion Criteria: Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence) Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist Immediate risk of harm to self or others Female who is currently pregnant or breastfeeding Does not have access to electronic device and internet to complete sessions conducted on videoconferencing platform
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gracie Howard-Griggs
Phone
888-819-0004
Email
Gracie.HowardGriggs@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gracie Howard-Griggs
Phone
888-819-0004
Email
Gracie.HowardGriggs@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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CAE for Poorly Adherent Individuals With Schizophrenia

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