CAE for Poorly Adherent Individuals With Schizophrenia

Schizophrenia Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061952
• Other study ID #: STUDY20230135
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Gracie Howard-Griggs
• Phone: 888-819-0004
• Email: Gracie.HowardGriggs[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Customized Adherence Enhancement for Schizophrenia (CAE-S)
6-session series spaced out over approximately 6-10 weeks

Other:
• Enhanced Treatment as Usual (eTAU)
eTAU participants will view a pre-taped series of 6 videos

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Martha Sajatovic	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average number of CAE sessions attended by those in the CAE group after 12 weeks		12 weeks
Primary	Percentage of subjects in the CAE group that agree or strongly agree that the intervention was useful at 12 weeks		12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks