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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)
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Start Date
January 16, 2024
Primary Completion Date
August 9, 2025
Completion Date
August 9, 2025
Last Updated
November 18, 2025
36
ACTUAL participants
Customized Adherence Enhancement for Schizophrenia (CAE-S)
BEHAVIORAL
Enhanced Treatment as Usual (eTAU)
OTHER
Lead Sponsor
University Hospitals Cleveland Medical Center
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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