Clinical trial NCT06061952: CAE for Poorly Adherent Individuals With Schizophrenia
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-09-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Average number of CAE sessions attended by those in the CAE group after 12 weeks
timeFrame: 12 weeks
measure: Percentage of subjects in the CAE group that agree or strongly agree that the intervention was useful at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) total score between CAE-S and eTAU groups at 12 weeks
timeFrame: 12 weeks
measure: Change in Tablets Routine Questionnaire (TRQ) at 12 weeks
timeFrame: 12 weeks
measure: Change in eCAP use at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References: