A Concierge Model of CAE Plus LAI in Individuals With Schizophrenia at Risk for Treatment Non-adherence and Homelessness

Completed · Not applicable

Conditions studied: Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Medication Adherence, Medication Non-Adherence

In brief

This is a prospective study using a concierge model of customized adherence enhancement and long-acting injectable antipsychotic (CAL-Concierge) in 30 individuals with schizophrenia or schizoaffective disorder at risk for treatment non-adherence and for homelessness. Like the CAE-L approach, CAL-Concierge is expected to improve health outcomes among the most vulnerable of populations with schizophrenia but even more importantly, will demonstrate that it can be used to improve the efficiency and quality of care in typical practice settings.

Key facts

Study ID

NCT02085447

Run by

University Hospitals Cleveland Medical Center

People needed

30

Starts

2014-05-01

Expected to finish

2016-12-01

Last updated by the study team

2019-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals age 18 and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI). The investigators will use a DSM-5 concordant version of the MINI if it is available at the time that the first study participant is enrolled.
• Individuals who are currently or have been recently homeless (within the past 12 months) as per revised federal definition of homelessness (Homeless Emergency Assistance and Rapid Transition to Housing. In: Development DoHaU, ed2011.)
• Known to have medication treatment adherence problems as identified by the Treatment Routines Questionnaire (TRQ, 20% or more missed medications in past week or past month)
• Ability to be rated on psychiatric rating scales.
• Willingness to take long-acting injectable medication
• Currently in treatment at a Community Mental Health Clinic (CMHC) or other treatment setting able to provide mental health care during and after study participation
• Able to provide written, informed consent to study participation.

You may not qualify if…

• Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
• Prior or current treatment with clozapine
• 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
• Individual who is already in permanent and supported housing that includes comprehensive mental health services (i.e. Housing First)

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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