Overview

This trial is active, not recruiting.

Conditions psychotic disorders, schizophrenia, schizoaffective disorder, medication adherence, medication non-adherence
Treatment cae-l
Sponsor University Hospitals Cleveland Medical Center
Start date May 2014
End date November 2016
Trial size 30 participants
Trial identifier NCT02085447, R092670SCH4031

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
cae-l CAE
Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.

Primary Outcomes

Measure
Change in Tablets Routine Questionnaire (TRQ) from Screen to Week 25 visit
time frame: Screen, Week 25
LAI Injection Adherence
time frame: Week 25

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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)

Additional Information

Official title A Concierge Model of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAL-C) in Individuals With Schizophrenia at Risk for Treatment Non-adherence and for Homelessness
Principal investigator Martha Sajatovic, MD
Description Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia, but rates of full or partial non-adherence exceed 60%. There is direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. Long-acting injectable antipsychotic (LAI) medication can improve adherence but needs to be combined with a quality behavioral program to modify long-term attitudes and behaviors. A recently completed study funded by the Reuter Foundation and conducted by these investigators found that a novel customized psychosocial adherence enhancement intervention paired with LAI (CAE-L) reduced rates of homelessness, improved psychiatric symptoms and increased overall functioning in this very vulnerable group of individuals. CAE has been manualized and appears very acceptable to homeless people with serious mental illness. However, in spite of the very promising results, the CAE-L intervention has some important limitations that are barriers to its wide-spread future use in public health settings. These limitations are: 1. CAE-L used a PhD-level psychologist to deliver the behavioral part of the program. Many public-sector clinical settings have a very limited number of such highly trained individuals. As an alternative, social workers could be an efficient way to deliver CAE. 2. CAE-L used only haloperidol decanoate as the injectable medication. Unfortunately, akathisia-- a very distressing side effect, occurred in 40% of people. Use of a newer, better tolerated medication option could improve the investigators approach. 3. Logistic barriers preventing people who were stabilized and doing well on CAE-L to continue their improved functioning once they transitioned back to regular care settings. It is clear that there needs to be a mechanism to facilitate the successful "hand-off" of individuals who have benefitted from CAE-L into maintenance therapy. A successful transition could have substantial financial and humanitarian cost-savings. To address these obstacles and in preparation for a large-scale randomized controlled trial of this novel, blended intervention the investigators propose to conduct a prospective study using a concierge model of customized adherence enhancement combined with a long-acting injectable antipsychotic (CAL-Concierge) in individuals with schizophrenia 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center.