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

NCT ID: NCT02085447

Last Updated: 2019-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychotic Disorders Schizophrenia Schizoaffective Disorder Medication Adherence Medication Non-Adherence

Keywords

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Homelessness Antipsychotic Drugs Antipsychotics Injectables Long Acting Injectable Antipsychotic Psychotic Disorders Schizophrenia Schizoaffective Disorder Medication Adherence Medication Non-Adherence Community Mental Health Centers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CAE-L

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.

Group Type EXPERIMENTAL

CAE-L

Intervention Type BEHAVIORAL

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.

Interventions

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CAE-L

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CAE Customized Adherence Enhancement LAI Long Acting Injectable Antipsychotic Haldol Decanoate haloperidol decanoate Invega Sustenna paliperidone palmitate

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Martha Sajatovic

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha Sajatovic, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R092670SCH4031

Identifier Type: -

Identifier Source: org_study_id