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CAE-L
A Prospective Trial of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L) in Individuals With Schizophrenia or Schizoaffective Disorder at Risk for Treatment Non-adherence and for Homelessness
Sponsor study identifier
interventional
30
1 country
1
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
August 2012
Actual (reported)Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a 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. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors. This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 24, 2010
Actual (reported)June 29, 2010
Actual (reported)August 2012
Actual (reported)August 2012
Actual (reported)June 4, 2014
Actual (reported)Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks
Subjects will be asked how many days they have been homeless
Baseline-25 weeks
Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks
A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.
Baseline-25 weeks
Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks
Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
Baseline-25 weeks
Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks
Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.
Baseline-25 weeks
Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks
Frequency of Health Resource Use Throughout Months 10, 11, and 12
Month 1-3, Month 10-12
Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks
Baseline-25 weeks
Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks
Baseline-25 weeks
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks
Baseline-25 weeks
Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks
25 weeks
There was only one arm for this study.
Drug is in in injectable form and will be administered approximately every four weeks through Week 25 of the study. A participant may continue on the drug after Week 25 at the discretion of his or her treating psychiatrist. Dosage is per package insert or at the discretion of the psychiatrist.
Drug will be administered in oral form to participants not already taking oral haloperidol and then transitioned to the injectable version. Dosage and frequency is at the discretion of the psychiatrist.
University Hosptials
Cleveland, Ohio, 44106, United States
Sajatovic M, Levin J, Ramirez LF, Hahn DY, Tatsuoka C, Bialko CS, Cassidy KA, Fuentes-Casiano E, Williams TD. Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2013 Dec;74(12):1249-55. doi: 10.4088/JCP.12m08331.
Martha Sajatovic, MD
University Hospitals Cleveland Medical Center
30 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2010
First Posted
June 29, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.
Baseline-25 weeks
CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2012
Actual (reported)Study Completion
August 2012
Actual (reported)Last Updated
December 30, 2014
Results First Posted
June 4, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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