Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic

NCT ID: NCT01152697

Last Updated: 2014-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-08-31

Brief Summary

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.

Conditions

Patient Noncompliance

Keywords

nonadherence; noncompliance; homeless; schizophrenia; schizoaffective

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient Noncompliance

There was only one arm for this study.

Group Type: EXPERIMENTAL

haloperidol decanoate

Intervention Type: DRUG

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.

haloperidol

Intervention Type: DRUG

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.

Customized Adherence Enhancement

Intervention Type: BEHAVIORAL

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).

Interventions

haloperidol decanoate

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.

Intervention Type: DRUG

haloperidol

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.

Intervention Type: DRUG

Customized Adherence Enhancement

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).

2. Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.

3. Known to have medication treatment adherence (20% or more missed medications in past week or past month) problems as identified by the Treatment Routines Questionnaire patient or clinician versions (TRQ-P/TRQ-C).

4. Ability to be rated on psychiatric rating scales.

5. Willingness to take long-acting injectable medication.

6. Currently receiving treatment at a Community Mental Health Clinic (CMHC) or another mental health treatment provider who is able to provide continuity of care during and after study participation.

7. Able to provide written, informed consent to study participation.

8. Women of child-bearing potential must be utilizing reliable, medically-accepted methods of birth control.

Exclusion Criteria

1. Known resistance or intolerance to haloperidol or haloperidol decanoate.

2. Medical contraindication to haloperidol or haloperidol decanoate.

3. Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.

4. Prior or current treatment with clozapine.

5. Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial.

6. Current substance dependence.

7. High risk of harm to self or others.

8. Female who is currently pregnant or breastfeeding.

9. Individual who is already in permanent and supported housing that includes comprehensive mental health services (e.g. Housing First).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Martha Sajatovic

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha Sajatovic, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hosptials

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24434094 (View on PubMed)

Other Identifiers

Reuter-L1473

Identifier Type: -

Identifier Source: org_study_id