Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic

NCT01152697 | Completed Results DMC

• 1 other identifier: Reuter-L1473
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

  Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.

  Baseline-25 weeks

Secondary Outcomes (15)

• 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

Study Arms (1)

Patient Noncompliance

EXPERIMENTAL

There was only one arm for this study.

Drug: haloperidol decanoate; Drug: haloperidol; Behavioral: Customized Adherence Enhancement

Interventions

haloperidol decanoate 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.

Patient Noncompliance

haloperidol 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.

Patient Noncompliance

Customized Adherence Enhancement 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).

Patient Noncompliance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).
• Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.
• 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).
• Ability to be rated on psychiatric rating scales.
• Willingness to take long-acting injectable medication.
• 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.
• Able to provide written, informed consent to study participation.
• Women of child-bearing potential must be utilizing reliable, medically-accepted methods of birth control.

You may not qualify if:

• Known resistance or intolerance to haloperidol or haloperidol decanoate.
• Medical contraindication to haloperidol or haloperidol decanoate.
• Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
• Prior or current treatment with clozapine.
• 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.
• Current substance dependence.
• High 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 (e.g. Housing First).

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator

Study Sites (1)

University Hosptials

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 24434094 DERIVED

MeSH Terms

Conditions

Patient Compliance; Schizophrenia

Interventions

haloperidol decanoate; Haloperidol

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Martha Sajatovic, Professor of Psychiatry
• Organization: University Hospitals of Cleveland

martha.sajatovic@uhhospitals.org

2168442808

Study Officials

• Martha Sajatovic, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 30, 2014
• Results First Posted: June 4, 2014

Record last verified: 2014-12

Locations

US (1)