Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L)

This study has been completed.
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01152697
First received: June 24, 2010
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Patient Noncompliance
Drug: haloperidol decanoate
Drug: haloperidol
Behavioral: Customized Adherence Enhancement

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]
    Subjects will be asked how many days they have been homeless

  • Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]
    Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.

  • Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]
    Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.

  • Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]
    Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.


Secondary Outcome Measures:
  • Frequency of Health Resource Use Throughout Months 10, 11, and 12 [ Time Frame: Month 1-3, Month 10-12 ] [ Designated as safety issue: No ]
    The frequency of health resource use will be measured through interview of the participant.

  • Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]

    The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87.

    Scale Range: 18-126 Lower scores represent improved outcomes.


  • Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]

    Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.

    Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)


  • Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]
    Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.

  • Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

    Satisfaction will be measured by a seven item inventory taken by the participant.

    Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35.


  • Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks [ Time Frame: Baseline-25 weeks ] [ Designated as safety issue: No ]

    The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness.

    There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes.

    Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes.


  • Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    The frequency of health resource use will be measured through interview of the participant.

  • Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.

    Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)


  • Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months [ Time Frame: Baseline-12 months ] [ Designated as safety issue: No ]
    Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.

  • Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Satisfaction will be measured by a seven item inventory taken by the participant.

    Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35.


  • Days Homeless Out of the Previous 6 Months as Measured at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjects will be asked how many days they have been homeless

  • Treatment Adherence Score as Measured at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.

  • Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes.

  • Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.


Enrollment: 30
Study Start Date: June 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient Noncompliance
There was only one arm for this study.
Drug: 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.
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.
Behavioral: 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152697

Locations
United States, Ohio
University Hosptials
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Case Western Reserve University
Investigators
Principal Investigator: Martha Sajatovic, MD University Hospitals of Cleveland
  More Information

No publications provided by University Hospitals of Cleveland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martha Sajatovic, Professor of Psychiatry, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01152697     History of Changes
Other Study ID Numbers: Reuter-L1473
Study First Received: June 24, 2010
Results First Received: December 28, 2013
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
nonadherence
noncompliance
homeless
schizophrenia
schizoaffective

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Haloperidol decanoate
Antipsychotic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on July 22, 2014