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

NCT02085447 | Completed Results DMC

• 1 other identifier: R092670SCH4031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Medication Adherence; Medication Non-Adherence

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit

  The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.

  Screen, Week 25

• Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25

  The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.

  Screen, Week 25

• Long-acting Injection (LAI) Adherence

  Long-acting injection (LAI) adherence will be determined as a proportion of LAI (paliperidone palmitate or haloperidol decanoate) injections received at the appropriate time (within 7 days of scheduled time).

  Week 25

Secondary Outcomes (19)

• Change in DAI (Drug Attitudes Index) From Screen to Week 25

  Screen, Week 25

• Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25

  Screen, Week 25

• Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25

  Screen, Week 25

• Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25

  Screen, Week 25

• Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25

  Screen, Week 25

Study Arms (1)

CAE-L

EXPERIMENTAL

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.

Behavioral: CAE-L

Interventions

CAE-L 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.

Also known as: CAE, Customized Adherence Enhancement, LAI, Long Acting Injectable Antipsychotic, Haldol Decanoate, haloperidol decanoate, Invega Sustenna, paliperidone palmitate

CAE-L

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 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Medication Adherence

Interventions

Haloperidol; haloperidol decanoate; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Martha Sajatovic
• Organization: University Hospitals Cleveland Medical Center

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: March 3, 2014
• First Posted: March 12, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 9, 2019
• Results First Posted: December 9, 2019

Record last verified: 2019-12

Locations

US (1)