N/A
Completed N=30
A Concierge Model of CAE Plus LAI in Individuals With Schizophrenia at Risk for Treatment Non-adherence and Homelessness
Source: ClinicalTrials.gov NCT02085447 ↗Enrolled (actual)
30
Serious AEs
23.3%
Results posted
Dec 2019
Primary outcomePrimary: Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit — 56.2 percentage of adherence — p=.012
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit |
56.2 | .012 sig |
| PRIMARY Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25 |
15.2 | .028 sig |
| PRIMARY Long-acting Injection (LAI) Adherence |
90.5 | .162 |
| SECONDARY Change in DAI (Drug Attitudes Index) From Screen to Week 25 |
8.5 | .021 sig |
| SECONDARY Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25 |
4.0 | .005 sig |
| SECONDARY Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25 |
21.2 | <.001 sig |
| SECONDARY Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25 |
12.1 | .197 |
| SECONDARY Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25 |
.8 | <.001 sig |
| SECONDARY Change in PANSS (Positive and Negative Syndrome Scale; General Psychopathology) From Screen to Week 25 |
24.7 | <.001 sig |
| SECONDARY Change in CGI (Clinical Global Impression) From Screen to Week 25 |
2.9 | <.001 sig |
| SECONDARY Change in ASSIST GRS (Alcohol, Smoking and Substance Involvement Screening Test ) From Screen to Week 25 |
2.0 | .053 |
| SECONDARY Change in SOFAS (Social and Occupational Functioning Assessment Scale) From Screen to Week 25 |
63.1 | <.001 sig |
| SECONDARY Change in AIMS (Abnormal Involuntary Movement Scale) From Baseline to Week 25 |
1.5 | .821 |
| SECONDARY Change in SAS (Simpson Angus Scale) From Screen to Week 25 |
0.0 | .330 |
| SECONDARY Change in BARS (Barnes Akathisia Rating Scale) From Screen to Week 25 |
.3 | .425 |
| SECONDARY Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Parkinsonism) From Screen to Week 25 |
0.0 | .577 |
| SECONDARY Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dystonia) From Screen to Week 25 |
0.0 | .330 |
| SECONDARY Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dyskinesia) From Screen to Week 25 |
1.4 | .706 |
| SECONDARY Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Akathisia) |
.2 | .481 |
| SECONDARY Change in Hospitalizations (Psychiatric) in the Past 6 Months From Screen and Week 25 |
.2 | .020 sig |
| SECONDARY Change in Hospitalizations (Medical) in the Past 6 Months From Screen and Week 25 |
.2 | .103 |
| SECONDARY Percentage Change of Days of Sub-optimal Housing in the Past Six Months; Change From Screen to Week 25 |
29.0 | .063 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02085447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.