The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.
This is a randomized, open-label, parallel group study of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder and their caregivers. Study will consist of a paired patient and caregiver. Patients will receive routine treatment, which may include oral antipsychotics or paliperidone palmitate, as directed by their treating physician. Caregivers for patients whose routine treatment is paliperidone palmitate will be randomized to receive either a study-provided caregiver psycho-education and skills training or usual caregiver support. Caregivers for patients whose routine treatment is oral antipsychotics will be randomized to the same Study Groups: Study Group 1: Study-provided caregiver psycho-education and skills training. Study Group 2: Usual caregiver support (caregiver support that is customarily provided by the study site, if any). Patients-caregiver pairs will be followed for up to 12 months following baseline assessment. Cumulative number of treatment failures over 12 months will be assessed primarily.
Study Type
OBSERVATIONAL
Enrollment
296
Caregivers will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period.
Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
Unnamed facility
Bullhead City, Arizona, United States
Number of Treatment Failures Over 12 Months
Treatment failure is defined as any of the following: 1. Psychiatric hospitalization 2. Psychiatric emergency room (ER) visit 3. Crisis center visit 4. Mobile crisis unit intervention 5. Arrest/Incarceration 6. Suicide or suicide attempt.
Time frame: 12 months
Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12
The IEQ is designed to measure levels of caregiver consequences among family members and friends of patients with schizophrenia. The 31 items included in this scale are answered on a 5 point Likert response scale and address consequences among 4 dimensions (tension, supervision, worrying, and urging).
Time frame: Month 12
Number of Treatment Failures in Patients Taking Oral Antipsychotics
Treatment failure is defined as any of the following: 1. Psychiatric hospitalization 2. Psychiatric emergency room (ER) visit 3. Crisis center visit 4. Mobile crisis unit intervention 5. Arrest/Incarceration 6. Suicide or suicide attempt.
Time frame: 12 months
Number of Treatment Failures in Patients Taking Paliperidone Palmitate
Treatment failure is defined as any of the following: 1. Psychiatric hospitalization 2. Psychiatric emergency room (ER) visit 3. Crisis center visit 4. Mobile crisis unit intervention 5. Arrest/Incarceration 6. Suicide or suicide attempt.
Time frame: 12 months
Patient Recovery Based on Total Illness Management and Recovery (IMR) Score
The IMR program was developed in order to help patients with schizophrenia or major mood disorders learn how to manage their illnesses more effectively in the context of pursuing their personal goals.
Time frame: Month 6 and Month 12
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Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Unnamed facility
Oceanside, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Farmington, Connecticut, United States
Unnamed facility
Lauderdale Lakes, Florida, United States
Unnamed facility
Leesburg, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orange City, Florida, United States
Unnamed facility
Tallahassee, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
...and 24 more locations
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12
The CGI-S rating scale is used to rate the severity of a patient's overall clinical condition on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) to 7 (amongst the most severely ill patients).
Time frame: Month 12
Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12
The 12-item Short Form Health Survey (SF-12) is a self-administered, generic, 12-item questionnaire designed to cover the same 8 domains of functional health status and well-being included in the longer 36-item Short Form Health Survey (SF 36): physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Time frame: Month 12