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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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The objective of this protocol is to develop items for a patient-reported outcome (PRO) measure to assess the patient's perspective and subjective experience of cognitive impairment associated with schizophrenia (CIAS).
Cognitive impairment associated with schizophrenia (CIAS) has been shown to be the strongest predictor of functional impairment among people with schizophrenia because it is associated with poor response to psychosocial interventions, employment status, and social functioning. Because the subjective experience of CIAS is likely to be associated with patient burden, distress, and motivation for treatment, it is important that this experience be assessed in a reliable and valid manner and from the perspective of the patient's self report. No existing instrument to assess CIAS has been developed with patient input directly about their qualitative experience of impaired cognition during the item generation stage, in accordance with FDA guidance for patient-reported outcome (PRO) measures.
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Impairment Associated with Schizophrenia | Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure. | One time qualitative interivew within two weeks of screening |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Conceptual Model using Qualitative Interviews | Semi structured qualitative interviews will be conducted with adult subjects with schizophrenia. The results of the interviews will be analyzed using standard methods of inductive, iterative analysis. The results will serve as the basis for generating draft items for the PRO measure. | One time qualitative interivew |
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Inclusion Criteria:
Patients with established diagnoses of schizophrenia (confirmed by the Structured Clinical Interview for DSM-IV [full version or Clinical Trial version] either performed as part of the study screening process or as documented in the medical record within 2 years prior to the study) with the following clinical features:
Male or female patients age 18 to 55 years
Exhibits reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures.
Able to provide informed consent
Exclusion Criteria:
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Adults with formal dx of schizo aged 18-55, stabe (non-acute phase), on stable medications
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| Name | Affiliation | Role |
|---|---|---|
| Raymond C Rosen, PhD | New England Research Institutes, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheppard Pratt Health System | Baltimore | Maryland | 21285 | United States | ||
| Massachusetts General Hospital |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019965 | Neurocognitive Disorders |
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No biospecimens collected
| Assess content validity and comprehension of developed PRO measure | Following generation of draft PRO items, an independent series of qualitative interviews will take place in order to evaluate the draft items and ensure they accurately reflect the patient experience of cognitive impairment associated with schizophrenia. | One time qualitative interivew |
| Development and testing of a new patient reported outcome (PRO) measure | Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure. | Patients will be interviewed within 2 weeks of consent |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Rutgers University Robert Wood Johnson Medical School | Piscataway | New Jersey | 08854 | United States |
| Richmond Behavior Associates | Staten Island | New York | 10312 | United States |