PAPSY - Memory in Psychiatry

Study Overview
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Brief Summary
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Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. 1000 patients in 90 psychiatric offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (sFAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms. If applicable, caretakers will also be asked about the extent of the participant's autonomy and behavioral impairment (using oFAQ-CZ and MBI-C-CZ scales). The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in psychiatric care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.

Official Title
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PAPSY: Snadné zjištění Poruch paměti pomocí Velmi krátkých testů ALBA a POBAV u psychiatrických diagnóz v celé ČR

Conditions
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Cognitive Impairment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dispensarization of at least six months in an outpatient psychiatric office with an ICD-10 diagnosis Age>=45 Permanent residency in the geographical area of the Czech Republic Exclusion Criteria: Diagnosis of mental retardation (F70-F79) according to ICD-10 Refusal to sign the informed consent and consent with GDPR Uncorrected visual impairment Uncorrected auditory impairment Inability to participate in the project

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observed group<br>No intervention will be administered on behalf of the project. The participants will be tested using ALBA and PICNIR (non-invasive) cognitive tests, and further sFAQ-CZ and GDS-CZ questionnaires will be administered. Questionnaires FAQ-CZ and MBI-C-CZ will be distributed to participants´ caretakers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline ALBA | Amnesia Light and Brief Assessment (ALBA) test is an innovative method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-12 (a lower value denotes a more severe cognitive impairment). | Established on Day 0 as a single assessment. | 
| Baseline PICNIR | Picture Naming and Immediate Recall test (PICNIR) is an innovative test method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-20 (a lower value denotes a more severe cognitive impairment). | Established on Day 0 as a single assessment. | 
| Statistical analysis of ALBA results, | Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data. | The final statistical analysis will be performed through study completion, an average of 6 months. | 
| Statistical analysis of PICNIR results. | Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data. | The final statistical analysis will be performed through study completion, an average of 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline MBI-C-CZ | Mild Behavioral Impairment - Checklist - Czech version (MBI-C-CZ) is a standardized questionnaire to assess behavioral impairment in 34 items. Each item is scaled between 0-3 (a higher value denotes a higher severity) to reach the overall score between 0-102 (a higher value denotes a higher overall severity of behavioral impairments) | Established as a baseline on Day 0. | 
| Baseline sFAQ-CZ | Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for participants´ self-evaluation. | Established as a baseline on Day 0. | 
| Baseline GDS-CZ | The Geriatric Depression Scale - Czech version (GDS-CZ) is a standardized questionnaire administered to assess depressive symptoms, particularly in the elderly population. Fifteen items are scaled between 0-1 to reach the overall score between 0-15 (a higher value denotes a higher level of depressive symptoms). | Established as a baseline on Day 0. | 
| Baseline oFAQ-CZ | Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for caretakers´ evaluation of participants´ functioning. | Established as a baseline on Day 0. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Impairment, Outpatient Psychiatric Service, Population Distribution