PAPSY - Memory in Psychiatry

Recruiting

• Conditions: Cognitive Impairment

• Registration Number: NCT05843357
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-08
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Primary Completion: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline ALBA	Established on Day 0 as a single assessment.	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).
Baseline PICNIR	Established on Day 0 as a single assessment.	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).
Statistical analysis of PICNIR results.	The final statistical analysis will be performed through study completion, an average of 6 months.	Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.
Statistical analysis of ALBA results,	The final statistical analysis will be performed through study completion, an average of 6 months.	Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.

Secondary Outcome Measures

Name	Time	Method
Baseline oFAQ-CZ	Established as a baseline on Day 0.	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.
Baseline MBI-C-CZ	Established as a baseline on Day 0.	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)
Baseline sFAQ-CZ	Established as a baseline on Day 0.	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.
Baseline GDS-CZ	Established as a baseline on Day 0.	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).

Trial Locations

Locations (1)

Teaching Hospital Královské Vinohrady; 🇨🇿 Praha, Czechia