PAPSY - Memory in Psychiatry

Cognitive Impairment Clinical Trial

— PAPSY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843357
• Other study ID #: PAPSY
• Status: Recruiting
• Start date: March 8, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: Aleš Bartoš, M.D., Ph.D.
• Phone: 00420267162297
• Email: ales.bartos[@]fnkv.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Locations

Country	Name	City	State
Czechia	Teaching Hospital Královské Vinohrady	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.