PAPSY - Memory in Psychiatry (PAPSY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ales Bartos, M.D., Ph.D.; Phone Number: 00420267162297; Email: ales.bartos@fnkv.cz
• Study Contact Backup: Name: Tadeáš Mareš, M.D.; Phone Number: 00420224965342; Email: tadeas.mares@vfn.cz

Study Locations

• Czechia
  • Praha, Czechia, 10000
    • Recruiting
    • Teaching Hospital Královské Vinohrady
    • Contact: Ales Bartos, M.D., Ph.D.; Phone Number: 00420267162297; Email: ales.bartos@fnkv.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population is intended to be comprised of persons (45yrs+) living in the geographical area of the Czech Republic undergoing a treatment at an outpatient psychiatric office for a diagnosis defined in ICD-10 (excluding mental retardation). The probability sample will be created by a random selection of persons undergoing their regular outpatient psychiatric checkups.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observed group; 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?

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.

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Aleš Bartoš, M.D., Ph.D., Charles University, Czech Republic; Principal Investigator: Tadeáš Mareš, M.D., Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Outpatient Psychiatric Service; Population Distribution
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PAPSY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD is to be shared upon request by a verified researcher. The study director´s discretion is reserved.
• IPD Sharing Time Frame: Upon the final publication of the outcomes, indefinitely.
• IPD Sharing Access Criteria: Being a verified researcher.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No