PAPSY - Memory in Psychiatry

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05843357
Collaborator
(none)
1,000
1
20.8
48

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    PAPSY: Snadné zjištění Poruch paměti pomocí Velmi krátkých testů ALBA a POBAV u psychiatrických diagnóz v celé ČR
    Actual Study Start Date :
    Mar 8, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    3. 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.

    4. 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.

    Secondary Outcome Measures

    1. 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)

    2. 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.

    3. 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).

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teaching Hospital Královské Vinohrady Praha Czechia 10000

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tadeáš Mareš, Consultation-liaison psychiatrist, Charles University, Czech Republic
    ClinicalTrials.gov Identifier:
    NCT05843357
    Other Study ID Numbers:
    • PAPSY
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tadeáš Mareš, Consultation-liaison psychiatrist, Charles University, Czech Republic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2023