Clinical trial NCT05843357: PAPSY - Memory in Psychiatry
Official title: PAPSY: Snadné zjištění Poruch paměti pomocí Velmi krátkých testů ALBA a POBAV u psychiatrických diagnóz v celé ČR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Impairment
Keywords: Cognitive Impairment
Outpatient Psychiatric Service
Population Distribution
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline ALBA
timeFrame: Established on Day 0 as a single assessment.
measure: Baseline PICNIR
timeFrame: Established on Day 0 as a single assessment.
measure: Statistical analysis of ALBA results,
timeFrame: The final statistical analysis will be performed through study completion, an average of 6 months.
measure: Statistical analysis of PICNIR results.
timeFrame: The final statistical analysis will be performed through study completion, an average of 6 months.
Secondary outcomes:
measure: Baseline MBI-C-CZ
timeFrame: Established as a baseline on Day 0.
measure: Baseline sFAQ-CZ
timeFrame: Established as a baseline on Day 0.
measure: Baseline GDS-CZ
timeFrame: Established as a baseline on Day 0.
measure: Baseline oFAQ-CZ
timeFrame: Established as a baseline on Day 0.
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Teaching Hospital Královské Vinohrady
Study officials:
affiliation: Charles University, Czech Republic
name: Aleš Bartoš, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University, Czech Republic
name: Tadeáš Mareš, M.D.
role: PRINCIPAL_INVESTIGATOR
References: