Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective

April 19, 2024 updated by: Bartosz M. Radtke

Cognitive Functioning Profiles in Adults With Neurologically Recognized Aphasic Syndromes and General Population From a Biopsychosocial Perspective

The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population.

The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants.

The main questions it aims to answer are:

  1. What is the profile of memory and learning among polish adults?
  2. Do gender and age moderates patterns of memory and learning functioning among polish adults?
  3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes?
  4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?

Researchers will compare the following groups of adults:

  1. general population/control group
  2. with neurologically recognized aphasic syndromes
  3. seniors (over 60 y.o.)

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Pomerania
      • Gdansk, Pomerania, Poland, 80-239
        • Recruiting
        • Laboratory of Psychological and Educational Tests
        • Contact:
        • Sub-Investigator:
          • Rafał Nowicki, M.A.
        • Sub-Investigator:
          • Artur Sawicki, M.A.
        • Principal Investigator:
          • Urszula Sajewicz-Radtke, Ph.D.
        • Principal Investigator:
          • Bartosz M Radtke, Ph.D.
        • Principal Investigator:
          • Ariadna Łada-Maśko, Ph.D.
        • Sub-Investigator:
          • Beata Daniluk, Ph.D.
        • Sub-Investigator:
          • Piotr Markiewicz, Ph.D.
        • Sub-Investigator:
          • Paweł Jurek, Ph.D.
        • Sub-Investigator:
          • Michał Olech, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Polish adults.

Description

Inclusion criteria for general population/control group:

  • age from 18 to 60 y.o.

Inclusion criteria for neurologically recognized aphasic syndromes

  • age above 18 y.o.
  • neurologically recognized aphasic syndromes

Inclusion criteria for seniors:

  • age above 60 y.o.

Exclusion criteria for general population/control group:

  • age less then 18 y.o.
  • neurologically recognized aphasic syndromes

Exclusion criteria for neurologically recognized aphasic syndromes

  • age less then 18 y.o.
  • no neurologically recognized aphasic syndromes

Exclusion criteria for seniors

  • age less then 60 y.o.
  • diseases of the nervous system, such as: stroke, craniocerebral trauma, neuroinfections, neurodegenerative diseases
  • mental disorders such as depression, psychotic disorders, anxiety disorders, addictions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General population/control group
Polish adults (age 18 to 60 y.o).
Psychological assessment of memory, learning and language
Neurologically recognized aphasic syndromes
Polish adults (age 18 to 60 y.o) with neurologically recognized aphasic syndromes.
Psychological assessment of memory, learning and language
Seniors (over 60 y.o)
Polish adults (over 60 y.o.)
Psychological assessment of memory, learning and language

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic data
Time Frame: July 3, 2023 until March 31, 2025
Author's survey of socio-demographic data, including: gender, month and year of birth, region of residence
July 3, 2023 until March 31, 2025
Memory and learning
Time Frame: July 3, 2023 until March 31, 2025
Test of Memory and Learning (second edition). A standardized test measuring memory functioning and learning abilities. The test includes four basic factors (Verbal Memory, Nonverbal Memory, Complex Memory, and Delayed Recall) and five supplementary factors (Attention/Concentration, Sequential Memory, Free Recall, Associative Recall and Learning). The raw scores obtained in each tested subscale are converted into scores scaled based on age norms, ranging from 1 to 20, where a higher score means better functioning of the examined area, and a lower result means poorer functioning.
July 3, 2023 until March 31, 2025
Language
Time Frame: July 3, 2023 until March 31, 2025
Boston Diagnostic Aphasia Examination-Third Edition. A spectrum of tools that helps to identify and distinguish among disorders of language function and neurologically recognized aphasic syndromes. The test have five functional subsections: 1) Conversational and Expository Speech, 2) Auditory Comprehension, 3) Oral Expression, 4) Reading and 5) Writing. The raw scores obtained in each tested subscale are converted into a percentile scale, ranging from 1 to 100, where a higher score means better functioning of the examined area, and a lower result means poorer functioning.
July 3, 2023 until March 31, 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related data
Time Frame: July 3, 2023 until March 31, 2025
Author's survey of health related data, including: hearing, eyesight, hypertension, atherosclerosis, previous heart attack, diabetes, endocrine diseases, respiratory system diseases, musculoskeletal system diseases, nervous system diseases, kidney diseases, sleep disorders, hospitalizations, procedures under general anesthesia, cancer, medications.
July 3, 2023 until March 31, 2025
Education data
Time Frame: July 3, 2023 until March 31, 2025
Author's survey of education, including: years of education, level of education, occupation, level of education of the participant's parents.
July 3, 2023 until March 31, 2025
General mental state
Time Frame: July 3, 2023 until March 31, 2025
Mini-Mental State Examination. A clinical scale used to examine disorders in a patient's cognitive functioning. The questionnaire consists a series of questions allowing the assessment of the following functions: 1) orientation in time and place, 2) attention/concentration, 3) short-term memory (recall), 4) language skills, 5) visual-spatial abilities, 6) ability to understand and follow the instructions. The maximum score that can be obtained on the test is 30 points. 27-30 is a correct result; 24-26 is a cognitive impairment without dementia; 19-23 mean mild dementia; 11-18 is a moderate degree dementia and 0-10 mean profound dementia.
July 3, 2023 until March 31, 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ariadna Łada-Maśko, Ph.D., Laboratory of Psychological and Educational Tests
  • Study Director: Urszula Sajewicz-Radtke, Ph.D., Laboratory of Psychological and Educational Tests
  • Principal Investigator: Bartosz M Radtke, Ph.D., Laboratory of Psychological and Educational Tests

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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