AgingNCT06365996
Development and Validation of the Polish Geriatric Core Set.
An observational study of Aging, run by University of Rzeszow at 1 site in Poland.
Trial summary
Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging
- How many people
- 800 participants
- Where
- 1 sitePoland
- Study dates
- 15 Apr 2024to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly people aged 60 and over living in south-eastern Poland.
Who may be able to join
- age of respondents 60 years and older;
- informed and voluntary consent of the participant to participate in the study;
- cognitive condition enabling conducting a reliable interview regarding the current health situation and functioning of the subject.
Who cannot join
- age of respondents below 60 years;
- lack of participant's consent to participate in the study;
- severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Rzeszow
Rzeszów, Podkarpackie Voivodeship, 35-959
Agnieszka Sozańska, professor, 530172857, asozanska@ur.edu.pl
About this study
Official title: Development and Validation of the Polish Version of the Geriatric Categorical Profile Based on ICF.
Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people.
Read the detailed description
Introduction: In Poland, as in many developed countries, the demographic structure of the population is changing due to the ageing of the population. As people grow older, involutionary changes intensify, and the often accompanying multimorbidity leads to deterioration in the functional capacity of the elderly. An additional problem for older people is reduced emotional state and reduced quality of life, as well as cognitive impairment. A very important element affecting the functioning of older people is their living environment, both physical and social. All these elements affect the functioning and disability of older people.
The World Health Organisation (WHO) has created the International Classification of Functioning, Disability and Health (ICF) based on a comprehensive biopsychosocial approach to the patient, on the basis of which WHO experts prepare categorical sets that allow a comprehensive assessment of people with different problems. One such set is the categorical profile (expanded and shortened version) prepared for the comprehensive assessment of older people (Geriatrics Comprehensive and Bref Core sets). The World Health Organisation encourages the use of the ICF and categorical profiles by all member countries. In Poland, this profile has not yet been adopted and validated.
The aim of this study is to culturally adapt and validate the Polish version of the ICF-based categorical profile for the assessment of older people. Mapping tools to the profile. Assessment of older people using the prepared tool.
Material and method: a minimum of 800 people aged 65 and over are planned to be included in the study. The project will be carried out in stages:
I preparation of the Polish version of the categorical profile for assessing older people and cultural adaptation of the tool. The cultural adaptation will consist of verifying the categories included in the categorical profile for assessing older people; II Mapping the tools/questions for assessing the different ICF categories included in the first version of the categorical profile.
III Conducting a survey using the tools mapped to the core set among older people in order to validate the constructed categorical profile and make the necessary adjustments to the toolkit and profile categories. The actual survey will be carried out by means of a face-to-face interview and a physical survey; IV Cross-sectional study conducted in the Podkarpackie Voivodeship to assess the health and functioning of older people using the prepared categorical profile with the mapped tools.
- Conditions
- Aging
- Keywords
- aging, aged, ICF, disability
What is being measured
The primary outcome is the main question the study is designed to answer.
ICF Geriatric core set
International Classification Functioning Disability and Health Geriatric core set comprehensive and short version
Measured: 2024-04/2024-12
Secondary outcomes (2)
Sociodemographic data of the sample
Sociodemographic data of the sample (eg.age, sex, education level, number of comorbidities, environmental factors)
Measured: 2024-04/2024-12
Disability - WHODAS 2.0 v 36 item
The 36-item WHODAS 2.0 is used to measure general disability and disability in six domains:
Do1 Cognition (6 items), Do2 Mobility (5 items), Do3 Self-care (4 items), Do4 Getting along (5 items), Do5 Life activities (8 items), and Do6 Participation (8 items). During the interview, the response refers to the last 30 days. Answers to the questions are rated on a 5-point scale identifying the level of di culty or problem (1 = none; 2 = mild; 3 = moderate; 4 = severe; 5 = extreme or cannot to do).
Measured: 2024-04/2024-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Sozanska, University of Rzeszow
- Investigators
- Agnieszka Sozańska, prof, Principal investigator, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365996
- Sponsor's protocol ID
- Core set geriatric ICF
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Polish Version of the Geriatric Categorical Profile Based on ICF.
- ClinicalTrials.gov ID
- NCT06365996
- Acronym / sponsor ID
- Core set geriatric ICF
- Conditions
- Aging
- Keywords
- aging, aged, ICF, disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people.
Detailed description
Introduction: In Poland, as in many developed countries, the demographic structure of the population is changing due to the ageing of the population. As people grow older, involutionary changes intensify, and the often accompanying multimorbidity leads to deterioration in the functional capacity of the elderly. An additional problem for older people is reduced emotional state and reduced quality of life, as well as cognitive impairment. A very important element affecting the functioning of older people is their living environment, both physical and social. All these elements affect the functioning and disability of older people.
The World Health Organisation (WHO) has created the International Classification of Functioning, Disability and Health (ICF) based on a comprehensive biopsychosocial approach to the patient, on the basis of which WHO experts prepare categorical sets that allow a comprehensive assessment of people with different problems. One such set is the categorical profile (expanded and shortened version) prepared for the comprehensive assessment of older people (Geriatrics Comprehensive and Bref Core sets). The World Health Organisation encourages the use of the ICF and categorical profiles by all member countries. In Poland, this profile has not yet been adopted and validated.
The aim of this study is to culturally adapt and validate the Polish version of the ICF-based categorical profile for the assessment of older people. Mapping tools to the profile. Assessment of older people using the prepared tool.
Material and method: a minimum of 800 people aged 65 and over are planned to be included in the study. The project will be carried out in stages:
I preparation of the Polish version of the categorical profile for assessing older people and cultural adaptation of the tool. The cultural adaptation will consist of verifying the categories included in the categorical profile for assessing older people; II Mapping the tools/questions for assessing the different ICF categories included in the first version of the categorical profile.
III Conducting a survey using the tools mapped to the core set among older people in order to validate the constructed categorical profile and make the necessary adjustments to the toolkit and profile categories. The actual survey will be carried out by means of a face-to-face interview and a physical survey; IV Cross-sectional study conducted in the Podkarpackie Voivodeship to assess the health and functioning of older people using the prepared categorical profile with the mapped tools.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly people aged 60 and over living in south-eastern Poland.
Key inclusion criteria (3 listed)
- age of respondents 60 years and older;
- informed and voluntary consent of the participant to participate in the study;
- cognitive condition enabling conducting a reliable interview regarding the current health situation and functioning of the subject.
Key exclusion criteria (3 listed)
- age of respondents below 60 years;
- lack of participant's consent to participate in the study;
- severe cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICF Geriatric core set
Time frame: 2024-04/2024-12
International Classification Functioning Disability and Health Geriatric core set comprehensive and short version
2 secondary outcomes
Sociodemographic data of the sample
Time frame: 2024-04/2024-12
Disability - WHODAS 2.0 v 36 item
Time frame: 2024-04/2024-12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Sozańska, prof principal investigator
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Sozańska, prof. (530172857, asozanska@ur.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICF Geriatric core set (time frame: 2024-04/2024-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.