Development and Validation of the Polish Geriatric Core Set.

April 10, 2024 updated by: Agnieszka Sozanska, University of Rzeszow

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

800

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

  • Poland
    • Podkarpacie
      • Rzeszów, Podkarpacie, Poland, 35-959
        • University of Rzeszów
        • Contact:

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

No

Sampling Method

Probability Sample

Study Population

Elderly people aged 60 and over living in south-eastern Poland.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • age of respondents below 60 years;
  • lack of participant's consent to participate in the study;
  • severe cognitive impairment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICF Geriatric core set
Time Frame: 2024-04/2024-12
International Classification Functioning Disability and Health Geriatric core set comprehensive and short version
2024-04/2024-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data of the sample
Time Frame: 2024-04/2024-12
Sociodemographic data of the sample (eg.age, sex, education level, number of comorbidities, environmental factors)
2024-04/2024-12
Disability - WHODAS 2.0 v 36 item
Time Frame: 2024-04/2024-12

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).
2024-04/2024-12

Collaborators and Investigators

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

Sponsor

University of Rzeszow

Investigators

  • Principal Investigator: Agnieszka Sozańska, prof, University of Rzeszów

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 (Estimated)

April 15, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Core set geriatric ICF

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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