Cognitive DysfunctionNCT06059768
Urdu Translation and Psychometric Analysis of Lawton IADLS.
An observational study of Cognitive Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
Functional capacity and independent living skills are most crucial and important aspects to measure in older adults. Lawton IADL is an 8-item scale used to assess independent living skills. Lawton IADLS was originally developed in English. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Dec 2023
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects with above mentioned inclusion criteria will be taken. Written informed consent will be obtained from all participants. After obtaining demographic data all the participants will be asked to perform Lawton IADLs on the instruction and on completion performance will be scored.
Who may be able to join
- Age between 65-75 years
- Both gender Male and Female
- Sufficient cognitive ability to understand and read the questionnaire with
- MMSE 24 or more.
- Fluent in Urdu Language
Who cannot join
- Patients with neurological problems affecting their IADLs
- Cognitive/communication impairment.
- Patients with musculoskeletal impairments affecting IADLs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urdu Translation and Psychometric Analysis of Lawton Instrumental Activities of Daily Living Scale.
Functional capacity and independent living skills are most crucial and important aspects to measure in older adults. Lawton IADL is an 8-item scale used to assess independent living skills. Lawton IADLS was originally developed in English. It has been translated and validated in several languages and showed excellent reliability and responsiveness. In our study Lawton IADL scale will be translated in Urdu and its psychometric analysis will be performed.The study design will be descriptive translation study. Study will be conducted in Rahimoon Welfare Foundation old age home of Lahore. Inclusion criteria will be patients of age between 65-75 years with both genders scoring 24 or more on MMSE and those who will be fluent in Urdu language. Those patients will be excluded who will have neurological problems affecting their IADLS, Cognitive/communication dysfunction or Patients with musculoskeletal impairments affecting IADLs. Participants will be asked to perform Lawton IADLs on the instruction and on completion performance will be scored. Study will be completed in two phases. Phase I will consist of Translation of original version (English) into Urdu version and pilot-testing of translated version. In phase II psychometric analysis will be performed. Data will be analyzed using SPSS version 21.
Read the detailed description
Aging is a constant, natural and inevitable process in living creatures' lives, characterized by bio psychosocial and cultural changes that are affected by intrinsic factors such as genetics and by extrinsic factors such as acquired experiences and the environment (World Health Organization [WHO], 2010).
Geriatrics refers to medical care for older adults, there is no set age to define older age, but age greater than 65 is mostly used. The elderly, or those older than 65 years, currently represent 12.5 percent of the U.S. population.With increasing life spans across the world, Pakistan is also experiencing a rise in its elderly population.According to 1998 Census report, in Pakistan the population of over-60 years increased to 7.34 million .Functional capacity is a complex concept that includes basic activities of daily living (BADL), instrumental activities of daily living (IADL),and advanced activities.BADL demonstrate the effectiveness of rehabilitation, and determine a person's ability to perform activities of daily living.The BADL may decline due to age, a specific disease, or a variety of factors such as decreased muscle strength, loss of vision, and postural changes Functional decline in older people is nearly 12% in those more than 75 years of age. According to (ECHP) people over 65 in the European Community, it is observed that 21% of the population is severely deteriorated to carry out activities of daily living, and this figure rises up to 29% for people over 75 years old. France would be the European country with most dependence in the ADL (28% of people over 65). The estimate of prevalence of physical disability in older adults of Punjab Pakistan varied from 13.9% to 36.6%.The assessment of functional status is critical when caring for older adults. A functional assessment can also guide the clinician to focus on the person's baseline capabilities, facilitating early recognition of changes that may signify a need either for additional resources or for a medical work-up. number of questionnaires are available to assess IADL, however, no gold standard exists . One of the most widely used is the Lawton Instrumental Activities of Daily Living Scale developed in 1969 by Lawton and Broady. Lawton IADL is an 8-item scale used to assess independent living skills. It is most useful for identifying how a person is functioning at a present time and to identify improvement or deterioration over time.
- Conditions
- Cognitive Dysfunction
- Keywords
- Cognitive Dysfunction, Geriatrics, Psychometric, Validity
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Lawton IADL
It is an 8-item scale used to assess independent living skills. It is most useful for identifying how a person is functioning at a present time and to identify improvement or deterioration over time. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent).Total administration time is 10-15 minutes
Measured: 8 months
Functional Activities Questionnaire
It is a 10 item scale used to measures instrumental activities of daily living scale in older adults. This instrument also measures functional changes over the period of time. Participants respond to 10-items to daily tasks needed when living independently. A scale ranging from independence (0) to dependence (3) is used for responses. Approximately 10 minutes are required for test completion.
Measured: 8 months
Secondary outcomes (2)
Reliability of translated version of Lawton IADLS
The reliability of translated version of Lawton IADLS will be determined by assessing test-retest reliability across repeated measures and internal consistency through crohnbach alpha.
Measured: 8 months
Validity of translated version of Lawton IADLS
Validity is how accurate the results are. Validity of translated version of Lawton IADLS will be determined by assessing face validity by percentage agreement, content validity by CVI and criterion/concurrent validity by Pearson's correlation between Lawton IADLS and FAQ (functional activity questionnaire)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rida Maryaum, MSPT-NM, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059768
- Sponsor's protocol ID
- RiphahIU Rida Maryaum
- Status last verified
- Dec 2023
- First submitted
- 22 Sep 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation and Psychometric Analysis of Lawton Instrumental Activities of Daily Living Scale.
- ClinicalTrials.gov ID
- NCT06059768
- Acronym / sponsor ID
- RiphahIU Rida Maryaum
- Conditions
- Cognitive Dysfunction
- Keywords
- Cognitive Dysfunction, Geriatrics, Psychometric, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 29 Sep 2023 (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.
Functional capacity and independent living skills are most crucial and important aspects to measure in older adults. Lawton IADL is an 8-item scale used to assess independent living skills. Lawton IADLS was originally developed in English. It has been translated and validated in several languages and showed excellent reliability and responsiveness. In our study Lawton IADL scale will be translated in Urdu and its psychometric analysis will be performed.The study design will be descriptive translation study. Study will be conducted in Rahimoon Welfare Foundation old age home of Lahore. Inclusion criteria will be patients of age between 65-75 years with both genders scoring 24 or more on MMSE and those who will be fluent in Urdu language. Those patients will be excluded who will have neurological problems affecting their IADLS, Cognitive/communication dysfunction or Patients with musculoskeletal impairments affecting IADLs. Participants will be asked to perform Lawton IADLs on the instruction and on completion performance will be scored. Study will be completed in two phases. Phase I will consist of Translation of original version (English) into Urdu version and pilot-testing of translated version. In phase II psychometric analysis will be performed. Data will be analyzed using SPSS version 21.
Detailed description
Aging is a constant, natural and inevitable process in living creatures' lives, characterized by bio psychosocial and cultural changes that are affected by intrinsic factors such as genetics and by extrinsic factors such as acquired experiences and the environment (World Health Organization [WHO], 2010).
Geriatrics refers to medical care for older adults, there is no set age to define older age, but age greater than 65 is mostly used. The elderly, or those older than 65 years, currently represent 12.5 percent of the U.S. population.With increasing life spans across the world, Pakistan is also experiencing a rise in its elderly population.According to 1998 Census report, in Pakistan the population of over-60 years increased to 7.34 million .Functional capacity is a complex concept that includes basic activities of daily living (BADL), instrumental activities of daily living (IADL),and advanced activities.BADL demonstrate the effectiveness of rehabilitation, and determine a person's ability to perform activities of daily living.The BADL may decline due to age, a specific disease, or a variety of factors such as decreased muscle strength, loss of vision, and postural changes Functional decline in older people is nearly 12% in those more than 75 years of age. According to (ECHP) people over 65 in the European Community, it is observed that 21% of the population is severely deteriorated to carry out activities of daily living, and this figure rises up to 29% for people over 75 years old. France would be the European country with most dependence in the ADL (28% of people over 65). The estimate of prevalence of physical disability in older adults of Punjab Pakistan varied from 13.9% to 36.6%.The assessment of functional status is critical when caring for older adults. A functional assessment can also guide the clinician to focus on the person's baseline capabilities, facilitating early recognition of changes that may signify a need either for additional resources or for a medical work-up. number of questionnaires are available to assess IADL, however, no gold standard exists . One of the most widely used is the Lawton Instrumental Activities of Daily Living Scale developed in 1969 by Lawton and Broady. Lawton IADL is an 8-item scale used to assess independent living skills. It is most useful for identifying how a person is functioning at a present time and to identify improvement or deterioration over time.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects with above mentioned inclusion criteria will be taken. Written informed consent will be obtained from all participants. After obtaining demographic data all the participants will be asked to perform Lawton IADLs on the instruction and on completion performance will be scored.
Key inclusion criteria (5 listed)
- Age between 65-75 years
- Both gender Male and Female
- Sufficient cognitive ability to understand and read the questionnaire with
- MMSE 24 or more.
- Fluent in Urdu Language
Key exclusion criteria (3 listed)
- Patients with neurological problems affecting their IADLs
- Cognitive/communication impairment.
- Patients with musculoskeletal impairments affecting IADLs
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
Lawton IADL
Time frame: 8 months
It is an 8-item scale used to assess independent living skills. It is most useful for identifying how a person is functioning at a present time and to identify improvement or deterioration over time. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent).Total administration time is 10-15 minutes
Functional Activities Questionnaire
Time frame: 8 months
It is a 10 item scale used to measures instrumental activities of daily living scale in older adults. This instrument also measures functional changes over the period of time. Participants respond to 10-items to daily tasks needed when living independently. A scale ranging from independence (0) to dependence (3) is used for responses. Approximately 10 minutes are required for test completion.
2 secondary outcomes
Reliability of translated version of Lawton IADLS
Time frame: 8 months
Validity of translated version of Lawton IADLS
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Rida Maryaum, MSPT-NM principal investigator
Riphah International University
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 Cognitive Dysfunction, run by Riphah International University at 1 site in Pakistan.
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 5 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: finished, as of the sponsor's last update on 29 Dec 2023. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lawton IADL (time frame: 8 months). The study lists 2 primary outcomes in all. 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 29 Dec 2023.