DementiaDAD-GrNCT05850715
Cross-cultural Adaptation of the Greek Version of Disability Assessment for Dementia
An observational study of Dementia, run by University of Thessaly at 1 site in Greece.
Trial summary
The main purpose of this study is primarily the translation and cross-cultural adaptation into Greek and then the investigation of validity and reliability in the Greek target population. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Disability Assessment for Dementia (DAD)
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 12 May 2023to 31 Aug 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 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include patients with dementia of good cognitive level and necessarily have a caregiver. Patients may also live independently or with relatives or in a public or private care facility.
Who may be able to join
- be diagnosed with any type of dementia
- have a carer
- have a good cognitive level
Who cannot join
- be end-stage or bedridden
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation, Cross-cultural Adaptation, Reliability and Validity of the Greek Version of the Disability Assessment for Dementia Scale (DAD-Gr)
The main purpose of this study is primarily the translation and cross-cultural adaptation into Greek and then the investigation of validity and reliability in the Greek target population.
Read the detailed description
Two investigators will do the translation into Greek, then a third person independent of the first two will translate the scale backward, i.e. into English. Then, the three investigators will meet with another independent investigator who is familiar with the field of Greek translations of foreign language rating scales. Thus, the final translation and Greek version of the scale will be created. Then, the process of finding the participants will begin and the first assessment with the scale will be carried out initially. After two days will take place reassessment for the reliability of the measurement tool. In order to find the validity of the scale in the Greek population, in the first assessment will be used also Katz index for Basic Activities of Daily Living and the Lawton scale for Instrumental Activities of Daily Living.
- Conditions
- Dementia
- Being tested
- Disability Assessment for Dementia (DAD)
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disability Assessment for Dementia (DAD)Diagnostic test
The scale consists of 40 items and assesses patients' independence in basic and instrumental activities. The scale is completed by the patient's caregiver with the assistance of the assessor-therapist.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Assessment for Dementia and change from baseline
The scale is completed by the patient's caregiver with the assistance of the assessor-therapist.
Measured: At baseline and after two days for checking the change and therefore the reliability. The score can range between 0 - 40, where 40 means complete independence in activities of daily living.
Secondary outcomes (2)
Katz index for Basic Activities of Daily Living
The scale consists of 6 questions and will be asked to the caregiver by the assessor.
Measured: At baseline. The score can range between 0 - 6, where 6 means complete independence in basic activities of daily living.
Lawton scale for Instrumental Activities of Daily Living
The scale consists of 8 questions and will be asked to the caregiver by the assessor.
Measured: At baseline.The score can range between 0 - 8 for women and 0 - 5 for men, where the highest scores means complete independence in basic activities of daily living.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start12 May 2023
- Primary completion5 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Marios Kyriakatis, University of Thessaly
- Investigators
- Thomas Besios, Dr., Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850715
- Sponsor's protocol ID
- 416, 30/3/2023
- Acronym
- DAD-Gr
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gelinas I, Gauthier L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther. 1999 Sep-Oct;53(5):471-81. doi: 10.5014/ajot.53.5.471.
PubMed 10500855Sanchez-Perez A, Lopez-Roig S, Perez AP, Gomez PP, Pastor MA, Pomares MH. Validation Study of the Spanish Version of the Disability Assessment for Dementia Scale. Medicine (Baltimore). 2015 Nov;94(44):e1925. doi: 10.1097/MD.0000000000001925.
PubMed 26554794Tozlu M, Cankurtaran M, Yavuz BB, Cankurtaran ES, Kutluer I, Erkek BM, Halil M, Ulger Z, Cosgun E, Ariogul S. Functional disability in Alzheimer disease: a validation study of the Turkish version of the disability assessment for dementia scale. J Geriatr Psychiatry Neurol. 2014 Dec;27(4):237-46. doi: 10.1177/0891988714532014. Epub 2014 Apr 24.
PubMed 24763071
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-cultural Adaptation, Reliability and Validity of the Greek Version of the Disability Assessment for Dementia Scale (DAD-Gr)
- ClinicalTrials.gov ID
- NCT05850715
- Acronym / sponsor ID
- DAD-Gr / 416, 30/3/2023
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 9 May 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.
The main purpose of this study is primarily the translation and cross-cultural adaptation into Greek and then the investigation of validity and reliability in the Greek target population.
Detailed description
Two investigators will do the translation into Greek, then a third person independent of the first two will translate the scale backward, i.e. into English. Then, the three investigators will meet with another independent investigator who is familiar with the field of Greek translations of foreign language rating scales. Thus, the final translation and Greek version of the scale will be created. Then, the process of finding the participants will begin and the first assessment with the scale will be carried out initially. After two days will take place reassessment for the reliability of the measurement tool. In order to find the validity of the scale in the Greek population, in the first assessment will be used also Katz index for Basic Activities of Daily Living and the Lawton scale for Instrumental Activities of Daily Living.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients with dementia of good cognitive level and necessarily have a caregiver. Patients may also live independently or with relatives or in a public or private care facility.
Key inclusion criteria (3 listed)
- be diagnosed with any type of dementia
- have a carer
- have a good cognitive level
Key exclusion criteria (1 listed)
- be end-stage or bedridden
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disability Assessment for Dementia (DAD)The scale consists of 40 items and assesses patients' independence in basic and instrumental activities. The scale is completed by the patient's caregiver with the assistance of the assessor-therapist. | Diagnostic test | – |
Primary outcome
Disability Assessment for Dementia and change from baseline
Time frame: At baseline and after two days for checking the change and therefore the reliability. The score can range between 0 - 40, where 40 means complete independence in activities of daily living.
The scale is completed by the patient's caregiver with the assistance of the assessor-therapist.
2 secondary outcomes
Katz index for Basic Activities of Daily Living
Time frame: At baseline. The score can range between 0 - 6, where 6 means complete independence in basic activities of daily living.
Lawton scale for Instrumental Activities of Daily Living
Time frame: At baseline.The score can range between 0 - 8 for women and 0 - 5 for men, where the highest scores means complete independence in basic activities of daily living.
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 6 Dec 2023.
- Background: PubMed 10500855Gelinas I, Gauthier L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther. 1999 Sep-Oct;53(5):471-81. doi: 10.5014/ajot.53.5.471.
- Background: PubMed 26554794Sanchez-Perez A, Lopez-Roig S, Perez AP, Gomez PP, Pastor MA, Pomares MH. Validation Study of the Spanish Version of the Disability Assessment for Dementia Scale. Medicine (Baltimore). 2015 Nov;94(44):e1925. doi: 10.1097/MD.0000000000001925.
- Background: PubMed 24763071Tozlu M, Cankurtaran M, Yavuz BB, Cankurtaran ES, Kutluer I, Erkek BM, Halil M, Ulger Z, Cosgun E, Ariogul S. Functional disability in Alzheimer disease: a validation study of the Turkish version of the disability assessment for dementia scale. J Geriatr Psychiatry Neurol. 2014 Dec;27(4):237-46. doi: 10.1177/0891988714532014. Epub 2014 Apr 24.
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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.
Thomas Besios, Dr. study director
Assistant Professor
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 Dementia, run by University of Thessaly at 1 site in Greece.
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 1 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 6 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 Greece. 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?
Disability Assessment for Dementia and change from baseline (time frame: At baseline and after two days for checking the change and therefore the reliability. The score can range between 0 - 40, where 40 means complete independence in activities of daily living.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850715, which also lists 3 linked publications.
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 6 Dec 2023.