- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05850715
Cross-cultural Adaptation of the Greek Version of Disability Assessment for Dementia (DAD-Gr)
November 29, 2023 updated by: Georgios Marios Kyriakatis, University of Thessaly
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fthiotis
-
Lamía, Fthiotis, Greece, 35100
- University of Thessaly
-
-
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
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- be diagnosed with any type of dementia
- have a carer
- have a good cognitive level
Exclusion Criteria:
- be end-stage or bedridden
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 |
|---|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
The scale consists of 6 questions and will be asked to the caregiver by the assessor.
|
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.
|
The scale consists of 8 questions and will be asked to the caregiver by the assessor.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Thomas Besios, Dr., Assistant Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Sanchez-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.
- Tozlu 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.
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)
May 12, 2023
Primary Completion (Actual)
June 5, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
March 31, 2023
First Submitted That Met QC Criteria
April 28, 2023
First Posted (Actual)
May 9, 2023
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 416, 30/3/2023
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.
Clinical Trials on Dementia
-
Benjamin Rose Institute on AgingNational Institute on Aging (NIA)RecruitingMild Dementia | Moderate DementiaUnited States
-
Yaolin PeiNational Institutes of Health (NIH)RecruitingEnd of Life Decision Making | Dementia Caregivers | Advanced DementiaUnited States
-
Benuvia Therapeutics Inc.MandaraNot yet recruiting
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityCompletedDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeActive, not recruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
The University of Hong KongNot yet recruiting
-
Temple UniversityCompletedDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
Clinical Trials on Disability Assessment for Dementia (DAD)
-
Hospices Civils de LyonRecruiting
-
Second Affiliated Hospital, School of Medicine,...Recruiting
-
Hasselt UniversityJessa HospitalCompletedHip Pain Chronic | Musculoskeletal Pain | Neck Pain | Low Back Pain, Recurrent | Shoulder Pain | PROMs | Fear of Pain | Musculoskeletal Pain Disorder | Knee Pain Chronic | Fear of InjuryBelgium
-
Gulhane Training and Research HospitalRecruitingDelirium in Old Age | Delirium Superimposed on Dementia | Delirium With DementiaTurkey
-
Cumhuriyet UniversityRecruitingDepression | Sleep | Anxiety | Pain, Chronic | Sleep Hygiene | Coccyx InjuriesTurkey
-
The Hong Kong Polytechnic UniversityCompletedDementia | Alzheimer DiseaseHong Kong
-
Kovacs FoundationTerminated
-
University of WashingtonNational Institute of Nursing Research (NINR)CompletedPhysical DisabilityUnited States
-
Mackay Medical CollegeEnrolling by invitation
-
Icahn School of Medicine at Mount SinaiNational Institute on Aging (NIA)Completed