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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05850715
Other study ID # 416, 30/3/2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2023
Est. completion date August 31, 2023

Study information

Verified date November 2023
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 31, 2023
Est. primary completion date June 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
Greece University of Thessaly Lamía Fthiotis

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disability Assessment for Dementia and change from baseline 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 Katz index for 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.
Secondary Lawton scale for Instrumental 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.
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