NCT05850715

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 12, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

24 days

First QC Date

March 31, 2023

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Katz index for Basic Activities of Daily Living

    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

    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.

Interventions

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.

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • be diagnosed with any type of dementia
  • have a carer
  • have a good cognitive level

You may not qualify if:

  • be end-stage or bedridden

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Lamia, Fthiotis, 35100, Greece

Location

Related 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.

    PMID: 10500855BACKGROUND
  • 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.

    PMID: 26554794BACKGROUND
  • 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.

    PMID: 24763071BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Thomas Besios, Dr.

    Assistant Professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Undergraduate Student, Department of Physiothrapy, School of Health Sciences

Study Record Dates

First Submitted

March 31, 2023

First Posted

May 9, 2023

Study Start

May 12, 2023

Primary Completion

June 5, 2023

Study Completion

August 31, 2023

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations