- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296409
The Turkish Deglutition Handicap Index
January 3, 2024 updated by: SELEN SEREL ARSLAN, Hacettepe University
The Turkish Version of the Deglutition Handicap Index
The purpose of this study is to test the reliability and validity of the The Turkish Deglutition Handicap Index among adult patients with swallowing disorders.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to test the reliability and validity of the The Turkish Deglutition Handicap Index among adult patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of the instrument will be investigated.
The internal consistency will be assessed using Cronbach's alpha.
Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability.
The criterion validity of the scale will be determined by assessing the correlation between The Turkish Deglutition Handicap Index and Turkish Eating Assessment Tool.
Study Type
Observational
Enrollment (Actual)
100
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
-
-
-
Ankara, Turkey, 06100
- Hacetttepe University
-
-
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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients with swallowing difficulties
Description
Inclusion Criteria:
- Willing to participate
- Having swallowing problems
Exclusion Criteria:
- Being under the age of 20 years, and above the age of 60 years
- Not willing to participate
- Having no swallowing problems
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult patients with swallowing disorders
Swallowing function will be evaluated with the Turkish Deglutition Handicap Index, and Turkish version of the Eating Assessment Tool.
|
Swallowing function will be evaluated by the Turkish Deglutition Handicap Index.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turkish Deglutition Handicap Index
Time Frame: 3 months
|
Turkish Deglutition Handicap Index is a swallowing function evaluation tool.
The test consists of 30 items which will be scored between 0 to 4. 0 means Never, and 4 means Always.
The test score ranges from 30 (minimum) to 120 (maximum) points.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Turkish version of the Eating Assessment Tool-10
Time Frame: 3 months
|
The Turkish version of the Eating Assessment Tool-10 is a self-reporting instrument with 10 questions.
Total score ranges between 0 to 40.
Higher scores indicate worse swallowing function.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SELEN SEREL ARSLAN, Hacettepe University
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)
June 22, 2022
Primary Completion (Actual)
February 22, 2023
Study Completion (Actual)
February 22, 2023
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 4, 2020
First Posted (Actual)
March 5, 2020
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 3, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dysphagia evaluation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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