Swallowing DisorderNCT03907566
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
An observational study of Swallowing Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients with swallowing disorders. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Swallowing Disorder
- What is being tested?
- The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Sep 2019
- 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 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Adult patients with swallowing concerns
Who may be able to join
- Willing to participate
- Having swallowing problems
Who cannot join
- Being under the age of 20 years, and above the age of 60 years
- Not willing to participate
- No swallowing problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Turkish Version of the Oropharyngeal Dysphagia Screening Test for Patients and Professionals
The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients with swallowing disorders.
Read the detailed description
The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals 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 The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals and Turkish Eating Assessment Tool.
- Conditions
- Swallowing Disorder
- Being tested
- The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and ProfessionalsOther
Swallowing function will be evaluated by the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with swallowing disorders | Swallowing function will be evaluated with the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals, and Turkish version of the Eating Assessment Tool. Receives: Other: The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
This instrument is used to evaluate swallowing function. The test consists of 18 four points Likert-type items, organized assessing 3 scales: Safety, Efficacy, and Others. In most of the items, the Likert scale ranged from 1 = Never to 4 = Very often. The test score ranges from 18 (minimum) to 72 (maximum) points.
Measured: 3 months
Secondary outcomes (1)
The Turkish version of the Eating Assessment Tool-10
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 May 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELEN SEREL ARSLAN, Hacettepe University
- Investigators
- SELEN SEREL ARSLAN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907566
- Sponsor's protocol ID
- Dysphagia screening
- Status last verified
- Jan 2024
- First submitted
- 5 Apr 2019
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Version of the Oropharyngeal Dysphagia Screening Test for Patients and Professionals
- ClinicalTrials.gov ID
- NCT03907566
- Acronym / sponsor ID
- Dysphagia screening
- Conditions
- Swallowing Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 9 Apr 2019 (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 purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients with swallowing disorders.
Detailed description
The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals 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 The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals and Turkish Eating Assessment Tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with swallowing disorders | – | Other: The Turkish Oropharyngeal Dysphagia Screening Test for Patients and ProfessionalsSwallowing function will be evaluated with the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals, and Turkish version of the Eating Assessment Tool. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with swallowing concerns
Key inclusion criteria (2 listed)
- Willing to participate
- Having swallowing problems
Key exclusion criteria (3 listed)
- Being under the age of 20 years, and above the age of 60 years
- Not willing to participate
- No swallowing problems
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 |
|---|---|---|
| The Turkish Oropharyngeal Dysphagia Screening Test for Patients and ProfessionalsSwallowing function will be evaluated by the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals | Other | Adult patients with swallowing disorders |
Primary outcome
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
Time frame: 3 months
This instrument is used to evaluate swallowing function. The test consists of 18 four points Likert-type items, organized assessing 3 scales: Safety, Efficacy, and Others. In most of the items, the Likert scale ranged from 1 = Never to 4 = Very often. The test score ranges from 18 (minimum) to 72 (maximum) points.
1 secondary outcome
The Turkish version of the Eating Assessment Tool-10
Time frame: 3 months
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 5 Jan 2024.
- Individual participant dataSharing planned: No
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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.
SELEN SEREL ARSLAN principal investigator
Hacettepe University
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 Swallowing Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 5 Jan 2024. 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 Turkey (Türkiye). 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?
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.