NCT04477174

Brief Summary

Purpose of the study is the validity and reliability of the Turkish version of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an assessment tool for dysphagia patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

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

July 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

July 15, 2020

Last Update Submit

December 26, 2020

Conditions

Swallowing DisorderValidationPharyngeal Dysphagia

Keywords

PharyngealresidueswallowscaleYale

Outcome Measures

Primary Outcomes (1)

  • Validation of Pharyngeal Residue Severity Rating Scale

    To match between Fiberoptic Endoscopic Evaluation of Swallowing Images with Yale Pharyngeal Residue Severity Rating Scale Scores by health professionals. High match scores give high reliability, low match scores give low reliability. Match scores were compared and evaluated as statistically. High match score is better, low score is worse.

    2 months

Study Arms (2)

Group A

Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. After 2 weeks, the participants match again.

Group B

Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health professionals

You may qualify if:

  • years
  • at least having undergraduate education on health profession
  • agree to participant

You may not qualify if:

  • out of age 18-70 years
  • out of having undergraduate education
  • mental disorder
  • cognitive limitations
  • visual limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Melis Ece Arkan Ararat, MD

    University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital

    PRINCIPAL INVESTIGATOR

  • Ugur Uygan, MD

    University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

July 15, 2020

Primary Completion

September 15, 2020

Study Completion

September 15, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)