NCT04296409

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

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 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

March 3, 2020

Last Update Submit

January 3, 2024

Conditions

Swallowing Disorder

Outcome Measures

Primary Outcomes (1)

  • Turkish Deglutition Handicap Index

    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 Outcomes (1)

  • The Turkish version of the Eating Assessment Tool-10

    3 months

Study Arms (1)

Adult patients with swallowing disorders

Swallowing function will be evaluated with the Turkish Deglutition Handicap Index, and Turkish version of the Eating Assessment Tool.

Other: Turkish Deglutition Handicap Index

Interventions

Turkish Deglutition Handicap IndexOTHER

Swallowing function will be evaluated by the Turkish Deglutition Handicap Index.

Adult patients with swallowing disorders

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with swallowing difficulties

You may qualify if:

  • Willing to participate
  • Having swallowing problems

You may not qualify if:

  • Being under the age of 20 years, and above the age of 60 years
  • Not willing to participate
  • Having no swallowing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • SELEN SEREL ARSLAN

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

June 22, 2022

Primary Completion

February 22, 2023

Study Completion

February 22, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)