NCT06197451

Brief Summary

The purpose of this study is to M.D. Validity of the Turkish version of the Anderson Dysphagia Inventory for the Turkish population, reliability, and cultural adaptation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 17, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

December 19, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2024

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 17, 2023

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Turkish Version of M. D. Anderson Dysphagia Inventory

    The M.D Anderson Dysphagia Inventory is a self-administered, psychometrically validated dysphagia-specific questionnaire for cancer patients that is designed to assess the impact of dysphagia on health-related quality of life . Like the original English version, the validated Turkish translation of the M.D. Anderson Dysphagia Inventory consists of 20 items pooled in 4 subscales: the global scale (1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items)The global question was scored individually, and the mean score of each subscale (emotional, physical, and functional) was multiplied by 20 to obtain a total score with a range from zero (extremely low functioning) to 100 (high functioning). A higher M. D. Anderson Dysphagia Inventory score is indicative of better day-to-day functioning and quality of life.

    Baseline

  • Turkish Version of M. D. Anderson Dysphagia Inventory

    The M.D Anderson Dysphagia Inventory is a self-administered, psychometrically validated dysphagia-specific questionnaire for cancer patients that is designed to assess the impact of dysphagia on health-related quality of life . Like the original English version, the validated Turkish translation of the M.D. Anderson Dysphagia Inventory consists of 20 items pooled in 4 subscales: the global scale (1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items)The global question was scored individually, and the mean score of each subscale (emotional, physical, and functional) was multiplied by 20 to obtain a total score with a range from zero (extremely low functioning) to 100 (high functioning). A higher M. D. Anderson Dysphagia Inventory score is indicative of better day-to-day functioning and quality of life.

    Two weeks

Secondary Outcomes (1)

  • The Swallowing Quality-of-Life Questionnaire

    Baseline

Other Outcomes (1)

  • Subject Demographics and Medical History

    Baseline

Study Arms (2)

1

Patients who are diagnosed with neurologic disorders The first group consists of 170 diagnosed with neurologic disorders who have at least six months of dysphagia complaints. The participants will given the Turkish version of M.D. Anderson Dysphagia Inventory, consisted of 20 questions, Swallowing Quality-of-Life Questionnaire and Mini Mental Questionnaire. After the two weeks, 50 participants will given the MDADI for sampling.

Other: Turkish Version of M. D. Anderson Dysphagia Inventory

2

Healthy subjects The second group consists of 50 healty participants will given the MDADI consists of 20 questions and Swallowing Quality-of-Life Questionnaire.

Other: Turkish Version of M. D. Anderson Dysphagia Inventory

Interventions

Turkish Validation and Cultural Adaptation of M. D. Anderson Dysphagia Inventory in Neurologic Patients

12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with diagnosed with neurologic disorder and having oropharyngeal dysphagia and healthy adults

You may qualify if:

  • Group 1:
  • Diagnosed with neurologic disorder
  • Able to speak, read, understand and write in Turkish
  • History of dysphagia during 6 months
  • Group 2:
  • Able to speak, read, understand and write in Turkish
  • Healthy adults

You may not qualify if:

  • Mini Mental State Examination score below 23 points
  • History of head and neck cancer (HNC),
  • Age below 18 or above 85 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500

Ankara, 06500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Deglutition DisordersNervous System Diseases

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Muserrefe Nur Keles, PhD

    Gazi University

    STUDY CHAIR

Central Study Contacts

Muserrefe Nur Keles, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 9, 2024

Study Start

December 19, 2023

Primary Completion

February 19, 2024

Study Completion

May 19, 2024

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations