DysphagiaNCT06197451
Validity and Reliability of a Turkish Version of MD Anderson Inventory Dysphagia Inventory
An observational study of Dysphagia and Neurologic Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Neurologic Disorder
- What is being tested?
- Turkish Version of M. D. Anderson Dysphagia Inventory
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2023to 19 May 2024
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with diagnosed with neurologic disorder and having oropharyngeal dysphagia and healthy adults
Who may be able to join
- 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
Who cannot join
- Mini Mental State Examination score below 23 points
- History of head and neck cancer (HNC),
- Age below 18 or above 85 years.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
Ankara, 06500
Muserref KELES, PhD, 5426622464 ext. +90, muserref-1@hotmail.com
About this study
Official title: Validity and Reliability of a Turkish Version of MD Anderson Dysphagia Inventory for Neurogenic Patients
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.
Read the detailed description
Oropharyngeal dysphagia (OD) is a common finding in patients with neurogenic disorders.
Swallowing disorder can be acute or chronic in nature. For example, acute OD is observed in patients after stroke, head trauma, neurosurgical intervention, or in patients with Guillain-Barré syndrome. Chronic OD may develop in patients who do not recover after a stroke. Degenerative OD, Parkinson's disease, amyotrophic lateral sclerosis, myasthenia gravis, Huntington's disease, myotonic dystrophy type 1 and multiple sclerosis It is seen in patients with progressive neurological diseases. The prevalence of OD in neurogenic patients varies from 3% to 50% in stroke patients and up to almost 100% in patients with Huntington's disease. The OD can lead to weight loss, malnutrition, social isolation, aspiration pneumonia, and reduced health-related quality of life (QoL). Some studies have reported that dysphagia-specific QoL is weakly associated with OD severity measured using, among other things, fiberoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopy of swallowing (VFS). Therefore, dysphagia-specific QoL questionnaires used alongside these instrumental assessments add value by providing insight into patients' perception of OD, which can be taken into account in the treatment plan. There are dysphagia-specific quality-of-life questionnaires that are actively used today: Swallowing Quality of Life Questionnaire (SWAL-QOL, 44 items), Swallowing Disability Index (30 items), Dysphagia Handicap Index (25 items) and M.D. Anderson Dysphagia Inventory (MDADI, 20 items). Multidisciplinary dysphagia clinics in our country mostly focus on the head and neck. It is visited by patients with OD of oncological or neurological origin.The M. D. Anderson dysphagia inventory is an easier inventory to perform since it has a smaller number of questions and contains more standard questions compared to other currently used questionnaires. Other questionnaires, such as the SWAL-QOL-TR and the Swallowing Disability Index, are longer than the MDADI and take more time to complete. The purpose of this study is M.D. Validity of the Turkish version of the Anderson Dysphagia Inventory for the Turkish population, reliability and cultural adaptation.
- Conditions
- Dysphagia, Neurologic Disorder
- Being tested
- Turkish Version of M. D. Anderson Dysphagia Inventory
- Medical subject headings
- Deglutition Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of M. D. Anderson Dysphagia InventoryOther
Turkish Validation and Cultural Adaptation of M. D. Anderson Dysphagia Inventory in Neurologic Patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Turkish Version of M. D. Anderson Dysphagia Inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two weeks
Secondary outcomes (1)
The Swallowing Quality-of-Life Questionnaire
The Swallowing Quality-of-Life Questionnaire was designed to evaluate the impact of dysphagia on health-related quality of life in dysphagic patients. It consists of 44 items divided among 11 domains: general burden (2 items); food selection (2 items); eating duration (2 items); eating desire (3 items); fear of eating (4 items); sleep (2 items); fatigue (3 items); communication (2 items); mental health (5 items); social functioning (5 items); and frequency of symptoms (14 items). Each item is scored on a 5-point scale: the higher the score, the better the swallow-related quality of life. Completion of the questionnaire takes 15-30 min. The Turkish version of the Swallowing Quality of Life is considered the gold standard for determining dysphagia specific quality of life in patients with dysphagia.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start19 Dec 2023
- Primary completion19 Feb 2024 (estimated)
- Study completion19 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserrefe Nur Keles, Gazi University
- Investigators
- Muserrefe Nur Keles, PhD, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197451
- Sponsor's protocol ID
- 187765
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keles MN, Inal Ozun O, Gesoglu Demir T, Sarioglu Ermumcu SG, Sengeze N. Validity and Reliability of the M.D. Anderson Dysphagia Inventory in Turkish Patients with Neurological Disease. Folia Phoniatr Logop. 2025;77(2):205-214. doi: 10.1159/000543534. Epub 2025 Jan 15.
PubMed 39813997
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of a Turkish Version of MD Anderson Dysphagia Inventory for Neurogenic Patients
- ClinicalTrials.gov ID
- NCT06197451
- Acronym / sponsor ID
- 187765
- Conditions
- Dysphagia, Neurologic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 19 Feb 2024 (estimated)
- Study completion
- 19 May 2024 (estimated)
- First posted
- 9 Jan 2024 (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 M.D. Validity of the Turkish version of the Anderson Dysphagia Inventory for the Turkish population, reliability, and cultural adaptation.
Detailed description
Oropharyngeal dysphagia (OD) is a common finding in patients with neurogenic disorders.
Swallowing disorder can be acute or chronic in nature. For example, acute OD is observed in patients after stroke, head trauma, neurosurgical intervention, or in patients with Guillain-Barré syndrome. Chronic OD may develop in patients who do not recover after a stroke. Degenerative OD, Parkinson's disease, amyotrophic lateral sclerosis, myasthenia gravis, Huntington's disease, myotonic dystrophy type 1 and multiple sclerosis It is seen in patients with progressive neurological diseases. The prevalence of OD in neurogenic patients varies from 3% to 50% in stroke patients and up to almost 100% in patients with Huntington's disease. The OD can lead to weight loss, malnutrition, social isolation, aspiration pneumonia, and reduced health-related quality of life (QoL). Some studies have reported that dysphagia-specific QoL is weakly associated with OD severity measured using, among other things, fiberoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopy of swallowing (VFS). Therefore, dysphagia-specific QoL questionnaires used alongside these instrumental assessments add value by providing insight into patients' perception of OD, which can be taken into account in the treatment plan. There are dysphagia-specific quality-of-life questionnaires that are actively used today: Swallowing Quality of Life Questionnaire (SWAL-QOL, 44 items), Swallowing Disability Index (30 items), Dysphagia Handicap Index (25 items) and M.D. Anderson Dysphagia Inventory (MDADI, 20 items). Multidisciplinary dysphagia clinics in our country mostly focus on the head and neck. It is visited by patients with OD of oncological or neurological origin.The M. D. Anderson dysphagia inventory is an easier inventory to perform since it has a smaller number of questions and contains more standard questions compared to other currently used questionnaires. Other questionnaires, such as the SWAL-QOL-TR and the Swallowing Disability Index, are longer than the MDADI and take more time to complete. The purpose of this study is M.D. Validity of the Turkish version of the Anderson Dysphagia Inventory for the Turkish population, reliability and cultural adaptation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Turkish Version of M. D. Anderson Dysphagia InventoryPatients 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. |
| 2 | – | Other: Turkish Version of M. D. Anderson Dysphagia InventoryHealthy subjects The second group consists of 50 healty participants will given the MDADI consists of 20 questions and Swallowing Quality-of-Life Questionnaire. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with diagnosed with neurologic disorder and having oropharyngeal dysphagia and healthy adults
Key inclusion criteria (7 listed)
- Diagnosed with neurologic disorder
- Able to speak, read, understand and write in Turkish
- History of dysphagia during 6 months
- Able to speak, read, understand and write in Turkish
- Healthy adults
Key exclusion criteria (3 listed)
- Mini Mental State Examination score below 23 points
- History of head and neck cancer (HNC),
- Age below 18 or above 85 years.
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 |
|---|---|---|
| Turkish Version of M. D. Anderson Dysphagia InventoryTurkish Validation and Cultural Adaptation of M. D. Anderson Dysphagia Inventory in Neurologic Patients | Other | 1, 2 |
Primary outcome
Turkish Version of M. D. Anderson Dysphagia Inventory
Time frame: Baseline
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.
Turkish Version of M. D. Anderson Dysphagia Inventory
Time frame: Two weeks
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.
1 secondary outcome
The Swallowing Quality-of-Life Questionnaire
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 39813997Keles MN, Inal Ozun O, Gesoglu Demir T, Sarioglu Ermumcu SG, Sengeze N. Validity and Reliability of the M.D. Anderson Dysphagia Inventory in Turkish Patients with Neurological Disease. Folia Phoniatr Logop. 2025;77(2):205-214. doi: 10.1159/000543534. Epub 2025 Jan 15.
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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.
Muserrefe Nur Keles, PhD study chair
Gazi 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 Dysphagia and Neurologic Disorder, run by Gazi 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 7 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: status not confirmed, as of the sponsor's last update on 9 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muserrefe Nur Keles, PhD (5426622464 ext. +90, muserrefkeles19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Version of M. D. Anderson Dysphagia Inventory (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197451, which also lists 1 linked publication.
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 9 Jan 2024.