- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03241615
Dysphagia Symptom Severity and Quality of Life
January 1, 2024 updated by: SELEN SEREL ARSLAN, Hacettepe University
The Relationship Between Dysphagia Symptom Severity and Quality of Life
The aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The dysphagia related quality of life and perceived dysphagia symptom severity by patients will be used as a complementary information on oropharyngeal dysphagia.
Thus, the aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06100
- Hacetttepe University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Patients who have neurogenic dysphagia and willing to participate in the study, being over the age of 20, normal cognitive function (24 points according to the Mini Mental State Examination), and having clinically stable neurological disease will be included.
Description
Inclusion Criteria:
- Willing to participate in the study
- Being over the age of 20
- Normal cognitive function
- Suffering from dysphagia at least one month
Exclusion Criteria:
- Being under the age of 20 and above 65 years.
- Abnormal cognitive function
- Clinically unstable neurological disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neurogenic dysphagia
Patients with neurogenic dysphagia who will willing to participate in the study, being over the age of 18, normal cognitive function ([24 points according to the Mini Mental State Examination), suffering from dysphagia at least one month, and having clinically stable neurological disease will be included.
Dysphagia evaluation will be performed.
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Dysphagia evaluation is performed in a clinical setting by an eating assessment tool.
Swallowing related quality of life is also assessed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dysphagia symptom severity
Time Frame: 1 month
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Dysphagia symptom severity will be determined by an eating assessment tool.
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1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life assessment
Time Frame: 1 month
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Swallowing related quality of life will be determined by an dysphagia specific quality of life instrument called Swallow Quality of Life.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SELEN SEREL ARSLAN, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2017
Primary Completion (Actual)
September 8, 2017
Study Completion (Actual)
September 8, 2017
Study Registration Dates
First Submitted
August 3, 2017
First Submitted That Met QC Criteria
August 3, 2017
First Posted (Actual)
August 7, 2017
Study Record Updates
Last Update Posted (Estimated)
January 3, 2024
Last Update Submitted That Met QC Criteria
January 1, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HACETTEPEUNIVERSITY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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