- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816098
The Accuracy of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly
January 21, 2019 updated by: Hsiao-chan, Lai, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
The Accuracy of Chinese Version of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly
The aim of this research was to examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
40
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
40 elderly inpatients age over 65 are included in this study.
Description
Inclusion Criteria:
- (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia
Exclusion Criteria:
- (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) Allergy to barium sulfate suspension
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 |
---|
elderly patients with dysphagia
|
elderly patients without dysphagia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swallowing Disturbance Questionnaire
Time Frame: At the baseline
|
Chinese version of Swallowing Dysphagia Questionnaire consists of 15 questions regarding oral and pharyngeal stage of dysphagia.
Subjects are asked to fill out the questionnaire concerning current state and during the past year using a 4-point scale.
|
At the baseline
|
Videofluroscopy Swallowing Study (VFSS)
Time Frame: At the baseline
|
VFSS studies are conducted using 4 different consistencies: thin liquid, nectar-thick liquid, puree, and cookie.
Subjects are asked to take 2 trials for each consistency to assess if any oral or pharyngeal dysphagia occurs.
|
At the baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical water test
Time Frame: At the baseline
|
Each subject takes 3 trials of 3cc-water using a dropper.
Then sequential water drinking is assessed (about 60-70 ml).
We assess: coughing, choking, voice changes.
At least one symptom means dysphagia.
|
At the baseline
|
Mini-Mental State Examination (MMSE)
Time Frame: At the baseline
|
Mini-Mental State Examination was used to identify subjects' cognitive state.The following four cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=19-23; moderate cognitive impairment=10-18; and severe cognitive impairment<9.
|
At the baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
February 11, 2019
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
January 21, 2019
First Submitted That Met QC Criteria
January 21, 2019
First Posted (Actual)
January 25, 2019
Study Record Updates
Last Update Posted (Actual)
January 25, 2019
Last Update Submitted That Met QC Criteria
January 21, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-XD-080
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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